Status:
SUSPENDED
The Plenaxis® Experience Study
Lead Sponsor:
PRAECIS Pharmaceuticals Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated population of patients rec...
Detailed Description
This is a postmarketing patient safety study in the FDA indicated population of patients receiving Plenaxis®. On a quarterly basis, patients enrolled in the Plenaxis® Experience Study will have their ...
Eligibility Criteria
Inclusion
- A subject is eligible to participate in the study if he meets the following criteria:
- Male ≥ 18 years old with advanced symptomatic prostate cancer for whom LHRH agonist therapy is not appropriate and who refuses surgical castration
- Has at least one of the following:
- Risk of neurological compromise due to metastases,
- Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or
- Severe bone pain from skeletal metastases persisting on narcotic analgesia
- Patients or their legal representatives must be able to read, understand and sign an informed consent form to participate in the trial.
Exclusion
- Female Patients,
- Pediatric patients,
- Patients with known hypersensitivity to any of the components in the abarelix injectable suspension
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2008
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00103623
Start Date
June 1 2004
End Date
December 1 2008
Last Update
September 19 2006
Active Locations (60)
Enter a location and click search to find clinical trials sorted by distance.
1
Millenium Therapeutics & Research - Urology Practice
Birmingham, Alabama, United States, 35205
2
Valley Urologic Associates
Goodyear, Arizona, United States, 85338
3
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
4
Arizona Urologic Specialists
Tucson, Arizona, United States, 85712