Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy

• Status: Completed
• Trial end date: 2018-10-26
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the efficacy, based on prostate-specific antigen (PSA) progression, of abiraterone acetate in participants with metastatic (spread of cancer cells from one part of the body to another) castration (any action, surgical, chemical, or otherwise, by which a male loses the functions of the testes) resistant prostate cancer (cancer in prostrate; a gland that makes fluid that aids movement of sperm) (mCRPC), chemo-naive (treatment of cancer is not done using drugs), who received a prior diethylstilbestrol therapy (DES).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Abiraterone Acetate; Androgens; Diethylstilbestrol; Fosfestrol; Prednisone

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology

• Prior therapy with diethylstilbestrol (DES) for castration resistant prostate cancer. Participants should demonstrate evidence of progression on DES or evidence of grades 3/4 toxicities on DES

• Metastatic disease documented by positive bone scan or metastatic lesions on computerized tomography (CT) or magnetic resonance imaging (MRI)

• May have received prior androgen blockage (bicalutamide or flutamide) but must have been discontinued for least 28 days

• Ongoing androgen deprivation therapy (ADT) (luteinizing hormone-releasing hormone [LHRH] agonist or orchiectomy), with serum testosterone level of less than 50 nanogram per deciliter (1.7 nanomole per liter) and eligible participants must maintain ADT

Exclusion Criteria:

• Active infection or other medical condition that would make prednisone use contraindicated

• Any chronic medical condition requiring a higher systemic dose of corticosteroid than 5 milligram (mg) prednisone per day

• Pathological finding consistent with small cell carcinoma of the prostate

• Known brain metastasis

• Has had prior cytotoxic chemotherapy or biologic therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC)