The Plenaxis® Experience Study

Phase 4

Suspended

• Conditions: Prostate Cancer

• Registration Number: NCT00103623
• Lead Sponsor: PRAECIS Pharmaceuticals Inc.

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 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.

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 charts audited to record the number of immediate-onset systemic allergic reactions that may occur while receiving Plenaxis®. The study will close when 2,000 patients have been enrolled. If immediate onset allergic reactions occur, patients may be eligible to enroll in a second protocol (skin testing in patients who experience an immediate onset allergic reaction). Collection of all immediate-onset systemic allergic reactions will continue for each patient enrolled in the study until the patient discontinues Plenaxis® for any reason, the patient withdraws consent to continue in the study or the patient is lost to follow-up.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2005-02-11
• Study First Submitted QC: 2005-02-11
• Study First Posted: 2005-02-14
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-18
• Last Update Posted: 2006-09-19
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis

Trial Locations

Locations (60)

Millenium Therapeutics & Research - Urology Practice; 🇺🇸 Birmingham, Alabama, United States

Valley Urologic Associates; 🇺🇸 Goodyear, Arizona, United States

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Arizona Urologic Specialists; 🇺🇸 Tucson, Arizona, United States

Alfred Sidhom, MD, FACS, PC; 🇺🇸 Anaheim, California, United States

Dr. Chris Threatt; 🇺🇸 Atherton, California, United States

Hematology-Oncology Group of Fresno; 🇺🇸 Fresno, California, United States

South Orange County Medical Research Center; 🇺🇸 Laguna Woods, California, United States

Atlantic Urological Medical Group; 🇺🇸 Long Beach, California, United States

Paul Neustein, MD. INC; 🇺🇸 Poway, California, United States

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