Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Janssen Biotech, Inc. Identifier:
First received: March 4, 2011
Last updated: March 28, 2017
Last verified: March 2017
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.

Condition Intervention Phase
Prostate Cancer
Prostatic Neoplasm
Drug: abiraterone acetate in combination with prednisone
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Single-arm, Phase 2 Study of Abiraterone Acetate Plus Prednisone in Subjects With Advanced Prostate Cancer Without Radiographic Evidence of Metastatic Disease

Resource links provided by NLM:

Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) During the Core Study [ Time Frame: End of core study visit (Approximately at Month 6) ]
    Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed.

Secondary Outcome Measures:
  • Time to Radiographic Evidence of Disease Progression (TTRP) [ Time Frame: Maximum up to Month 30.5 ]
    Time to radiographic evidence of disease progression is defined as the time interval from the date of enrollment (Day 1) to the date of disease progression. A participant was considered as progressed by bone scan if: 1) The appearance of greater than or equal to (>=) 2 new lesions, and, following the first assessment, a confirmatory scan performed 6 or more weeks later that shows a minimum of 2 or more additional new lesions, 2) If >=2 new lesions are seen on scans following the first assessment, the confirmation is still required after 6 weeks; however, 2 addition lesions are not required to confirm progression, and 3) The date of progression is the date of the first scan that shows the changes.

  • Time to Prostate-Specific Antigen (PSA) Progression [ Time Frame: Maximum up to Month 30.5 ]
    Time to PSA progression is defined as the time interval from the date of enrollment (Day 1) to the date of first evidence of PSA progression. A participant was considered to have a PSA progression if the PSA level had a 25 percent (%) or greater increase and an absolute increase of 2 nanogram (ng)/milliliter (mL) or more, which is confirmed by a second value obtained in 3 or more weeks.

  • Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) Levels After 3 Cycles of Treatment [ Time Frame: End of Cycle 3 (Approximately Month 3) ]
    Percentage of participants with greater than or equal to 50 percent decrease in PSA levels was assessed. Decrease in PSA levels represented improvement.

Enrollment: 131
Actual Study Start Date: May 4, 2011
Estimated Study Completion Date: July 31, 2019
Primary Completion Date: December 24, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: 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.

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; and a 30-day Safety Follow-up Visit. Each treatment cycle will last 28 days. Participating subjects will receive study agents (Abiraterone acetate 1000 mg/day plus prednisone 5 mg/day, orally) continually during the study. Subjects who have not had radiographic confirmed disease progression after the Core Study Treatment Phase will continue the study treatment in the Pre-metastatic Disease Follow-up Phase. The study will end when all participated subjects have disease progression. Subjects will be required to return to the study site 30 days after receiving the last dose of abiraterone acetate for safety follow-up.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Major 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

Major 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01314118

  Hide Study Locations
United States, Alabama
Homewood, Alabama, United States
Huntsville, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
United States, Colorado
Aurora, Colorado, United States
Denver, Colorado, United States
United States, Florida
Aventura, Florida, United States
Orange City, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Evanston, Illinois, United States
Galesburg, Illinois, United States
Glenview, Illinois, United States
Melrose Park, Illinois, United States
United States, Indiana
Fort Wayne, Indiana, United States
Jeffersonville, Indiana, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Maryland
Rockville, Maryland, United States
Towson, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Lansing, Michigan, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, New Jersey
Lawrenceville, New Jersey, United States
United States, New York
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
United States, North Carolina
Chapel Hill, North Carolina, United States
Raleigh, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
United States, Pennsylvania
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Greenville, South Carolina, United States
Myrtle Beach, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Janssen Biotech, Inc.
Study Director: Janssen Services, LLC. Clinical Trial Janssen Biotech, Inc.
  More Information

Responsible Party: Janssen Biotech, Inc. Identifier: NCT01314118     History of Changes
Other Study ID Numbers: CR017932
Protocol 212082PCR2005 ( Other Identifier: Janssen Biotech Inc. )
Study First Received: March 4, 2011
Results First Received: December 24, 2014
Last Updated: March 28, 2017

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Janssen Biotech, Inc.:
abiraterone acetate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors processed this record on May 22, 2017