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

NCT ID: NCT00485303

Last Updated: 2013-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2011-10-31

Brief 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).

Detailed 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.

Conditions

Prostatic Neoplasms; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Abiraterone

Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) will be administered once daily along with 5 mg oral prednisolone tablet administered twice daily for 28-days dosing cycle and will be continued until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

Abiraterone acetate

Intervention Type: DRUG

Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.

Prednisone

Intervention Type: DRUG

Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.

Interventions

Abiraterone acetate

Abiraterone acetate oral tablets 250 milligram (mg) each will be administered at a total dose of 1000 mg until documented disease progression or unacceptable toxicity.

Intervention Type: DRUG

Prednisone

Prednisone/Prednisolone 5 mg tablet will be taken orally twice daily.

Intervention Type: DRUG

Other Intervention Names

CB7630

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Cougar Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cougar Biotechnology, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Cougar Biotechnology, Inc.

Locations

UCLA

Los Angeles, California, United States

Los Angeles, California, United States

UCSF Comprehensive Cancer Center

San Francisco, California, United States

San Francisco, California, United States

John Hopkins

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Masachussetts General Hospital Cancer Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Hospital

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

New York, New York, United States

Royal Marsden Hospital

Sutton, , United Kingdom

Sutton, , United Kingdom

Countries

United States; United Kingdom

References

Danila DC, Anand A, Sung CC, Heller G, Leversha MA, Cao L, Lilja H, Molina A, Sawyers CL, Fleisher M, Scher HI. TMPRSS2-ERG status in circulating tumor cells as a predictive biomarker of sensitivity in castration-resistant prostate cancer patients treated with abiraterone acetate. Eur Urol. 2011 Nov;60(5):897-904. doi: 10.1016/j.eururo.2011.07.011. Epub 2011 Jul 14.

Reference Type: DERIVED

PMID: 21802835 (View on PubMed)

Related Links

http://www.cancer.gov/

NATIONAL CANCER INSTITUTE

http://www.nlm.nih.gov/medlineplus/prostatecancer.html

PROSTATE CANCER

Other Identifiers

COU-AA-004

Identifier Type: -

Identifier Source: secondary_id

2007-002725-74

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR016921

Identifier Type: -

Identifier Source: org_study_id