- CSR Summary Not Yet Available
- NCT01695135
- Primary Citation
- Data Specification Not Available
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Trial Information
Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaCancers and Other NeoplasmsEnrollment214% FemaleN/A% WhiteN/A
Product ClassHormonesSponsor Protocol NumberABI-PRO-3001Data PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)68
Supporting Documentation
- Collected Datasets Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0424 : Evaluation of Bellmunt Risk Score as a prognostic score in metastatic castration-resistant prostate cancer
- 2023-5236 : Understanding the Symptom Experience of Abiraterone and the Effect on Quality of Life for Men with metastatic Prostate Cancer.
- 2023-5215 : Analysis of adverse events of prostate cancer drugs targeting on the hypothalamic pituitary gonadal axis
- 2023-5198 : Evaluation of G-computation and conformal prediction to provide early signs of efficacy in single arm trial with time to event outcomes
- 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
- 2022-5030 : Overall Survival and Radiographic Progression Free Survival difference among Asian, White and Black mCRPC patients treated with Abiraterone
- 2022-4974 : Association between adverse events and change in quality-of-life scores in phase II-III cancer clinical trials
- 2021-4841 : The Impact of Second Generation Anti-Androgens on Quality of Life in Men with Advanced Prostate Cancer
- 2021-4740 : The Impact of Second Generation Anti-Androgens on Sexual Function in Men with Advanced Prostate Cancer
- 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
- 2019-3999 : Psychiatric Symptoms as Adverse Events of Abiraterone / Prednisolone Therapy: Systematic Review and Meta-Analysis