Spots Global Cancer Trial Database for IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
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Trial Identification
Brief Title: IMAAGEN: Impact of Abiraterone Acetate in Prostate-Specific Antigen
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
Study ID: NCT01314118
Interventions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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
Contact Details
Name: Janssen Services, LLC. Clinical Trial
Affiliation: Janssen Biotech, Inc.
Role: STUDY_DIRECTOR
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