The Plenaxis® Experience Study

• Status: Suspended
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Male

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 receiving Plenaxis®. The purpose of the study is to estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis® and to determine whether the hazard rate changes over time.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PRAECIS Pharmaceuticals Inc.
• Treatments: Abarelix

Criteria

Inclusion Criteria:

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:

1. Risk of neurological compromise due to metastases,

2. Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or

3. 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 Criteria:

• Female Patients,

• Pediatric patients,

• Patients with known hypersensitivity to any of the components in the abarelix injectable suspension