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Neoadjuvant Abiraterone Acetate Plus Leuprolide Acetate in Men With Localized High Risk Prostate Cancer
This study is currently recruiting participants.
Verified by Cougar Biotechnology, Inc., January 2010
First Received: June 17, 2009   Last Updated: January 26, 2010   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Cougar Biotechnology, Inc.:

Primary Outcome Measures:
  • To compare serum and prostate tissue androgen levels [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathologic complete response rate at prostatectomy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Prostate specific antigen response rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Tumor expression of AR regulated genes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Molecular correlates [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

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
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924469

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            
Sponsors and Collaborators
Cougar Biotechnology, Inc.
Investigators
Study Director: Chris Haqq, MD, PhD Cougar Biotechnology, Inc.
  More Information

Additional Information:
No publications provided

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

Keywords provided by Cougar Biotechnology, Inc.:
Prostate cancer
Abiraterone acetate
Leuprolide acetate
Prednisone
CB7630
Testosterone
Localized high risk prostate cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010