A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer

NCT00924469 | Completed Phase 2 Results

• 2 other identifiers: CR016936COU-AA-201
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery to remove all or part of the prostate gland).

Conditions

Prostate Cancer

Keywords

Prostate cancer; Abiraterone acetate; Leuprolide acetate; Prednisone; CB7630; Testosterone

Outcome Measures

Primary Outcomes (2)

• Testosterone Concentration in Prostate Tissue

  Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.

  Week 12

• Dihydrotestosterone (DHT) Concentration in Prostate Tissue

  The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.

  Week 12

Secondary Outcomes (7)

• Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue

  Week 24

• Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue

  Week 12 and 24

• Serum Levels of Androgens

  Week 12 and 24

• Percentage of Participants With Prostate-specific Antigen (PSA) Response

  Weeks 12 and 24

• Percentage of Participants With Pathologic Complete Response (CR)

  Week 24

Study Arms (2)

Abiraterone plus leuprolide plus prednisone

EXPERIMENTAL

Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks.

Drug: Abiraterone; Drug: Leuprolide; Drug: Prednisone

Leuprolide then abiraterone plus leuprolide plus prednisone

ACTIVE COMPARATOR

Leuprolide acetate will be administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day with prednisone tablets administered orally as 5 mg once daily.

Drug: Abiraterone; Drug: Leuprolide; Drug: Prednisone

Interventions

Abiraterone DRUG

Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day at least 1 hour before a meal or 2 hours after a meal for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2.

Also known as: CB7630

Abiraterone plus leuprolide plus prednisone; Leuprolide then abiraterone plus leuprolide plus prednisone

Leuprolide DRUG

Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks in Group 1 and Group 2.

Abiraterone plus leuprolide plus prednisone; Leuprolide then abiraterone plus leuprolide plus prednisone

Prednisone DRUG

Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks in Group 1 and from Week 13 to Week 24 for Group 2.

Abiraterone plus leuprolide plus prednisone; Leuprolide then abiraterone plus leuprolide plus prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• At least three core biopsies positive for prostate cancer (a minimum of 6 core biopsies must be obtained at baseline). A prostate biopsy within 6 months from Screening is allowed for entry requirements
• At least one of the following features: prostate specific antigen (PSA) greater than (\>) 10 nanogram per milliliter (ng/ml); PSA velocity \>2 ng/ml per /year (defined as a rise in PSA of \>2 ng/ml in the preceding 12 month period); Gleason score greater than or equal to (\>=) 7 (4+3); Gleason score 6 if either PSA \>=10 ng/ml or PSA velocity \>=2 ng/ml/year
• Serum testosterone \>200 nanogram/deciliter
• Participant and urologist must agree that participant is suitable for prostatectomy

You may not qualify if:

• Serious or uncontrolled co-existent, non-malignant disease, including active and uncontrolled infection
• Abnormal liver function consisting of any of the following: serum bilirubin \>= 1.5 \* upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase \>=2.5 \* ULN
• Uncontrolled hypertension within the Screening period (systolic blood pressure \>= 160 millimeter of mercury \[mmHg\] or diastolic BP \>= 95 mmHg)
• Requirement for corticosteroids greater than the equivalent of 5 milligram of prednisone daily
• Participants with active or symptomatic viral hepatitis or chronic liver disease or clinically significant heart disease or as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of \< 50 percent at Baseline or history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Wenatchee, Washington, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

abiraterone; Abiraterone Acetate; Leuprolide; Prednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Senior Director, Clinical Research
• Organization: Janssen Research & Development, LLC 10990 Wilshire Blvd, Suite 1200 Los Angeles, CA 90024

(310) 914-2917

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: November 1, 2009
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 17, 2013
• Results First Posted: April 17, 2013

Record last verified: 2013-03

Locations

US (4)