Study of Abiraterone Acetate Plus Prednisone in Patients With Chemo-naive Metastatic Castration-Resistant Prostate Cancer

• Status: Completed
• Trial end date: 2019-01-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to demonstrate the safety and effectiveness of abiraterone acetate when co-administered with prednisone in patients with chemo-naive metastatic castration resistant prostate Cancer (mCRPC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Has a confirmed diagnosis of adenocarcinoma of the prostate with evidence of metastatic disease

• Prostate cancer progression documented by PSA progression or radiographic progression

• Asymptomatic or mildly symptomatic from prostate cancer

• Surgically or medically castrated, with testosterone levels of <50 ng/dL

• Previous anti-androgen therapy and progression after withdrawal

• ECOG performance status score of 0 or 1

• If opiate analgesics for cancer-related pain, treatment must not be administered within 4 weeks of Cycle 1 Day 1

• If radiation therapy for treatment of the primary tumor is given, treatment must not be administered within 6 weeks of Cycle 1 Day 1

• If previously treated with ketoconazole for prostate cancer, duration of treatment must not be greater than 7 days

• Life expectancy of at least 6 months

Exclusion Criteria:

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

• Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone twice daily

• Pathological finding consistent with small cell carcinoma of the prostate

• Liver or visceral organ metastasis, brain metastasis, and other malignancy, except non-melanoma skin cancer, with a 30% probability of recurrence within 24 months

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

• Radiation or radionuclide therapy for treatment of mCRPC

• Uncontrolled hypertension, patients with a history of hypertension are allowed provided blood pressure is controlled by anti hypertensive treatment

• History of pituitary or adrenal dysfunction