- CSR Summary Not Available
- NCT02236637
- Primary Citation
Trial Information
Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaCancers and Other NeoplasmsEnrollment3049% FemaleN/A% WhiteN/A
Product ClassHormonesSponsor Protocol Number212082PCR4001Data PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)N/A
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
Approved Data Requests Associated with this Trial
- 2024-0220 : Real-World Patient-Reported Outcomes and Tolerability in MCRPC
- 2024-0060 : Using Synthetic Controls to Improve Randomised Controlled Trials for Rare Diseases
- 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
- 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
- 2022-5027 : Development of a prognostic calculator for patients with metastatic prostate cancer undergoing treatment with androgen receptor axis-targeted therapy.
- 2021-4740 : The Impact of Second Generation Anti-Androgens on Sexual Function in Men with Advanced Prostate Cancer
- 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
- 2020-4359 : Testing The Impact Of Enzalutamide And Abiraterone On Overall Survival In Patients With Metastatic Castration-Resistant Prostate Cancer
- 2020-4189 : Design and validation of an external control arm using prior clinical trials and real-world data
- 2019-3999 : Psychiatric Symptoms as Adverse Events of Abiraterone / Prednisolone Therapy: Systematic Review and Meta-Analysis