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Trial Information
Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaCancers and Other NeoplasmsEnrollment1195% FemaleN/A% White93%
Product ClassHormonesSponsor Protocol NumberCOU-AA-301Data PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)69
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0392 : Missing data considerations for patient reported outcome measures in randomized controlled trials
- 2024-0372 : Development of a clinical decision-support algorithm based on Network Meta-Analysis and Decision Curve Analysis for patients with metastatic castration-resistant prostate cancer (mCRPC)
- 2024-0360 : The effect of ACEi/ARB on survival outcome of metastatic prostate cancer patients treated with Abiraterone acetate (AA)
- 2024-0060 : Using Synthetic Controls to Improve Randomised Controlled Trials for Rare Diseases
- 2023-5290 : The Impact of Dose Timing on the Efficacy and Safety of Abiraterone Acetate plus Prednisone in Men with Advanced Prostate Cancer
- 2023-5236 : Understanding the Symptom Experience of Abiraterone and the Effect on Quality of Life for Men with metastatic Prostate Cancer.
- 2023-5198 : Evaluation of G-computation and conformal prediction to provide early signs of efficacy in single arm trial with time to event outcomes
- 2023-5195 : Predictive modeling of adverse events and symptoms patterns in large scale clinical trials
- 2023-5187 : The association between antibiotics exposure and outcomes in men with prostate cancer
- 2023-5173 : Improving Outcome in Advanced Prostate Cancer: a Pooled Analysis of Randomized Controlled Trials
- 2022-5125 : Risk of therapy-related adverse events in men on abiraterone or enzalutamide, a meta-analysis of clinical trial data
- 2022-5106 : Assessing the Androgen indifferent prostate cancer patients response to novel antiandrogen-based regimen or taxanes
- 2022-5039 : An evaluation of the performance of two population-adjusted indirect comparison methods in anchored and unanchored settings
- 2022-5030 : Overall Survival and Radiographic Progression Free Survival difference among Asian, White and Black mCRPC patients treated with Abiraterone
- 2022-5027 : Development of a prognostic calculator for patients with metastatic prostate cancer undergoing treatment with androgen receptor axis-targeted therapy.
- 2022-4977 : Clinical Trials dataset for teaching purposes at University College London
- 2022-4974 : Association between adverse events and change in quality-of-life scores in phase II-III cancer clinical trials
- 2022-4889 : Summarising the therapeutic and adverse effects of anticancer medicines according to race and sex: pooled analysis of clinical trials
- 2021-4841 : The Impact of Second Generation Anti-Androgens on Quality of Life in Men with Advanced Prostate Cancer
- 2021-4813 : Association between proton pump inhibitor use and survival of patients with prostate cancer receiving abiraterone acetate plus prednisone
- 2021-4777 : Adverse Events of Special Interest (AESI) Predict Response to Abiraterone Acetate (AA): A Retrospective Analysis
- 2021-4740 : The Impact of Second Generation Anti-Androgens on Sexual Function in Men with Advanced Prostate Cancer
- 2021-4649 : A statistical methodology study to evaluate External Comparator Arm study results versus Randomized Controlled Trials in cancer drug development
- 2020-4453 : Data-Adaptive Weighting of Real-World and Randomized Controls Using Propensity Scores: Creating a Hybrid Control Arm
- 2020-4410 : Predictors of therapeutic and adverse effects of medicines used in the treatment of prostate cancer
- 2020-4189 : Design and validation of an external control arm using prior clinical trials and real-world data
- 2019-4090 : Association of Health Related Quality of Life variations with biological biomarkers for patients with metastatic castrate resistant prostate cancer
- 2019-3999 : Psychiatric Symptoms as Adverse Events of Abiraterone / Prednisolone Therapy: Systematic Review and Meta-Analysis
- 2019-3936 : Unbiased Treatment Efficacy Detection Methods with Patient Centered Outcomes
- 2018-3745 : Association of Quality of Life Measures with Outcome in Metastatic Castration-resistant Prostate Cancer
- 2018-3011 : Clinical Significance and Factors Associated with PSA Progression in mCRPC Patients Treated with Abiraterone
- 2018-2801 : Development and applications of new safety analysis methods for randomized clinical trials
- 2018-2686 : Exploring the impact of different analysis and extrapolation methods for time-to-event data on estimates of lifetime cost-effectiveness.
- 2017-2651 : Do alpha blockers and 5-reductase inhibitors influence survival and urinary function in patients with castration resistant prostate cancer
- 2017-2036 : Determine the growth and regression rate constant and the fractional cell kill of abiraterone acetate in prostate cancer
- 2017-1861 : TESTING - Ginger
- 2017-1356 : Does Body Mass Index predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer?
- 2016-1136 : Impact of statins on outcomes in patients with castration resistant prostate cancer treated with abiraterone
- 2016-1103 : The neutrophil to leukocyte ratio (NLR) in metastatic castrate resistant prostate cancer(mCRPC) patients treated with abiraterone acetate
- 2016-1058 : Predictors of survival in metastatic castration-resistant prostate cancer
- 2016-1057 : Incidence of visceral metastasis at time of progression on abiraterone for metastatic castration-resistant prostate cancer
- 2016-0979 : Predictors of radiographic progression in metastatic castration-resistant prostate cancer: Retrospective analysis of COU-AA-301
- 2015-0565 : Understanding reasons for screen failures in late phase trials in advanced GU cancers
- 2015-0500 : Studying the Risk of Harmful Drug-Drug Interactions (DDI) in Patients with Castration-Resistant Prostate Cancer (CRPC) Treated with Abiraterone (ABI)
- 2015-0406 : Is primary tumor in prostate cancer a reliable target lesion (measurable disease) at contrast-enhanced (CE) CT.
- 2014-0333 : RECIST response as a surrogate endpoint in metastatic castration-resistant prostate cancer: Retrospective analysis of COU-AA-302 and COU-AA-301