Clinical trial · Interventional
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone in Participants With Prostate Cancer
A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration Resistant Prostate Cancer Patients Who Are Chemotherapy-Naïve
NCT01756638CI-TRIAL-00030003completedPhase 2ClinicalTrials.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 investigate safety and efficacy of abiraterone in participants with metastatic castration-resistant prostate cancer (mCRPC) and who have not received prior chemotherapy (treatment of disease, usually cancer, by chemical agents).
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 | Drug | Abiraterone | ALIAS |
| Prednisolone | Drug | Prednisolone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abiraterone plus Prednisolone
- description
- Abiraterone 1000 milligram (mg) oral tablets will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-daily dosing cycles and will be continued until disease progression or unacceptable toxicity.
- interventionNames
- Drug: Abiraterone
- Drug: Prednisolone
Primary outcomes (1)
- measure
- Percentage of participants achieving Prostate-Specific Antigen (PSA) response up to 12 weeks
- timeFrame
- Baseline up to 12 weeks
- description
- The PSA response will be evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline up to 12 weeks after the first dose of study drug, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA.
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * In-patients or out-patients with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology * Have surgically or medically castrated, with testosterone levels of less than 50 nanogram per deciliter * Have prostate-specific antigen (PSA) level of at least 5 nanogram per milliliter * Be under PSA progression according to Prostate-Specific Antigen Working Group (PSAWG) eligibility criteria or objective progression by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 criteria for participants with measurable disease after androgen deprivation * Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 Exclusion Criteria: * Has received other hormonal therapy, including any dose of finasteride, dutasteride, any herbal product known to decrease PSA levels or any systemic corticosteroid within 4 weeks prior to Cycle 1 Day 1 or has received ketoconazole for prostate cancer * Has received radiotherapy, chemotherapy (including estramustine) or immunotherapy (including provenge) within 4 weeks, or single fraction of palliative radiotherapy within 2 weeks prior to Cycle 1 Day 1 * Has had surgery or local prostatic intervention within 4 weeks prior to Cycle 1 Day 1. In addition, any clinically relevant sequel from the surgery must have resolved prior to Cycle 1 Day 1 * Has clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events, severe or unstable angina, or New York Heart Association (NYHA) Class 3 to 4 heart disease or cardiac ejection fraction measurement of less than 50 percent within 6 months prior to Cycle 1 Day 1 * Has uncontrolled hypertension (systolic blood pressure greater than or equal to 160 millimeter of mercury or diastolic blood pressure greater than or equal to 95 millimeter of mercury)
References
Publications (1)
- DERIVEDMatsubara N, Uemura H, Satoh T, Suzuki H, Nishiyama T, Uemura H, Hashine K, Imanaka K, Ozono S, Akaza H. A phase 2 trial of abiraterone acetate in Japanese men with metastatic castration-resistant prostate cancer and without prior chemotherapy (JPN-201 study). Jpn J Clin Oncol. 2014 Dec;44(12):1216-26. doi: 10.1093/jjco/hyu149. Epub 2014 Oct 15. PMID 25320340