Clinical trial · Interventional
A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer
A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer
NCT00924469CI-TRIAL-00010069completedPhase 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 evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery to remove all or part of the prostate gland).
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone | Drug | Abiraterone | ALIAS |
| Leuprolide | Drug | Leuprolide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abiraterone plus leuprolide plus prednisone
- description
- Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks.
- interventionNames
- Drug: Abiraterone
- Drug: Leuprolide
- Drug: Prednisone
- type
- ACTIVE_COMPARATOR
- label
- Leuprolide then abiraterone plus leuprolide plus prednisone
- description
- Leuprolide acetate will be administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day with prednisone tablets administered orally as 5 mg once daily.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate * At least three core biopsies positive for prostate cancer (a minimum of 6 core biopsies must be obtained at baseline). A prostate biopsy within 6 months from Screening is allowed for entry requirements * At least one of the following features: prostate specific antigen (PSA) greater than (\>) 10 nanogram per milliliter (ng/ml); PSA velocity \>2 ng/ml per /year (defined as a rise in PSA of \>2 ng/ml in the preceding 12 month period); Gleason score greater than or equal to (\>=) 7 (4+3); Gleason score 6 if either PSA \>=10 ng/ml or PSA velocity \>=2 ng/ml/year * Serum testosterone \>200 nanogram/deciliter * Participant and urologist must agree that participant is suitable for prostatectomy Exclusion Criteria: * Serious or uncontrolled co-existent, non-malignant disease, including active and uncontrolled infection * Abnormal liver function consisting of any of the following: serum bilirubin \>= 1.5 \* upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase \>=2.5 \* ULN * Uncontrolled hypertension within the Screening period (systolic blood pressure \>= 160 millimeter of mercury \[mmHg\] or diastolic BP \>= 95 mmHg) * Requirement for corticosteroids greater than the equivalent of 5 milligram of prednisone daily * Participants with active or symptomatic viral hepatitis or chronic liver disease or clinically significant heart disease or as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50 percent at Baseline or history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
References
Publications (0)
Data not yet available
No reference posted for this study.