IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

NCT01314118 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CR017932212082PCR2005
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 45

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.

Conditions

Prostate Cancer; Prostatic Neoplasm

Keywords

abiraterone acetate; prednisone; zytiga

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study

  Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.

  End of core study visit (Approximately at Month 6)

Secondary Outcomes (3)

• Time to Radiographic Evidence of Disease Progression (TTRP)

  Maximum up to Month 30.5

• Time to Prostate-Specific Antigen (PSA) Progression

  Maximum up to Month 30.5

• Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment

  End of Cycle 3 (Approximately Month 3)

Study Arms (1)

001

EXPERIMENTAL

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.

Drug: abiraterone acetate in combination with prednisone

Interventions

abiraterone acetate in combination with prednisone 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.

001

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Janssen Biotech, Inc.: lead

Study Sites (45)

Unknown Facility

Homewood, Alabama, United States

Location

Unknown Facility

Huntsville, Alabama, United States

Location

Unknown Facility

Tucson, Arizona, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Aventura, Florida, United States

Location

Unknown Facility

Orange City, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Evanston, Illinois, United States

Location

Unknown Facility

Galesburg, Illinois, United States

Location

Unknown Facility

Glenview, Illinois, United States

Location

Unknown Facility

Melrose Park, Illinois, United States

Location

Unknown Facility

Fort Wayne, Indiana, United States

Location

Unknown Facility

Jeffersonville, Indiana, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Rockville, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Lansing, Michigan, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Lawrenceville, New Jersey, United States

Location

Unknown Facility

Albany, New York, United States

Location

Unknown Facility

Brooklyn, New York, United States

Location

Unknown Facility

Buffalo, New York, United States

Location

Unknown Facility

Garden City, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Poughkeepsie, New York, United States

Location

Unknown Facility

Staten Island, New York, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Raleigh, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

Unknown Facility

Lancaster, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Greenville, South Carolina, United States

Location

Unknown Facility

Myrtle Beach, South Carolina, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Arlington, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Abiraterone Acetate; 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; Pregnadienediols; Pregnadienes; Pregnanes

Results Point of Contact

• Title: Medical Director
• Organization: Janssen Services, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Services, LLC. Clinical Trial

  Janssen Biotech, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 14, 2011
• Study Start: May 4, 2011
• Primary Completion: December 24, 2013
• Study Completion: December 2, 2024
• Last Updated: February 24, 2026
• Results First Posted: January 7, 2015

Record last verified: 2026-02

Locations

US (45)