Clinical trial · Interventional
Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer
A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
NCT01591122CI-TRIAL-00042884completedPhase 3ClinicalTrials.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)
The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone acetate and prednisone | Drug | — | UNRESOLVED |
| Placebo and prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abiraterone acetate and prednisone
- interventionNames
- Drug: Abiraterone acetate and prednisone
- type
- ACTIVE_COMPARATOR
- label
- Placebo and prednisone
- interventionNames
- Drug: Placebo and prednisone
Primary outcomes (1)
- measure
- Time to prostate specific antigen (PSA) progression (TTPP)
- timeFrame
- 14 months
- description
- Measured from the time interval from the date of randomization to the date of the PSA progression based on prostate cancer clinical trials working group 2 (PCWG2) criteria
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease * Prostate cancer progression documented by PSA progression or radiographic progression * Asymptomatic or mildly symptomatic from prostate cancer * Surgically or medically castrated, with testosterone levels of \<50 ng/dL * Previous anti-androgen therapy and progression after withdrawal * ECOG performance status score of 0 or 1 * If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1 * If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1 * If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days * Life expectancy of at least 6 months Exclusion Criteria: * Active infection or other medical condition that would make prednisone (corticosteroid) use contraindicated * Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily * Pathological finding consistent with small cell carcinoma of the prostate * Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months * Prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) * Radiation or radionuclide therapy for treatment of mCRPC * Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment * History of pituitary or adrenal dysfunction
References
Publications (0)
Data not yet available
No reference posted for this study.