Clinical trial · Interventional
A Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer
A Phase 2 Open Label Study of Abiraterone Acetate (JNJ-212082) and Prednisolone in Patients With Advanced Prostate Cancer Who Have Failed Androgen Deprivation and Docetaxel-Based Chemotherapy.
NCT01685983CI-TRIAL-00037619completedPhase 2Results 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)
The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.
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 | Drug | Abiraterone Acetate | ALIAS |
| Prednisolone | Drug | Prednisolone | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abiraterone actetate and Prednisolone
- interventionNames
- Drug: Abiraterone acetate
- Drug: Prednisolone
Primary outcomes (1)
- measure
- Percentage of Participants With Prostate-specific Antigen (PSA) Response
- timeFrame
- Baseline, Month 4
- description
- The PSA response was evaluated according to Prostate-Specific Antigen Working Group (PSAWG) criterion, which is, greater than or equal to 50 percent decrease in PSA from Baseline during the study, which would be subsequently confirmed by a measurement that is at least 4 or more weeks after initial documentation of PSA response.
Secondary outcomes (6)
- measure
- Overall Survival
- timeFrame
- Up to 3 Years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate (stage IV) * Has documented Prostate Specific Antigen (PSA) progression according to protocol-specific prostate specific antigen working group (PSAWG) eligibility criteria * Has undergone prior chemotherapy for prostate cancer with regimen(s) containing Docetaxel * Has an ongoing androgen deprivation with serum testosterone less than 50 ng/dL * Has not received radiotherapy, chemotherapy, or immunotherapy at least 30 days prior to the treatment * Eastern Cooperative Oncology Group Performance Status less than or equal to 2 Exclusion Criteria: * Active or uncontrolled autoimmune disease that may require corticosteroid therapy * Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection * Uncontrolled hypertension * Hemoglobin less than or equal to 9.0 g/dL independent of transfusion * Has abnormal liver function tests * Surgery or local prostatic intervention within 30 days of the first dose
References
Publications (0)
Data not yet available
No reference posted for this study.