Prostate Cancer Clinical Trial

An Efficacy and Safety Study of Abiraterone Acetate and Prednisone in Participants With Prostate Cancer Who Failed Androgen Deprivation and Docetaxel-Based Chemotherapy

Summary

The purpose of this study is to evaluate the efficacy and safety of abiraterone acetate in participants with advanced prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors).

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Full Description

This is an open-label (all people know the identity of the intervention), single-arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the anti-tumor activities and safety of abiraterone acetate in participants with prostate cancer who have failed androgen deprivation and docetaxel-based chemotherapy. Abiraterone acetate oral tablet will be administered as a total dose of 1000 milligram (mg) orally (by mouth) once daily after an overnight fast and prednisone/prednisolone will be administered as 5 mg oral tablet twice daily. Participants will be enrolled and treated up to 12 cycles (or longer, if they have not progressed and continue to benefit from treatment). The study will consist of 3 parts: Screening (14 days), Open-label Treatment; and follow-up (up to 60 months). Participants will be evaluated primarily for prostate specific antigen response according to Prostate Specific Antigen Working Group (PSAWG) criteria. Participants' safety will be monitored throughout the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma (malignant epithelial tumor with a glandular organization)of the prostate (a gland in the male reproductive system found below the bladder and in front of the rectum), but not with neuroendocrine (specialized neurons that produce hormones, such as neuropeptides or biogenic amines) differentiation or of small cell histology
Prior chemotherapy (treatment of disease, usually cancer, by chemical agents) for prostate cancer with regimen(s) containing docetaxel
Documented prostate specific antigen (PSA) progression according to Prostate Specific Antigen Working Group (PSAWG) eligibility criteria with a PSA more than (>) 5 nanogram per milliliter (ng/mL) or objective progression by Response Evaluation Criteria in Solid Tumors (RESIST) criteria
Ongoing androgen deprivation with serum testosterone less than (<) 50 nanogram per deciliter (ng/dL)
Eastern Cooperative Oncology Group (ECOG) Performance Status of less than equal to (<=) 2 (Karnofsky Performance Status >= 50 percent)

Exclusion Criteria:

Active or uncontrolled autoimmune disease (disorder in which a person's immune system attacks parts of his or her own body) that may require corticosteroid therapy
Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Uncontrolled hypertension (high blood pressure)
Hemoglobin <=9.0 gram per deciliter (g/dL) without growth factor or transfusion support
Abnormal liver (large organ that helps in many body functions, including digestion, metabolism, and storage of substances) function

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT00485303

Recruitment Status:

Completed

Sponsor:

Cougar Biotechnology, Inc.

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There are 7 Locations for this study

See Locations Near You

UCLA
Los Angeles California, 90024, United States

Los Angeles California, , United States
UCSF Comprehensive Cancer Center
San Francisco California, 94115, United States

San Francisco California, , United States
John Hopkins
Baltimore Maryland, 21205, United States

Baltimore Maryland, , United States
Masachussetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02115, United States
Beth Israel Hospital
Boston Massachusetts, 02215, United States

Boston Massachusetts, , United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States

New York New York, , United States
Royal Marsden Hospital
Sutton , , United Kingdom

Sutton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

58

Study ID:

NCT00485303

Recruitment Status:

Completed

Sponsor:


Cougar Biotechnology, Inc.

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