IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

NCT ID: NCT01314118

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-04
• Study Completion Date: 2024-12-02

Brief Summary

The purpose of this study is to show that abiraterone acetate plus prednisone added to the current standard of care, gonadotropin-releasing hormone (GnRH) decreases prostate specific antigen (PSA) and prolongs the time until it is evident that the cancer has grown. Additionally, safety information about abiraterone acetate in combination with prednisone will be collected. This will include looking at what side effects occur, how often they occur, and for how long they last.

Detailed Description

This is a Phase 2, prospective, multicenter, open-label, single-arm study of abiraterone acetate plus prednisone in men with non-metastatic, castration-resistant prostate cancer (CRPC) who have a rising PSA despite castrate levels of testosterone. The study consists of Screening Phase (up to 4 weeks), Core Study Treatment Phase (comprised of six 28-day cycles), a Pre-metastatic Disease Follow-up Phase, an Optional Drug Holiday Phase; and a 30-day Safety Follow-up Visit. Each treatment cycle will last 28 days. Participating participants will receive study agents (Abiraterone acetate 1000 mg/day plus prednisone 5 mg/day, orally) continually during the study. If the partcipants elects to participate in the Optional Drug Holiday Phase, participants will discontinue abiraterone acetate plus prednisone and ADT. Participants will have the option to return to study medication during the first year of the Optional Drug Holiday Phase if there is evidence of rising PSA but no metastasis based on study imaging. If participants do no elect to participate, they will continue with the core study treatment as per protocol. The study will end when all participated participants have disease progression or end of the 2-year period (if participants participated in the Optional Drug Holiday Phase). Participants will be required to return to the study site 30 days after receiving the last dose of abiraterone acetate for safety follow-up.

Conditions

Prostate Cancer; Prostatic Neoplasm

Keywords

abiraterone acetate; prednisone; zytiga

Study Design

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

Study Groups

001

abiraterone acetate in combination with prednisone Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.

Group Type: EXPERIMENTAL

abiraterone acetate in combination with prednisone

Intervention Type: DRUG

Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.

Interventions

abiraterone acetate in combination with prednisone

Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Be a male >= 18 years of age
• Have adenocarcinoma of the prostate
• Currently receiving continuous treatment with Gonadotropin-releasing hormone (GnRH) monotherapy for at least 6 months before or have undergone surgical removal of the testicles
• Serum testosterone of < 50 ng/dL(< 2.0 nM)
• Have rising PSA defined as a PSA of >= 10 ng/mL obtained at screening or PSADT of ≤ 10 months with the first of the 3 consecutive PSA values used to calculate PSADT ≥ 2.0 ng/mL
• Have an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
• Be capable of swallowing study agents whole as a tablet
• Be willing/able to adhere to the prohibitions and restrictions specified in this protocol

Exclusion Criteria

• Have prior or current evidence of local disease progression or metastatic disease as defined by modified response evaluation criteria in solid tumors (RECIST) criteria
• Have received chemotherapy for treatment of castrate-resistant prostate cancer; however, if a patient received chemotherapy in an adjuvant setting, prior to having CRPC, for castrate-sensitive prostate cancer, the patient is still eligible
• Are currently receiving any antiandrogen therapy (eg, bicalutamide, flutamide, or nilutamide).
• If previously treated with antiandrogen therapy, there must be documentation of at least 2 consecutive rising PSA values at least 2 weeks apart obtained prior to screening
• If previously treated with flutamide, at least 1 of the PSA values must be obtained 4 weeks or more after flutamide discontinuation.
• If previously treated with bicalutamide or nilutamide, at least 1 of the PSA values must be obtained 6 weeks or more after antiandrogen discontinuation
• Have previously received agents having any CYP17 inhibitory activity for the treatment of prostate cancer, such as ketoconazole
• Have previously received aminoglutethimide
• Have an active infection or other medical condition that would contraindicate prednisone use
• Have uncontrolled hypertension
• Have active hepatitis or chronic liver disease
• Have clinically significant heart disease
• Have poorly controlled diabetes
• Have received an investigational therapeutic within 30 days of screening
• Have partners of childbearing potential and are not willing to use a method of birth control with adequate barrier protection as determined to be acceptable by the principal investigator and sponsor during the study and for 1 week after last dose of abiraterone acetate.
• Individuals with a history of a non-prostate malignancy are ineligible for this study with the following exceptions. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: basal cell or squamous cell carcinoma of the skin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Janssen Biotech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Services, LLC. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Biotech, Inc.

Locations

Homewood, Alabama, United States

Huntsville, Alabama, United States

Tucson, Arizona, United States

Los Angeles, California, United States

San Diego, California, United States

San Francisco, California, United States

Aurora, Colorado, United States

Denver, Colorado, United States

Aventura, Florida, United States

Orange City, Florida, United States

Atlanta, Georgia, United States

Evanston, Illinois, United States

Galesburg, Illinois, United States

Glenview, Illinois, United States

Melrose Park, Illinois, United States

Fort Wayne, Indiana, United States

Jeffersonville, Indiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Rockville, Maryland, United States

Boston, Massachusetts, United States

Lansing, Michigan, United States

Omaha, Nebraska, United States

Lawrenceville, New Jersey, United States

Albany, New York, United States

Brooklyn, New York, United States

Buffalo, New York, United States

Garden City, New York, United States

New York, New York, United States

Poughkeepsie, New York, United States

Staten Island, New York, United States

Chapel Hill, North Carolina, United States

Raleigh, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Lancaster, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Greenville, South Carolina, United States

Myrtle Beach, South Carolina, United States

Nashville, Tennessee, United States

Arlington, Texas, United States

Houston, Texas, United States

Seattle, Washington, United States

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

212082PCR2005

Identifier Type: OTHER

Identifier Source: secondary_id

CR017932

Identifier Type: -

Identifier Source: org_study_id