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
This is a Phase 2, prospective, multicenter, open-label (both the patient and investigator
will know what treatment is taken), single-arm study of abiraterone acetate plus prednisone
in patients with non-metastatic (has not spread in the body), castration-resistant prostate
cancer (CRPC) who have a rising PSA despite castrate levels of testosterone. This study has
4 phases: Screening Phase (up to 28 Days); Core Study Treatment Phase (Treatment-Cycle 1-6);
Follow-up Phase (Treatment-Cycle 7- until disease progression); and an Extension Phase
(after the end of the official study). Each treatment cycle will last 28 days (about a
month). Your participation in the study will include a screening period of up to 28 days,
which allows the doctor to assess whether or not you qualify for the study. There is a Core
Treatment Phase where study medication is taken for six treatment cycles (about 6 months).
There is a Follow-up Phase where study medication will continue to be taken until your
prostate cancer progresses, or you have unacceptable toxicities or this phase of the study
ends (approximately 18 months). If your prostate cancer progresses before the end of the
follow-up phase, you will not be given further study medication. However, the study doctor
will contact you about every 2 months to record any new therapy for prostate cancer you are
taking until the end of the follow-up phase. If for some reason you stop study medication
before the end of the follow-up phase, the study doctor will contact you about every 2
months to record any new therapy for prostate cancer you are taking until the end of the
follow-up phase or until your prostate cancer progresses, whichever happens first. You will
be required to return to the study site 30 days after receiving your last dose of
abiraterone acetate for safety follow-up. You may be in the study for about 24 months. Four
abiraterone acetate tablets should be taken by mouth [PO] at least 2 hours after eating & no
food should be eaten for at least 1 hour afterward. Two (2.5 mg) prednisone tablets will be
taken PO once daily, preferably with food. Patients may continue abiraterone acetate until
disease progression, until unacceptable toxicities develop, until abiraterone acetate
becomes commercially available for the indication being studied, or until the sponsor
determines it is necessary to stop the study.
Major
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of patients with >= 50% reduction in PSA after 6 cycles of treatment or by the End of Core Study Visit
Approximately 6 months
No
Janssen Services, LLC. Clinical Trial
Study Director
Janssen Biotech, Inc.
United States: Food and Drug Administration
CR017932
NCT01314118
May 2011
July 2015
Name | Location |
---|---|
Hinsdale, Illinois 60521 | |
Albany, Georgia 31701 | |
Birmingham, Alabama 35294 | |
Phoenix, Arizona 85012 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Albany, New York 12208 | |
Cleveland, Ohio 44195 | |
Philadelphia, Pennsylvania 19104 | |
Nashville, Tennessee 37203-1632 | |
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Flint, Michigan 48532 | |
Omaha, Nebraska 68114 | |
Hackensack, New Jersey 07601 | |
Metairie, Louisiana 70006 | |
Denver, Colorado | |
Baltimore, Maryland 21287 | |
Boston, Massachusetts | |
Charlotte, North Carolina | |
Milwaukee, Wisconsin | |
Indianapolis, Indiana | |
Charleston, South Carolina |