The Plenaxis® Experience Study

PRAECIS Pharmaceuticals

Status and phase: Suspended; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: Plenaxis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00103623

149-IV-01

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)