NCT02405858

A Study of Abiraterone Acetate in Metastatic Castration-Resistant Prostate Cancer Participants Who Responded Poorly to the First-line Combined Androgen Blockade Therapy

A Phase 4 Study of Zytiga in Poor-risk mCRPC (Metastatic Castration-Resistant Prostate Cancer) Patients Who Was Failed the First-line CAB (Combined Androgen Blockade) Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the percentage of participants achieving prostate-specific antigen (PSA) response by 12 weeks of therapy from baseline according to Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.

Detailed description

This is a Phase 4, non-randomized, multi-center (when more than one hospital work on a medical research study), open label (identity of study drug will be known to participant and study staff), single arm study of abiraterone acetate to investigate its efficacy and safety in participants with metastatic castration-resistant prostate cancer (mCRPC) who failed the first-line combined androgen blockade (CAB) therapy. The study consists of Screening Phase (28 days prior to Cycle 1 Day 1), Treatment Phase (up to 2 years), Post Treatment Phase (30 days after the last dose of study drug). Participants will receive 1000 milligram (mg) (four 250 mg tablets) of abiraterone acetate orally once daily. In addition, 5 mg of oral prednisolone will be concomitantly administered twice a day (10 mg per day). A 28-daily dosing cycle will be continued until disease progression or unacceptable toxicity is observed. The total duration of study will be 2 years. Participants will be primarily evaluated for PSA response. Participants' safety will be monitored throughout the study.

Conditions

• Metastatic Castration-Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Abiraterone Acetate	Abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily up to Cycle 26.
DRUG	Prednisolone	Oral prednisolone 5 mg will be concomitantly administered twice a day (10 mg/day) up to Cycle 26.

Timeline

• Start date: 2015-04-10
• Primary completion: 2017-12-31
• Completion: 2017-12-31
• First posted: 2015-04-01
• Last updated: 2025-02-03

Locations

14 sites across 1 country: Japan