Clinical trial · Interventional
Abiraterone Acetate in Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
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
NCT00638690CI-TRIAL-00014386completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate | Drug | Abiraterone Acetate | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Prednisone/prednisolone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abiraterone acetate plus prednisone/prednisolone
- interventionNames
- Drug: Abiraterone acetate
- Drug: Prednisone/prednisolone
- type
- PLACEBO_COMPARATOR
- label
- Placebo plus prednisone/prednisolone
- interventionNames
- Drug: Placebo
- Drug: Prednisone/prednisolone
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- Up to 60 months
- description
- Overall survival is defined as the time interval from the date of randomization to the date of death from any cause.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic Castration-Resistant Prostate Cancer Progression after one or two prior cytotoxic chemotherapies * At least one chemotherapy must have contained docetaxel * Eastern Cooperative Oncology Group (ECOG) Performance Status \<= 2 * Medical or surgical castration with testosterone \< 50 ng/dL * Adequate bone marrow, hepatic and renal function * Potassium \>= 3.5 mmol/L * Able to swallow the study drug whole as a tablet * Informed Consent Exclusion Criteria: * More than two prior cytotoxic chemotherapy regimens * Prior Ketoconazole for prostate cancer * Prior abiraterone acetate or other CYP17 inhibitor or investigational agents targeting the androgen receptor for prostate cancer * Uncontrolled hypertension * Active or symptomatic viral hepatitis or chronic liver disease * History of pituitary or adrenal dysfunction * Clinically significant heart disease * Other malignancy * Known brain metastasis * GI disorder affecting absorption * Not willing to use contraception
References
Publications (13)
- DERIVEDZhao J, Cai X, Mo Z, Zhao D, Wang J, Yang Z, Long X, Li Y, Chen D, Li J, Zhou Z, Li S, Li Y. Association between concomitant ACEI/ARBs use and survival of patients with prostate cancer receiving abiraterone acetate: A post-hoc analysis of two randomized trials. Prostate Cancer Prostatic Dis. 2026 Jun 12. doi: 10.1038/s41391-026-01128-1. Online ahead of print. PMID 42286315
- DERIVEDHeller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22. PMID 29272162
- DERIVEDChi KN, Kheoh T, Ryan CJ, Molina A, Bellmunt J, Vogelzang NJ, Rathkopf DE, Fizazi K, Kantoff PW, Li J, Azad AA, Eigl BJ, Heng DY, Joshua AM, de Bono JS, Scher HI. A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel. Ann Oncol. 2016 Mar;27(3):454-60. doi: 10.1093/annonc/mdv594. Epub 2015 Dec 18. PMID 26685010
- DERIVEDFizazi K, Flaig TW, Stockle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25. PMID 26609008
- DERIVEDAntoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.