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| Sponsor: | Cougar Biotechnology, Inc. |
|---|---|
| Information provided by: | Cougar Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT00924469 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: abiraterone acetate plus leuprolide acetate plus prednisone Drug: leuprolide acetate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 58 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
abiraterone acetate plus leuprolide acetate plus prednisone
|
Drug: abiraterone acetate plus leuprolide acetate plus prednisone
abiraterone acetate (1000 mg daily) plus prednisone (5 mg daily) plus leuprolide acetate (22.5 mg every 12 weeks)
|
|
2: Active Comparator
leuprolide acetate
|
Drug: leuprolide acetate
leuprolide acetate (22.5 mg every 12 weeks)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least one of the following features:
Exclusion Criteria:
Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: David Flanagan 617-632-3237 | |
| Contact: Judith Prisby, RN 617-582-8313 | |
| Principal Investigator: Mary-Ellen Taplin, MD | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Mary Ellen Morrissey, RN 617-667-9187 mmorris1@bidmc.harvard.edu | |
| Contact: Stephen Duggan 617-632-9281 | |
| Principal Investigator: Glenn Bubley, MD | |
| United States, New York | |
| Roswell Park Cancer Institute | Not yet recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: James Mohler, MD 716-845-8433 james.mohler@roswellpark.org | |
| Principal Investigator: James Mohler, MD | |
| United States, Texas | |
| The University of Texas MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Christopher Logothetis, MD 713-792-2830 | |
| Principal Investigator: Christopher Logothetis, MD | |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Christine Wallace 206-288-7023 wallacec@seattlecca.org | |
| Contact: Tove Thompson 206-288-12323 tovethom@seattlecca.org | |
| Principal Investigator: Bruce Montgomery, MD | |
| Study Director: | Chris Haqq, MD, PhD | Cougar Biotechnology, Inc. |
More Information
| Responsible Party: | Cougar Biotechnology, Inc. ( Christopher M. Haqq MD PhD / Vice President, Clinical Research and Development ) |
| Study ID Numbers: | COU-AA-201 |
| Study First Received: | June 17, 2009 |
| Last Updated: | January 26, 2010 |
| ClinicalTrials.gov Identifier: | NCT00924469 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Prostate cancer Abiraterone acetate Leuprolide acetate Prednisone |
CB7630 Testosterone Localized high risk prostate cancer |
|
Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Reproductive Control Agents Genital Diseases, Male |
Glucocorticoids Hormones Pharmacologic Actions Neoplasms Neoplasms by Site Leuprolide Fertility Agents, Female Therapeutic Uses Fertility Agents Prostatic Neoplasms |