Neoadjuvant Abiraterone Acetate Plus Leuprolide Acetate in Men With Localized High Risk Prostate Cancer

Condition(s) targeted: Prostate Cancer

Intervention: abiraterone acetate plus leuprolide acetate plus prednisone (Drug); leuprolide acetate (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Cougar Biotechnology, Inc.

Official(s) and/or principal investigator(s):
Chris Haqq, MD, PhD, Study Director, Affiliation: Cougar Biotechnology, Inc.

The purpose of this research study is to determine the effects of abiraterone acetate plus leuprolide acetate and prednisone versus leuprolide acetate alone on hormone levels in the blood and prostate. For this study, patients are required to be suitable candidates for a radical prostatectomy (prostate surgery) which will be performed after 24 weeks of treatment.

Official title: A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To compare serum and prostate tissue androgen levels

Secondary outcome:

Pathologic complete response rate at prostatectomy

Prostate specific antigen response rate

Tumor expression of AR regulated genes

Molecular correlates

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

1. Histologically or cytologically confirmed adenocarcinoma of the prostate

2. At least three core biopsies positive for prostate cancer

3. At least one of the following features:

- PSA >10 ng/ml

- PSA velocity > 2 ng/ml/year (defined as a rise in PSA of > 2 ng/ml in the

preceding12 month period)

- Gleason score ≥ 7 (4+3)

- Gleason score 6 if either PSA ≥ 10 ng/ml or PSA velocity ≥ 2 ng/ml/year

4. Serum testosterone > 200 ng/dL

5. Patient and urologist must agree that patient is suitable for prostatectomy

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

Exclusion Criteria:

1. Serious or uncontrolled co-existent, non-malignant disease, including active and uncontrolled infection

2. Abnormal liver function

3. Uncontrolled hypertension

4. Clinically significant heart disease

5. Other active malignancy

6. History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug

7. Prior therapy with abiraterone acetate

8. Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study

9. Gleason score ≤ 5 (total)

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States; Recruiting
David Flanagan, Phone: 617-632-3237
Judith Prisby, RN, Phone: 617-582-8313
Mary-Ellen Taplin, MD, Principal Investigator

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Mary Ellen Morrissey, RN, Phone: 617-667-9187, Email: mmorris1@bidmc.harvard.edu
Stephen Duggan, Phone: 617-632-9281
Glenn Bubley, MD, Principal Investigator

Roswell Park Cancer Institute, Buffalo, New York 14263, United States; Not yet recruiting
James Mohler, MD, Phone: 716-845-8433, Email: james.mohler@roswellpark.org
James Mohler, MD, Principal Investigator

The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Christopher Logothetis, MD, Phone: 713-792-2830
Christopher Logothetis, MD, Principal Investigator

University of Washington, Seattle, Washington 98109, United States; Recruiting
Christine Wallace, Phone: 206-288-7023, Email: wallacec@seattlecca.org
Tove Thompson, Phone: 206-288-12323, Email: tovethom@seattlecca.org
Bruce Montgomery, MD, Principal Investigator

Wenatchee Valley Medical Center, Wenatchee, Washington 98801, United States; Recruiting
Sharon Neace, Phone: 509-665-5800
Lori VanLith, CMA, CRC, Phone: 509-665-5800
Mitchell Garrison, MD, Principal Investigator

COUGAR BIOTECHNOLOGY, INC.

AMERICAN SOCIETY OF CLINICAL ONCOLOGY

NATIONAL CANCER INSTITUTE

NATIONAL INSTITUTE OF HEALTH

Starting date: September 2009
Last updated: March 2, 2010