Abiraterone acetate for patients with metastatic castration resistant prostate. Medical search. Frequent questions

Prostate cancer (PC) is the second leading cause of cancer death among US men and accounts for considerable healthcare expenditures. (statinmed.com)
metastatic castration-resistant prostate cancer (CRPC). (nih.gov)
metastatic high-risk castration-sensitive prostate cancer (CSPC). (nih.gov)
On August 11, the U.S. Food and Drug Administration (FDA) approved the fixed-dose combination of niraparib and abiraterone acetate (Akeega), with prednisone, for adult patients with deleterious or suspected deleterious BRCA -mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved test. (ascopost.com)
Efficacy was evaluated in cohort 1 of MAGNITUDE (ClinicalTrials.gov identifier NCT03748641 ), a randomized, double-blind, placebo-controlled trial that enrolled 423 patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer. (ascopost.com)
Patients with metastatic castration-resistant prostate cancer were eligible if they had not received prior systemic therapy in the metastatic castration-resistant prostate cancer setting except for a short duration of prior abiraterone acetate plus prednisone (up to 4 months) and ongoing androgen-deprivation therapy. (ascopost.com)
No benefit was observed in patients with metastatic castration-resistant prostate cancer without an HRR gene mutation (cohort 2 of MAGNITUDE) as the criterion for futility was met. (ascopost.com)
The major efficacy outcome measure was radiographic progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 for soft tissue and Prostate Cancer Working Group 3 criteria for bone, assessed by blinded independent central review. (ascopost.com)
Among all patients with metastatic castration-resistant prostate cancer treated with niraparib and abiraterone acetate plus prednisone in cohort 1 of MAGNITUDE (n = 423), 27% required a blood transfusion, including 11% who required multiple transfusions. (ascopost.com)
Since 1947, Dana-Farber's sole focus has been to provide expert cancer care and groundbreaking treatments for adult and pediatric patients. (dana-farber.org)
Each year, thousands of patients from around the world come to Dana-Farber for their cancer care. (dana-farber.org)
This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. (dana-farber.org)
Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI). (dana-farber.org)
Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer [mHSPC] are eligible). (dana-farber.org)
Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions. (dana-farber.org)
Vogelzang is actively involved in many research studies to test new therapies and treatments including: A double-blind, randomised, multiplied dose, Phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases. (wikipedia.org)
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy. (wikipedia.org)
A Registry of Sipuleucel-T Therapy in men with advanced prostate Cancer. (wikipedia.org)
Open label, dose escalation, selected dose comparison trail of TOK-001 for the Treatment of Chemotherapy naïve castration resistant Prostate Cancer. (wikipedia.org)
Vogelzang was the principal investigator at the University of Chicago for Cancer and Leukemia Group B (CALGB) from 1988 to 1999, and chair of the CALGB Prostate Committee from 1993 to 1999. (wikipedia.org)
For more than ten years, Vogelzang has served on the Medical and Scientific Advisory Boards for Us TOO, a prostate cancer education and support network for persons affected by prostate cancer. (wikipedia.org)
Poorer response to treatment of metastatic castration-resistant prostate cancer by AA/P ( abiraterone acetate plus prednisone ). (snpedia.com)
PMID 18006912 ] CYP17 genetic variation and risk of breast and prostate cancer from the National Cancer Institute Breast and Prostate Cancer Cohort Consortium (BPC3). (snpedia.com)
Genetic variants and prostate cancer risk: candidate replication and exploration of viral restriction genes. (snpedia.com)
PMID 21229561 ] CYP17 gene polymorphisms and prostate cancer risk: A meta-analysis based on 38 independent studies. (snpedia.com)
Common Genetic Variation in CYP17A1 and Response to Abiraterone Acetate in Patients with Metastatic Castration-Resistant Prostate Cancer. (snpedia.com)
In study B, 23 patients with castration-resistant prostate cancer received probes for CYP3A4 (midazolam), CYP2C9 (warfarin), CYP2C19 (omeprazole), and CYP2C8 (pioglitazone), and transporter substrates for P-glycoprotein (P-gp) (fexofenadine) and breast cancer resistance protein (BCRP)/organic anion transporting polypeptide (OATP) 1B1 (rosuvastatin) at baseline and after repeat once-daily administration of apalutamide 240 mg to steady state. (springer.com)
Apalutamide treatment and metastasis-free survival in prostate cancer. (springer.com)
An open-label, multicenter, phase Ib study investigating the effect of apalutamide on ventricular repolarization in men with castration-resistant prostate cancer. (springer.com)
Efficacy and safety of abiraterone acetate in elderly (75 years or older) chemotherapy naïve patients with metastatic castration resistant prostate cancer. (springer.com)
Potential drug-drug interactions with abiraterone in metastatic castration-resistant prostate cancer patients: a prevalence study in France. (springer.com)
The US Food and Drug Administration (FDA) has approved niraparib and abiraterone acetate (Akeega, Janssen Pharmaceuticals) to treat BRCA -positive, metastatic castration-resistant prostate cancer in adult patients with deleterious or suspected deleterious disease, as determined by an FDA-approved test. (medscape.com)
About 10% - 15% of patients who develop metastatic castration-resistant prostate cancer have BRCA gene alterations, and those patients are more likely to have aggressive disease, poor outcomes, and shorter survival. (medscape.com)
Therefore, this new agent "brings an important treatment option to patients with prostate cancer as they consider their road ahead," said Shelby Moneer , vice president of patient programs and education at ZERO Prostate Cancer. (medscape.com)
Cite this: FDA OKs Combo Niraparib, Abiraterone Acetate for Prostate Cancer - Medscape - Aug 11, 2023. (medscape.com)
Abiraterone acetate is an androgen biosynthesis inhibitor used in the treatment of prostate cancer. (ijpsonline.com)
Metastatic Castration-Resistant Prostate (MCRP) cancer is a major category of malignance, which is one of the most common cancers in the United States and the second most common cause of cancer death among men. (ijpsonline.com)
The therapy for metastatic prostate cancer involves suppressing testosterone production through androgen deprivation therapy. (ijpsonline.com)
Abiraterone Acetate (ABT), the first compound through the inhibition of adrenal gland production of testosterone, increases the overall survival in Castrate-Resistant Prostate Cancer (CRPC) patients. (ijpsonline.com)
This growth was partially offset by biosimilar and generic competition, with declines primarily in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer. (jnj.com)
RARITAN, N.J., September 17, 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today multiple data presentations from its prostate cancer and solid tumor portfolios will be featured at the European Society for Medical Oncology (ESMO) Annual Congress 2019, taking place September 27 to October 1 in Barcelona, Spain. (jnj.com)
Janssen is focused on addressing areas of unmet need in both prostate cancer and solid tumors, and this year's ESMO Annual Congress provides an opportunity to share these important study results for both approved and investigational therapies," said Mark Wildgust, Ph.D., Vice President, Global Medical Affairs, Oncology, Janssen Research & Development, LLC. (jnj.com)
In particular, we look forward to presenting new data for ERLEADA ® and niraparib, which reinforce our continued commitment to improve outcomes for patients diagnosed with prostate cancer across the disease spectrum. (jnj.com)
The novel treatment, SnyKIR-110, is a T-cell therapy designed to treat patients with mesothelioma, cholangiocarcinoma (bile duct cancer) and ovarian cancer. (medworm.com)
RARITAN, N.J., February 28, 2023 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet (DAT), plus prednisone, for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). (medworm.com)
The article by Ruch and Hussain provides a comprehensive overview of the progress that has been made in translating basic science findings in prostate cancer biology to clinical trials. (cancernetwork.com)
Targets that have been identified as having the potential to improve survival in patients with castration-resistant prostate cancer stem from research in angiogenesis, bone metabolism, immunotherapy, androgen metabolism and receptor regulation, and apoptosis. (cancernetwork.com)
1,2] Advances have also been made in supportive care: denosumab (XGEVA) demonstrated improvement in skeletal-related events in patients with castration-resistant prostate cancer compared to the standard of care, zoledronic acid (Zometa). (cancernetwork.com)
Since the current gold standard for approval of drugs in castration-resistant prostate cancer is based on overall survival, prospective evaluation of these types of markers as a surrogate for survival is clearly needed, particularly with the plethora of new agents. (cancernetwork.com)
The FDA has approved niraparib plus abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive, metastatic castration-resistant prostate cancer, as detected by an FDA-approved test. (onclive.com)
The FDA has approved the first-and-only dual action tablet (Akeega) combining niraparib (Zejula) and abiraterone acetate (Zytiga), given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA -positive, metastatic castration-resistant prostate cancer (mCRPC), as detected by an FDA-approved test. (onclive.com)
As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,' Kim Chi, MD, medical oncologist at BC Cancer - Vancouver and principal investigator of the phase 3 MAGNITUDE study, said in a news release. (onclive.com)
The approval of AKEEGA brings an important treatment option to patients with prostate cancer as they consider their road ahead, and it also highlights the importance of genetic testing and precision medicine for this disease,' Shelby Moneer, MS, CHES, vice president of patient programs and education, ZERO Prostate Cancer, added. (onclive.com)
1 'All individuals diagnosed with prostate cancer should consider genetic testing, especially those from racial and ethnic minority groups who tend to have worse cancer outcomes. (onclive.com)
This is imperative to close the racial and ethnic disparities in prostate cancer health outcomes. (onclive.com)
U.S. FDA approves AKEEGA (niraparib and abiraterone acetate), the first-and-only dual action tablet for the treatment of patients with BRCA-positive metastatic castration-resistant prostate cancer. (onclive.com)
Invited discussant of the ACIS study, Joshi J. Alumkal, MD , leader of the Genitourinary Medical Oncology Section at the University of Michigan Rogel Cancer Center, noted that the toxicities were slightly higher with apalutamide plus abiraterone acetate/prednisone, including fatigue, hypertension, skin rash, cardiac disorders, and grade 3 and 4 events. (ascopost.com)
The lack of overall survival benefit or second radiographic progression-free survival benefit in other studies, including the ALLIANCE A031201 study that failed to show a benefit with combining androgen receptor-signaling inhibitors vs a single-agent androgen receptor-signaling inhibitor, raises questions about the utility of combining drugs that target the androgen receptor in men with castration-resistant prostate cancer," Dr. Alumkal told listeners. (ascopost.com)
Because castration-resistant prostate cancer is not just one disease, and tumors from individual patients clearly responded differently, Dr. Alumkal closed his discussion with this comment: "The key question as we return to the clinic is what is the tumor biology in the patient sitting before us? (ascopost.com)
It is critical to understand that to move the needle on outcomes for patients with castration-resistant prostate cancer, especially those resistant to androgen receptor-signaling inhibitors. (ascopost.com)
More interestingly, their expression has been associated with patient survival in non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma, esophageal, pancreatic and colorectal carcinoma, with the data commonly suggesting a negative prognostic role. (journaltocs.ac.uk)
Background: Abiraterone acetate became a referral treatment for metastatic castration-resistant prostate cancer (mCRPC) in a post-docetaxel setting despite a remarkable percentage of cardiovascular adverse events (AEs). (journaltocs.ac.uk)
Zytiga life expectancy is something that men considering treatment for prostate cancer will want to understand to help them make an informed decision about treatment. (prostate.net)
According to the American Cancer Society, a man's risk of developing prostate cancer in his lifetime is 1 in 6. (prostate.net)
On the other hand survival is generally good with 1 in 36 men dying from prostate cancer. (prostate.net)
In 2013 there will be over 235,000 new cases of prostate cancer in the U.S. and about 30,000 deaths. (prostate.net)
Zytiga is used for men who have castrate-resistant prostate cancer. (prostate.net)
Testosterone is a hormone that allows prostate cancer to grow and spread. (prostate.net)
Zytiga may also be used for prostate cancer that has spread to other parts of the body. (prostate.net)
The treatment also has been shown to increase time that you may live with prostate cancer, but not have worsening of your disease as measured by cat scans or bone scans. (prostate.net)
The theory behind combining drugs is that if each of the drugs attacks the prostate cancer in a different way, it might result in more effective treatment. (prostate.net)
Interim Analysis (IA) Results of COU-AA-302, a Randomized, Phase 3 Study of Abiraterone Acetate (AA) in Chemotherapy-Naïve Patients (pts) With Metastatic Castration-Resistant Prostate Cancer (mCRPC). (prostate.net)
Abiraterone and increased survival in metastatic prostate cancer. (prostate.net)
A clinical trial is studying whether combining Provenge with Zytiga for men with metastatic castrate-resistant prostate cancer leads to meaningful outcomes. (prostate.net)
You may be familiar with research indicating that what you eat can have a significant impact on your risk of developing prostate cancer. (prostate.net)
But did you know there may be an association between when you eat and prostate cancer risk as well? (prostate.net)
Today's world of prostate cancer (PCa) is a far cry from what it was in your dad's day. (prostate.net)
New knowledge about the disease includes a better understanding of prostate anatomy, PCa genomics, the behavior of cancer cells, the role of lifestyle, etc. (prostate.net)
When is Watchful Waiting Best for Prostate Cancer? (prostate.net)
You've been diagnosed with prostate cancer, and your doctor has suggested something called "watchful waiting" rather than attempting more aggressive treatment options. (prostate.net)
What is Hormone Therapy for Prostate Cancer? (prostate.net)
A diagnosis of prostate cancer is almost certainly one of the most significant events in any man's life. (prostate.net)
Results from the placebo-controlled phase 3 PROpel trial showed that adding the PARP inhibitor olaparib (Lynparza) to frontline abiraterone acetate (Zytiga) significantly improved radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC). (urologytimes.com)
Patients could have received docetaxel in the metastatic hormone-sensitive prostate cancer (mHSPC) setting, but no prior abiraterone was allowed. (urologytimes.com)
The open-label phase 3 VISION trial (NCT03511664) accrued patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who received at least 1 novel androgen axis drug (eg, enzalutamide [Xtandi] or abiraterone acetate [Zytiga]) and were previously treated with 1 to 2 taxane regimens. (urologytimes.com)
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Prostate cancer a type of malignancy that occurs in the prostate gland. (delveinsight.com)
Prostate cancer is one of the most common types of cancer found in men. (delveinsight.com)
This cancer usually grows slowly and is confined to the prostate gland initially, where it may not cause serious harm. (delveinsight.com)
According to the Cancer Treatment Centers of America (CTCA) , more than 99% of prostate cancers are adenocarcinomas, which develop in the gland cells. (delveinsight.com)
The symptoms of prostate cancer do not usually appear until the prostate is large enough to affect the tube that carries urine from the bladder out of the penis. (delveinsight.com)
Clinical Stage and treatment pattern are key factors in Prostate Cancer. (delveinsight.com)
Many patients undergo regular prostate cancer screening before symptoms appear. (delveinsight.com)
It is not clear, however, if the benefits of prostate cancer screening outweigh the risks for most men. (delveinsight.com)
If the result of one of these tests is abnormal, patients will probably need a prostate biopsy to know for sure the occurrence of cancer. (delveinsight.com)
The prostate cancer experts develop a comprehensive treatment plan for each patient specifically. (delveinsight.com)
Treatment strategies of prostate cancers depend on the stage and progression of cancer. (delveinsight.com)
However, prostate cancer often grows slowly, and active surveillance may be the preferred treatment option for some men, with the oncologist closely monitoring the disease with tests and holding off on treatment until a later date. (delveinsight.com)
For men who undergo radiotherapy for localised prostate cancer, the precise targeting capabilities of MRI guidance resulted in fewer toxicities and better quality of life, as judged by patients and the doctors treating them, according to new research from UCLA Jonsson Comprehensive Cancer Center. (ecancer.org)
Stereotactic body radiotherapy for prostate cancer usually delivers radiation in five or fewer precisely targeted doses. (ecancer.org)
This clinical trial, Magnetic Resonance Imaging-Guided Stereotactic Body Radiotherapy for Prostate Cancer (MIRAGE), was led at UCLA and included 154 analyzable patients with prostate cancer who were randomised to either a CT-guidance arm (76 patients) or an MRI-guidance arm (78 patients). (ecancer.org)
Although additional studies will need to confirm these benefits over time, we're hopeful that these results will lead to better outcomes for men with prostate cancer. (ecancer.org)
BISCAY is an open-label, randomised, multi-drug, biomarker-directed, phase Ib study conducted in patients with muscle invasive bladder cancer. (ogkologos.com)
News digest - targeted drug approval, microbubble 'warheads' and prostate cancer. (ogkologos.com)
The nurse is not a specialist in prostate cancer. (cancer.org)
It now seems that the cancer has become resistant to hormone therapy and is starting to increase again. (cancer.org)
A different HT cocktail may be in order but eventually these drugs will cease to be effective for advanced stage prostate cancer. (cancer.org)
Mingyang Song of Harvard Medical School and Massachusetts General Hospital reported that after diagnosis of non-metastatic colorectal cancer, ingesting more fiber will reduce the specific mortality and overall mortality of colorectal cancer. (cancerfax.com)
Increasing fiber intake after diagnosis can benefit patients with colorectal cancer. (cancerfax.com)
With a median follow-up of 8 years, 773 patients died, of which 174 died from colorectal cancer. (cancerfax.com)
CancerFax is the most trusted international patient facilitator working with top cancer hospital's in the world like MD Anderson, Dana Farber, Asan, NCC Japan, Sheba, Beijing Cancer Institute and Apollo to bring you best of therapies and drugs. (cancerfax.com)
AKEEGA is intended for the treatment of metastatic castration-resistant prostate cancer. (pharmaceutical-technology.com)
The US Food and Drug Administration (FDA) has approved the Janssen Pharmaceutical Companies of Johnson & Johnson's AKEEGA for treating patients with metastatic castration-resistant prostate cancer (mCRPC). (pharmaceutical-technology.com)
Janssen research and development (solid tumours) clinical development vice-president Kiran Patel stated: "Janssen's legacy of advancing the science of prostate cancer has contributed to the evolution of transformational treatment approaches for more than a decade. (pharmaceutical-technology.com)
This milestone, which marks the approval of Janssen's third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive mCRPC. (pharmaceutical-technology.com)
OBJECTIVE: To evaluate the efficacy of enzalutamide (Enz) as fourth- or fifth-line treatment in men with metastasized castration-resistant prostate cancer (mCRPC), by analyzing a retrospective cohort of heavily pretreated patients. (ru.nl)
Up to 40% of male patients diagnosed with prostate cancer develop metastatic disease that generally responds to initial chemical or surgical castration, but this eventually progresses despite castrate levels of testosterone, termed castration-resistant prostate cancer (CRPC). (urotoday.com)
Denosumab, a monoclonal antibody against receptor activator of nuclear factor-kB ligand, was shown to be superior to zoledronic acid for prevention of skeletal-related events in prostate cancer patients with metastatic bone disease. (urotoday.com)
New technology provides a major step forward in diagnosing and treating prostate cancer. (pcctc.org)
A 72-year-old white male patient with prostate cancer presents in early 2020 with a biochemical recurrence showing that his prostate-specific antigen (PSA) has increased with a projected doubling time (PSA-DT) of 6 months. (advancedpractitioner.com)
He was first diagnosed with prostate cancer in 2015 and underwent a retropubic radical prostatectomy to remove the entire prostate and tissue around it. (advancedpractitioner.com)
In December 2021, the patient develops castration-resistant prostate cancer (CRPC), and his PSA-DT has accelerated to 3 months. (advancedpractitioner.com)
In persons with prostate cancer, the cancer should have progressed after treatment with one hormonal therapy. (advancedpractitioner.com)
Making decisions around duration and dosing of BMAs in metastatic breast cancer and castration-resistant prostate cancer is difficult but critical because patients are living longer. (advancedpractitioner.com)
Results from the open-label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer regarding safety of long-term denosumab confirmed the known safety profile of denosumab with long-term administration for a median 19.1 months (up to 5 years) in metastatic breast cancer and a median 12.0 months (up to 5.6 years) in metastatic prostate cancer. (advancedpractitioner.com)
There are a number of factors to weigh in managing the treatment of the patient's prostate cancer at this point, including renal function, efficacy, convenience, response to therapy, and the number and sites of metastasis. (advancedpractitioner.com)
Risk of fracture after androgen deprivation for prostate cancer. (advancedpractitioner.com)
Zoledronic acid is a bisphosphonate that can reduce the incidence of SREs in cancer patients. (advancedpractitioner.com)
It is approved by the U.S. Food and Drug Administration for treating metastatic bone disease in multiple cancers, including lung cancer, based on data from phase III trials for zoledronic acid. (advancedpractitioner.com)
Zoledronic acid is generally administered every 4 weeks to reduce the incidence of SREs in patients with metastatic lung cancer. (advancedpractitioner.com)
Certain therapies that are used to treat osteoporosis, Paget's disease, and other bone conditions can reduce the incidence of SREs in cancer patients. (advancedpractitioner.com)
While determining the optimal dosing of zoledronic acid in metastatic lung cancer is a fluid process, clinicians currently reduce the standard dose if a patient has renal insufficiency. (advancedpractitioner.com)
Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial-the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. (advancedpractitioner.com)
Impact of extended-interval versus standard dosing of zoledronic acid on skeletal events in non-small-cell lung cancer and small-cell lung cancer patients with bone metastases. (advancedpractitioner.com)
Abiraterone acetate is a CYP17 inhibitor used to treat metastatic castration-resistant prostate cancer when combined with prednisone. (theindianpharma.com)
BARCELONA, Spain - Targeting faulty DNA repair mechanisms in advanced castration resistant prostate cancer can slow progression and potentially improve survival, paving the way for a new approach to treatment of the most common form of cancer in men. (esmo.org)
Data from the PROfound trial, presented at the ESMO Congress 2019 , show that olaparib delayed cancer progression by about four months compared to new hormonal agents (enzalutamide or abiraterone acetate) in patients with metastatic, pre-treated prostate cancer whose cancer cells had faulty DNA repair genes. (esmo.org)
To see such a significant effect on disease progression and other clinically relevant effects such as pain progression and objective response rate is a remarkable achievement in such heavily pre-treated patients with prostate cancer. (esmo.org)
Prostate cancer has lagged behind all other common solid tumours in the use of molecularly targeted treatment so it is very exciting that now we can personalise an individual's treatment based on specific genomic alterations in their cancer cells," said study author Prof Maha Hussain, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, USA. (esmo.org)
Each year, prostate cancer is diagnosed in over 1.2 million men worldwide and kills over 350,000. (esmo.org)
However, treatment options are limited if the cancer spreads to other parts of the body and becomes resistant to hormonal treatment (metastatic castration-resistant prostate cancer, mCRPC). (esmo.org)
Targeting DNA repair pathways in cancer cells is already used to treat breast and ovarian cancer in patients with mistakes in two types of DNA repair gene, BRCA1 and BRCA2 . (esmo.org)
This is impressive because it is considerably higher than the 35-40% improvements with which we've been very satisfied in previous prostate cancer studies in this more advanced disease setting. (esmo.org)
Overall, these data show that, like breast and lung cancers, prostate cancer is not one but many different diseases and we need to start identifying different groups of patients and treating them with targeted therapy," she concluded. (esmo.org)
e.g., enzalutamide, abiraterone acetate) are administered in daily practice for men with metastatic castration-resistant prostate cancer (mCRPC). (figshare.com)
CURE spoke with Akash Patnaik about immunotherapy's role in prostate cancer. (curetoday.com)
Immunotherapy may not be as prominent in prostate cancer as it is in other tumor types, but progress is still being made, says Akash Patnaik, an assistant professor of Medicine at the University of Chicago Medicine. (curetoday.com)
Patnaik discussed immunotherapy and personalized medicine tactics in the field of prostate cancer, as well as the work that needs to be done with existing targeted therapies and biomarker development. (curetoday.com)
What are the latest advancements with immunotherapy and personalized medicine in prostate cancer? (curetoday.com)
The challenge, particularly in the context of prostate cancer-which is one of the cancers where immune-based therapies have not been home runs—is that there have been limited successes, but clearly, there is room for improvement. (curetoday.com)
Are there immunotherapy combinations that are being studied right now in prostate cancer that have potential? (curetoday.com)
Looking at the therapies that we do have available for patients with prostate cancer, do you find that there are challenges with sequencing? (curetoday.com)
In the context of metastatic castration-resistant prostate cancer, there have been several agents that have been FDA-approved since 2009. (curetoday.com)
This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on abiraterone. (ucsf.edu)
To determine the median time to prostate-specific antigen (PSA) progression by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria. (ucsf.edu)
Prognostic Value of Germline DNA Repair Gene Mutations in De Novo Metastatic and Castration-Sensitive Prostate Cancer. (cdc.gov)
Illustrating Cancer Risk: Patient Risk Communication Preferences and Interest regarding a Novel BRCA1/2 Genetic Risk Modifier Test. (cdc.gov)
A new clinical-genomic model to predict 10-year recurrence risk in primary operable breast cancer patients. (cdc.gov)
Prognostic value of the SPOP mutant genomic subclass in prostate cancer. (cdc.gov)
Short-Term Outcomes of Active Surveillance for Low-Risk Prostate Cancer Among Men with Germline DNA Repair Gene Mutations. (cdc.gov)
Plasma cell-free DNA-based predictors of response to abiraterone acetate/prednisone and prognostic factors in metastatic castration-resistant prostate cancer. (cdc.gov)
Small molecule drug, Niraparib combined with abiraterone acetate (AA) and prednisone (P) significantly reduces the risk of disease progression, or death, in patients with a type of prostate cancer, a consultant in Spain has said. (outsourcing-pharma.com)
If approved the combination will be the first DAT available in the European Union for first-line treatment of adults with gene-mutated metastatic castration resistant prostate cancer (mCRPC) with BRCA1/2 (the genes that can offer protection from certain cancers) mutations. (outsourcing-pharma.com)
During their research Janssen found evidence that shows that prostate cancer is the most common cancer in men in Europe and despite treatment advances, for those whose cancer has progressed to mCRPC, the impact can be devastating with an average overall survival ranging from 13-36 months. (outsourcing-pharma.com)
Consultant oncologist, Elena Castro, who works at Sanitaria Hospital, Madrid, said: "Metastatic castration-resistant prostate cancer remains a lethal disease, with high unmet needs in terms of treatment options, particularly for patients with BRCA1/2 gene mutations. (outsourcing-pharma.com)
In recent years, we've focused on precision medicine in prostate cancer because we know patients with gene mutations, such as BRCA1/2, face a worse prognosis than those without," said Martin Vogel, EMEA therapeutic area lead oncology, Janssen-Cilag GmbH. (outsourcing-pharma.com)
Prostate cancer is a heterogeneous disease made up of many biologically distinct subpopulations. (outsourcing-pharma.com)
At Janssen, we are dedicated to continued innovation in prostate cancer and now look forward to working with health authorities to bring this niraparib-based treatment option to patients as soon as possible. (outsourcing-pharma.com)
Our research focuses on prostate cancer and steroid metabolism. (aacc.org)
Prostate cancer is the most commonly diagnosed cancer and the second most common cause of cancer-related death among American men. (aacc.org)
Prostate cancer progression depends on continued androgen receptor (AR) activity. (aacc.org)
However, in most advanced cases, although the cancer initially responds to ADT, after time, it becomes resistant, and castration-resistant prostate cancer (CRPC) develops. (aacc.org)
This approach will provide new knowledge about available therapeutic agents used in CRPC by identifying their metabolites and examining the role these metabolites play in prostate cancer. (aacc.org)
Conversion of abiraterone to D4A drives anti-tumour activity in prostate cancer. (aacc.org)
Redirecting abiraterone metabolism to fine-tune prostate cancer anti-androgen. (aacc.org)
Treatment protocols for prostate cancer are provided below, including general treatment recommendations and those for localized prostate cancer, for recurrent disease, and for advanced or metastatic disease. (medscape.com)
See Prostate Cancer: Diagnosis and Staging , a Critical Images slideshow, to help determine the best diagnostic approach for this potentially deadly disease. (medscape.com)
Also, see the Advanced Prostate Cancer: Signs of Metastatic Disease slideshow for help identifying the signs of metastatic disease. (medscape.com)
Context The assessment of "soft" endpoints such as health-related quality of life (HRQOL) is increasingly relevant when evaluating the optimal treatment sequence of novel therapeutic options in patients with advanced prostate cancer (PCa). (isidl.com)
Evidence synthesis Regarding HRQOL assessment, the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire was used in 11 of 14 studies, the European Quality of Life 5-Dimensions (EQ-5D) questionnaire in six of 14 studies, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) in two of 14, and its prostate-specific amendment QLQ-PR25 was used in one of 14 studies. (isidl.com)
Having performed analytical validation studies, we are now assessing the clinical utility of the upgraded automated Bone Scan Index (BSI) in metastatic castration-resistant prostate cancer (mCRPC). (springeropen.com)
Today's topic is a new antiandrogen for the treatment of men with nonmetastatic, castration-resistant prostate cancer . (medscape.com)
Prostate cancer is usually adenocarcinoma. (msdmanuals.com)
more men die with prostate cancer than of it. (msdmanuals.com)
Довідковий матеріал загального характеру Prostate cancer is usually adenocarcinoma. (msdmanuals.com)
autopsy studies show prostate cancer in 15 to 60% of men aged 60 to 90 years old, with incidence increasing with age. (msdmanuals.com)
The lifetime risk of being diagnosed with prostate cancer is 1 in 6. (msdmanuals.com)
Undifferentiated prostate cancer, squamous cell carcinoma, and ductal transitional carcinoma also occur infrequently. (msdmanuals.com)
Hormonal influences contribute to the course of adenocarcinoma but almost certainly not to other types of prostate cancer. (msdmanuals.com)
Key statistics for prostate cancer. (msdmanuals.com)
Prostate cancer usually progresses slowly and rarely causes symptoms until advanced. (msdmanuals.com)

Finally, Zytiga was able to help some patients delay starting chemotherapy. (prostate.net)
In terms of maybe comparing Zytiga (abiraterone acetate) and Xtandi (enzalutamide), how do you decide if you are going to administer one of those over the other? (curetoday.com)
Kaplan-Meier curves of patients treated with either ZYTIGA ® + prednisone or placebo + prednisone (primary survival, intent-to-treat-analysis). (zytigahcp.com)

The once-daily dual-action tablet is the first-and-only orally administered treatment combining the PARP inhibitor niraparib with abiraterone acetate. (medscape.com)
3] On April 28, 2011, abiraterone, a 17,20 lyase inhibitor that can induce the near total abrogation of testosterone, was approved for patients with chemoresistant disease. (cancernetwork.com)
In this multicenter phase 2 trial, the authors examined the safety and efficacy of adding the immune checkpoint inhibitor pembrolizumab to standard TMT in this patient population. (urologytimes.com)
A once-daily dual-action tablet, AKEEGA comprises a highly selective poly (ADP-ribose) polymerase inhibitor, niraparib, and an androgen biosynthesis inhibitor, abiraterone acetate. (pharmaceutical-technology.com)
In the PROfound trial, researchers from across Europe, North America, South America, Asia and Australia compared the poly-ADP ribose polymerase (PARP) inhibitor, olaparib, with the latest forms of hormonal treatment in patients with mCRPC and key faulty DNA repair genes. (esmo.org)
The Phase 3 PROfound trial compared the efficacy of the PARP inhibitor, olaparib, and physician's choice of new hormonal agent treatment with enzalutamide or abiraterone in two groups of men with mCRPC. (esmo.org)
Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). (indiangenericmedicines.com)

Patients could have received prior docetaxel or androgen receptor-targeted therapies in earlier disease settings. (ascopost.com)
Random assignment was stratified by prior receipt of docetaxel, prior receipt of androgen receptor-targeted therapy, prior receipt of abiraterone acetate plus prednisone, and BRCA status. (ascopost.com)
Conclusions: Abiraterone acetate showed a favorable safety profile in mCRPC patients with cardiovascular comorbidities or risk factors in a post-docetaxel setting, but further studies are needed to confirm our findings and to explore other settings of disease. (journaltocs.ac.uk)
22.5% of patients had received docetaxel at the mHSPC stage. (urologytimes.com)
RESULTS: All patients were treated with docetaxel and abiraterone acetate and 42 patients (89%) with cabazitaxel. (ru.nl)
A large phase 3 trial of abiraterone acetate in patients who have progressed following docetaxel based chemotherapy were published in 2011 and dramatically proved that CRPC is still androgen-dependant and responds to CYP17 inhibition. (urotoday.com)
This drug is generally recommended to the patient to receive at least one prior chemotherapy, including docetaxel. (theindianpharma.com)
Three studies included patients with metastatic castration-sensitive prostate PCa, and found beneficial HRQOL effects for abiraterone acetate and docetaxel compared with standard androgen deprivation therapy. (isidl.com)

Screening may involve one or more of the following tests: prostate-specific antigen (PSA), digital rectal exam (DRE), prostate ultrasound, prostate MRI, prostate Mp-MRI. (delveinsight.com)
METHODS: We evaluated toxicity, overall survival (OS), progression-free survival (PFS) and time to prostate-specific antigen (PSA) progression data from 47 CRPC patients treated with fourth- or fifth-line Enz. (ru.nl)
Selecting initial treatment requires assessing the risk of the disease spreading or progressing, which is based on evaluating the patient's life expectancy, comorbidities, biopsy grade (Gleason score), clinical stage, and prostate-specific antigen (PSA) level. (medscape.com)
Automated BSI, prostate-specific antigen (PSA), hemoglobin (HgB), and alkaline phosphatase (ALP) were obtained at baseline. (springeropen.com)
Diagnosis is suggested by digital rectal examination or prostate-specific antigen (PSA) measurement and confirmed by transrectal ultrasound biopsy. (msdmanuals.com)

CONCLUSIONS: Analysis of this retrospective cohort suggests that Enz is well tolerated and that there is a 23% response rate in heavily pretreated CRPC patients, which is comparable with third-line treatment outcomes. (ru.nl)
Recently, we studied the metabolism of abiraterone (Abi), a steroidal compound that is used to treat metastatic CRPC. (aacc.org)
thus, it was important to determine and accurately quantitate all Abi metabolites in CRPC patients. (aacc.org)
Serum samples from patients with CRPC undergoing treatment with Abi acetate were collected. (aacc.org)

A statistically significant improvement in radiographic progression-free survival for niraparib and abiraterone acetate plus prednisone compared to placebo and abiraterone acetate plus prednisone was observed in patients with a BRCA mutation, with a median of 16.6 months vs 10.9 months (hazard ratio [HR] = 0.53, 95% confidence interval [CI] = 0.36-0.79, P = .0014). (ascopost.com)
Patients receiving niraparib and abiraterone acetate plus prednisone should also receive a GnRH analog concurrently or should have had bilateral orchiectomy. (ascopost.com)
The safety profile of niraparib and abiraterone acetate plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. (medscape.com)

However, in the subgroup of 198 (47%) patients with non- BRCA HRR mutations, the radiographic progression-free survival hazard ratio was 0.99 (95% CI = 0.67-1.44) and the overall survival hazard ratio was 1.13 (95% CI = 0.77-1.64), indicating that the improvement in the ITT HRR gene-mutated population was primarily attributed to the results seen in the subgroup of patients with a BRCA mutation. (ascopost.com)
Although the overall cohort (those with and without BRCA mutations) demonstrated a significant improvement in radiographic progression-free survival, the subgroup with non- BRCA homologous recombination repair mutations did not demonstrate a significant improvement in radiographic progression-free survival, which indicates that the benefit observed was "primarily attributed" to the results in the subgroup of patients with BRCA mutations, according to the FDA . (medscape.com)
The phase III ACIS trial met its primary endpoint at 6 months showing that apalutamide plus abiraterone acetate/prednisone (AAP) extended radiographic progression-free survival vs abiraterone acetate/prednisone alone in patients with chemotherapy-naive metastatic castration-resistant prostate. (ascopost.com)
In the multi-centre, placebo-controlled, double-blind, randomised study, a statistically significant risk reduction of 47% was observed for radiographic progression-free survival (rPFS) in BRCA-positive patients. (pharmaceutical-technology.com)
Results from the phase 3 Magnitude study which showed Niraparib being added to AA plus P showed a significantly improved radiographic progression-free survival compared to standard care in untreated mCRPC patients with the mutations. (outsourcing-pharma.com)

This suggests subsequent therapy worked less well in patients enrolled on the apalutamide plus abiraterone acetate/prednisone combination arm vs those enrolled on the abiraterone/prednisone only arm. (ascopost.com)
Prior progression by PCWG3 criteria on one or more androgen signaling inhibitors including abiraterone acetate, enzalutamide, apalutamide, and/or darolutamide. (ucsf.edu)
Two studies included patients with nonmetastatic castration-resistant PCa, and positive HRQOL effects for enzalutamide and apalutamide were observed. (isidl.com)
Patients were randomized 2:1 to apalutamide 240 mg or placebo. (medscape.com)
The study reported a statistically significant reduction in the development of metastatic disease or prolongation of time to metastases associated with apalutamide compared with placebo (40.5 months vs 16.2 months, respectively). (medscape.com)
If some of the men being treated did indeed have metastatic disease, we have to consider whether they would benefit best from apalutamide or enzalutamide, or if giving them chemotherapy would be a better approach. (medscape.com)

We aimed to assess the cardiovascular safety of abiraterone acetate in a real-world series of mCRPC patients treated at our institution. (journaltocs.ac.uk)

The recommended dose of the agent is 200 mg of niraparib and 1,000 mg of abiraterone acetate taken orally once daily in combination with 10 mg of prednisone daily until disease progression or unacceptable toxicity. (ascopost.com)
In patients with such tumours, treatment with olaparib resulted in a 66% greater delay in progression than the new hormonal agents which were used in PROfound. (esmo.org)
Participants may continue study treatment from the time of treatment initiation until confirmed radiographic disease progression per PCWG3 / RECIST 1.1 criteria, unequivocal clinical progression, unacceptable toxicity, or patient withdrawal, whichever occurs first. (ucsf.edu)
We've seen that in these patients, niraparib combined with abiraterone acetate and prednisone significantly reduces the risk of disease progression or death compared to AAP. (outsourcing-pharma.com)
In this clinical study, patients were to continue until disease progression, initiation of new treatment, unacceptable toxicity, or withdrawal. (zytigahcp.com)

An exploratory overall survival analysis in patients with a BRCA mutation demonstrated a median of 30.4 vs 28.6 months (HR = 0.79, 95% CI = 0.55-1.12) favoring the investigational arm. (ascopost.com)
Some of the approaches incorporating these targets have already translated to measurable clinical benefit: sipuleucel-T (Provenge) and cabazitaxel (Jevtana) have demonstrated improvements in median survival of 4.1 and 2.4 months, respectively, in different populations of men with castration-resistant disease. (cancernetwork.com)
Patients with mCRPC who are treated in the frontline setting have a median survival of approximately 3 years in clinical trial settings, Saad noted, adding that about half of patients in real-world practice only receive 1 line of active treatment. (urologytimes.com)
The phase 3 PROfound trial (NCT02987543) demonstrated significantly prolonged rPFS and overall survival (OS) in patients with mCRPC following a next-generation hormonal agent (NHA) with HRR gene alterations. (urologytimes.com)
Newer therapies are extending survival in NSCLC, but the chance of developing bone metastases increases as a patient grows older and lives longer with the disease. (advancedpractitioner.com)
Its predominant benefit lies in the subset of patients who have symptomatic bone metastases where Xofigo has been shown to have a palliative benefit and also a survival benefit. (curetoday.com)
Patients will be followed for overall survival every 90 days (+/- 30 days) from last dose of study treatment, until death, withdrawal of consent, or the end of the study, whichever occurs first. (ucsf.edu)
The company found that patients with mCRPC and BRCA gene mutations are more likely to have aggressive disease, poor outcomes and a shorter survival time. (outsourcing-pharma.com)
In the present study, we retrospectively evaluated the discriminatory strength of the automated BSI in predicting overall survival (OS) in mCRPC patients being treated with enzalutamide. (springeropen.com)

We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with AKEEGA and to help us understand how we can potentially achieve better health outcomes for patients. (medscape.com)
AKEEGA is available in 200mg and 100mg niraparib/1,000mg abiraterone acetate dosages. (pharmaceutical-technology.com)

Embryo-Fetal Toxicity: Abiraterone acetate can cause fetal harm. (nih.gov)
No patients discontinued abiraterone because of toxicity. (journaltocs.ac.uk)
In this trial, we demonstrated that the reduction in treatment volumes facilitated by MRI guidance leads to a significant reduction in moderate physician-scored toxicity and to a reduction in the proportion of patients noting significant decrements in patient-reported outcome metrics in the near term," said Dr. Kishan. (ecancer.org)

Only 17 percent of patients receiving cisplatin alone experienced tumor shrinkage. (wikipedia.org)
Here, we review some of the relevant literature of the role of neutrophils in different stages of the oncogenic process including tumor initiation, growth, proliferation or metastatic spreading and also focus on how neutrophil counts or the neutrophil-to-lymphocyte ratio may be used as a prognostic and predictive biomarker. (biomedcentral.com)
Participants must be willing to undergo metastatic tumor biopsy during Screening. (ucsf.edu)
The use of circulating cell-free tumor DNA in routine diagnostics of metastatic melanoma patients. (cdc.gov)

Immune checkpoint inhibitors have emerged as one of the main new therapeutic options for patients with advanced NSCLC. (journaltocs.ac.uk)
In this review, we summarize the pros and cons regarding the predictive role of PD-L1 expression in candidate patients for checkpoint inhibitors. (journaltocs.ac.uk)

To determine the maximally tolerated dose (MTD) and recommended phase 2 dose (RP2D) of FOR46 in combination with enzalutamide in patients with mCRPC. (ucsf.edu)

The active pharmaceutical ingredient in the medicine Abirapro is Abiraterone acetate with inactive ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, povidone, sodium lauryl sulfate, magnesium stearate, and colloidal silicon dioxide. (theindianpharma.com)

Abiraterone acetate tablets 1,000 mg orally once daily with prednisone 5 mg orally twice daily. (nih.gov)
Patients were randomly assigned 1:1 to receive niraparib at 200 mg and abiraterone acetate at 1,000 mg plus prednisone at 10 mg daily, or placebo and abiraterone acetate plus prednisone daily. (ascopost.com)

Active surveillance includes periodic PSA testing, digital rectal examination (DRE), and prostate biopsy. (medscape.com)
Also, 18 patients with mCRPC underwent biopsy at time of resistance. (figshare.com)

If approved, this will be the first DAT formulation available in the U.S. to patients with mCRPC with BRCA mutations, which are a type of homologous recombination repair (HRR) gene alt. (medworm.com)
Lead study author Fred Saad, MD, FRCS, said that PROpel is the first combination approach to deliver consistent clinical benefits for patients in the first-line mCRPC setting, irrespective of homologous recombination repair (HRR) mutation status. (urologytimes.com)

However, a study published in 2020 found that NSCLC patients with bone metastases who received zoledronic acid every 12 weeks had similar incidences of SREs after one year. (advancedpractitioner.com)

ABT is an orally active acetate salt of the steroidal compound abiraterone with antiandrogen activity[ 3 ]. (ijpsonline.com)

Men with mCRPC were included if they had at least one pharmacy claim for enzalutamide or abiraterone (first claim date = index date) following surgical or medical castration, had no chemotherapy treatment within 12 months prior to the index date, and had continuous VHA enrollment for at least 12 months pre- and post-index date. (statinmed.com)
For patients who develop hepatotoxicity during treatment, hold abiraterone acetate tablets until recovery. (nih.gov)
CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. (nih.gov)
For treatment recommendations for patients with a life expectancy ≥20 y, see initial therapy for Low Risk of Recurrence, below. (medscape.com)
The success of adaptive therapy (AT), whereby treatment is cycled on and off using patient-specific treatment triggers, is hypothesized to be due to the competitive suppression of the resistant population by the sensitive population. (mdpi.com)
There may exist a subset of patients who might benefit from slight modifications to AT, whereby treatment is initially delayed and subsequently cycled to remain between predetermined, patient-specific bounds, i.e., range-bounded adaptive therapy (RBAT). (mdpi.com)
Serious adverse events occurred in 41% of patients in the treatment arm. (medscape.com)
An adverse reaction led to permanent discontinuation of treatment in 15% of patients. (medscape.com)
This designation is an important milestone in our efforts to bring this potentially life-saving drug to patients who are in need of new treatment option. (medworm.com)
Clinical trial design, and eventually clinical practice, needs to focus on using biological phenotype rather than symptoms or number of prior chemotherapeutic regimens as the basis for selecting the proper treatment for a patient. (cancernetwork.com)
The phase 3, randomized, double-blind, placebo-controlled multicenter MAGNITUDE trial evaluated the combination of niraparib and abiraterone plus prednisone in patients with treatment-naive mCRPC with or without certain HRR gene alterations. (onclive.com)
Permanent discontinuation of either study treatment because of an AE occured in 15% of patients. (onclive.com)
Materials and Methods: We retrospectively included mCRPC patients with at least 1 active cardiovascular comorbidity or risk factor according to the European Society of Cardiology (ESC) guidelines and who started treatment with abiraterone acetate from April 2011 to July 2012. (journaltocs.ac.uk)
Pembrolizumab is currently approved by the FDA for use in combination with axitinib (Inlyta) as a frontline treatment for patients with advanced RCC. (urologytimes.com)
The authors explain in their abstract that in patients with localized MIBC, trimodal bladder preservation therapy (TMT), is a standard treatment option. (urologytimes.com)
MRI technology is more costly than CT, both in terms of upfront equipment expenses and longer treatment times, which is one reason our study set out to determine if MRI-guided technology offers tangible benefits for patients. (ecancer.org)
The patient resumes treatment with ADT. (advancedpractitioner.com)
The National Osteoporosis Foundation recommends preventive treatment with a bone-modifying agent (BMA) for patients with osteoporosis or osteopenia and risk factors. (advancedpractitioner.com)
In factoring in the duration of treatment, the type of BMA, and the increased risk of osteonecrosis of the jaw (ONJ) 2 , the patient is given an oral bisphosphonate. (advancedpractitioner.com)
Long-term efficacy and safety of zoledronic acid in the treatment of skeletal metastases in patients with non small cell lung carcinoma and other solid tumors. (advancedpractitioner.com)
The dosage of an Abiraterone Acetate tablet depends upon response to treatment, medical condition, and lab results. (theindianpharma.com)
Patients without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study. (ucsf.edu)
Patients receiving enzalutamide prior to study entry may continue treatment at their current enzalutamide dose level without requirement for wash-out period. (ucsf.edu)
The data from Magnitude supports the significant value of biomarker testing to identify the subgroup of patients most likely to derive a clinical benefit from a targeted treatment and overcome the poor prognosis of mCRPC with BRCA mutations," said Kiran Patel, vice president, clinical development, solid tumors, Janssen research & development, LLC. (outsourcing-pharma.com)
These clinical trials happen after a drug or treatment has been approved for patients to take. (astellas.com)
The Canadian Urological Association (CUA) does not provide professional medical advice, diagnosis or treatment and cannot respond to requests for direct feedback, specific patient information or physician referrals. (cua.org)
Androgen deprivation therapy (ADT), either by medical or surgical castration, is the choice for treatment. (aacc.org)
Change in automated BSI and PSA were obtained from patients who have had bone scan at week 12 of treatment follow-up. (springeropen.com)
Treatment follow-up bone scans were available from 62 patients. (springeropen.com)
If patients progressed, they could receive secondary treatment with abiraterone acetate and prednisone. (medscape.com)

After PSM, each cohort had 1160 patients. (statinmed.com)
0.0001) PPPM outpatient costs compared with the abiraterone cohort. (statinmed.com)
0.0001) were significantly lower in the enzalutamide cohort compared with the abiraterone cohort. (statinmed.com)
The other cohort included patients who did not have HRR gene alterations. (onclive.com)
This is the largest cohort of BRCA1/2-positive patients with mCRPC. (outsourcing-pharma.com)

148-364: "A double-blind, randomised, placebo-controlled, parallel group, multicentre study to assess the efficacy and safety of fixed doses of sildenafil administered for three months to male patients with erectile dysfunction. (barbieriluigi.it)

0001). The 1- and 2-year rPFS rates with olaparib plus abiraterone were 73.8% and 53.7%, respectively. (urologytimes.com)

Patients were not eligible to enroll if they had prior radiotherapy for RCC, or brain or bone metastatic lesions. (urologytimes.com)
Typically, we reserve that therapy for patients with bone-metastatic disease that is symptomatic. (curetoday.com)

Increased fractures and mortality in combination with radium Ra 223 dichloride: Use of abiraterone acetate plus prednisone/prednisolone in combination with radium Ra 223 dichloride is not recommended. (nih.gov)

Mineralocorticoid excess: Closely monitor patients with cardiovascular disease. (nih.gov)
The predominance of patients with metastatic disease in bone has made it difficult to acquire sufficient tissue to perform correlative studies. (cancernetwork.com)
The parallel assignment, double-blind phase 3 KEYNOTE-564 trial (NCT03142334) included patients with renal cell carcinoma (RCC) with a clear cell component who had undergone nephrectomy and had intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED). (urologytimes.com)
We saw the benefits of olaparib in all sub-groups of patients, regardless of country, age, prior therapy and severity of disease, including in those with worse disease that had spread to their liver or lungs," Hussain pointed out. (esmo.org)
Patients must be evaluable for the primary endpoint of composite response, and must have either serum PSA ≥ 2 ng/mL during Screening and/or measurable disease by RECIST 1.1 criteria. (ucsf.edu)
In such patients, the bone scan is the standard imaging modality to assess change in skeletal disease burden. (springeropen.com)

Patients were randomly assigned to receive niraparib or placebo plus abiraterone and prednisone. (onclive.com)
Patients with HRR gene alterations were randomised to receive niraparib 200 mg once daily plus AAP or placebo and AAP. (outsourcing-pharma.com)

Abiraterone Acetate 250mg should be taken orally at about the same time each day, without food. (theindianpharma.com)

Patients also had ongoing androgen deprivation therapy and an ECOG performance status of 0 or 1. (urologytimes.com)
Patients were randomized to the targeted radioligand therapy 177Lu-PSMA-617 (LuPSMA) plus best standard of care (BSC) or BSC alone. (urologytimes.com)
The safety profile of the combined therapy was consistent with the known profile of each monotherapy approved by the FDA, with serious adverse events (AEs) reported in 41% of patients. (pharmaceutical-technology.com)
One challenge that remains with Provenge is determining the patients who are likely to benefit from this therapy. (curetoday.com)
Retrospectively, we included patients who received enzalutamide as a clinically approved therapy for mCRPC and had undergone bone scan prior to starting therapy. (springeropen.com)

In the international, double-blind, phase 3 PROpel trial (NCT03732820), investigators randomized patients with mCRPC in the first-line setting 1:1 to receive olaparib at 300 mg twice daily plus abiraterone at 1000 mg daily (n = 399) or placebo and abiraterone at 1000 mg daily (n = 397). (urologytimes.com)
Additionally, patients either had HRR mutations (27.8% with olaparib vs 29.0% with placebo), non-HRR mutations (69.9% vs 68.8%, respectively), or unknown HRR mutation status (2.3% each). (urologytimes.com)
The median PSA was 17.90 ug/L (interquartile range [IQR], 6.09-67.00) with olaparib/abiraterone and 16.81 ug/L (IQR, 6.26-53.30) with placebo/abiraterone. (urologytimes.com)

If there is no safely accessible metastatic lesion, this requirement will be waived. (ucsf.edu)
With the computer automation, the time of detecting metastatic lesion and calculating the BSI was reduced from an average 20 min (by an experienced reader) to 5 s per patient. (springeropen.com)

Of the 423 patients enrolled, 225 (53%) had prospectively determined BRCA gene mutations. (ascopost.com)
The FDA's approval was based on findings from the phase 3 MAGNITUDE precision medicine study , a randomized, placebo-controlled trial with 423 patients, 225 (53%) of whom had BRCA gene mutations as determined using a tissue assay such as FoundationOne CDx. (medscape.com)
As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation," principal investigator Kim Chi, MD, stated in the Janssen press release . (medscape.com)
95% CI, 0.40-1.12) in BRCA -positive patients who received niraparib plus abiraterone and prednisone vs the placebo-based combination. (onclive.com)
Among patients in the MAGNITUDE study with a BRCA gene alteration, 41% experienced a serious adverse effect with the investigational regimen. (onclive.com)
In Magnitude, a total of 423 patients with HRR gene alterations were enrolled, 225 (53.2%) of whom had BRCA mutations. (outsourcing-pharma.com)

However, there is still a subset of patients across all of these cancers who do not respond to immunotherapy. (curetoday.com)

The chromatographic separation of abiraterone acetate and its major degradation product is achieved on Capcell PAK C 18 MG-III (100×4.6 mm, 3 μm) column using combination of 0.1 % acetic acid and acetonitrile as mobile phase with a flow rate of 1.2 ml/min and the wavelength of detection is selected as 251 nm. (ijpsonline.com)
However, while our knowledge of biology has enabled us to design more specific treatments, patients are still entered in phase III trials based on clinical rather than molecular parameters. (cancernetwork.com)

Abiraterone acetate tablets must be taken as a single dose once daily on an empty stomach. (nih.gov)
For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the abiraterone acetate tablets starting dose to 250 mg once daily. (nih.gov)
Monitor blood glucose in patients with diabetes and assess if antidiabetic agent dose modifications are required. (nih.gov)

The investigators hypothesize that the combination of FOR46 plus enzalutamide will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients. (ucsf.edu)
Eighty mCRPC patients with baseline bone scans were included in the study. (springeropen.com)
The upgraded and analytically validated automated BSI was found to be a strong predictor of OS in mCRPC patients. (springeropen.com)
Additionally, the change in automated BSI demonstrated an additive clinical value to the change in PSA in mCRPC patients being treated with enzalutamide. (springeropen.com)

Abiraterone Acetate works by blocking the production of Testosterone and results in slowing down the spread and growth of cancerous tissue. (theindianpharma.com)

The median age of the patients was 69 years (IQR, 63-73.5), 79% had bone metastases, 55% had lymph node metastases, and 17% had visceral metastases. (ru.nl)

Objective To systematically review contemporary data regarding HRQOL outcomes in patients with advanced PCa. (isidl.com)

These highlights do not include all the information needed to use ABIRATERONE ACETATE TABLETS safely and effectively. (nih.gov)
See full prescribing information for ABIRATERONE ACETATE TABLETS. (nih.gov)
Patients receiving abiraterone acetate tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. (nih.gov)
Do not eat food 2 hours before and 1 hour after taking abiraterone acetate tablets. (nih.gov)
Abiraterone acetate tablets should be discontinued if patients develop severe hepatotoxicity. (nih.gov)
Abiraterone acetate tablets should be swallowed whole with water. (theindianpharma.com)
Storage and Handling of medicine Abirapro Store the medicine at room temperature between 68°F-77°F (20°C-25°C). Abiraterone acetate tablets should be kept out of sight and reach of children. (theindianpharma.com)

To determine the objective response rate by RECIST 1.1 criteria among patients with measurable soft tissue by RECIST 1.1 criteria at baseline. (ucsf.edu)

Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy. (medscape.com)
All patients received a GnRH analog or had prior bilateral orchiectomy. (zytigahcp.com)

Enzalutamide-treated men with chemotherapy-naïve mCRPC had significantly lower resource utilization and healthcare costs compared with abiraterone-treated men. (statinmed.com)

Anatomy3

Diseases7

Chemicals and Drugs23

Analytical, Diagnostic and Therapeutic Techniques and Equipment4

Phenomena and Processes2

Health Care3

Cancer193

ZYTIGA3

Inhibitor7

Docetaxel8

Antigen5

CRPC4

Niraparib and abiraterone acetate plus prednisone3

Radiographic progression-free sur5

Apalutamide6

Safety of abiraterone acetate1

Progression5

Survival9

Akeega2

Toxicity3

Tumor4

Inhibitors2

Enzalutamide in patients1

Abirapro is Abiraterone1

1,000 mg2

Biopsy2

Homologous recombination repair2

20201

Steroidal compound1

Treatment30

Cohort5

Efficacy1

RPFS1

Bone metastatic2

Prednisolone1

Disease6

Receive niraparib2

Taken orally1

Therapy5

Olaparib3

Lesion2

BRCA6

Cancers1

Phase2

Dose3

MCRPC patients4

Testosterone1

Median1

Outcomes in patients1

Tablets7

Measurable soft tissue1

Bilateral2

Significantly1