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Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®

Phase 4
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Gerald Riedel, PhD

Investigator Role:

Study Director

Investigator Affiliation:

PRAECIS Pharmaceuticals Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

December 2008

Related Keywords:

  • Prostate Cancer
  • Advanced
  • Symptomatic
  • Prostate
  • Cancer
  • Advanced Symptomatic Prostate Cancer
  • Prostatic Neoplasms



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