Prostate Cancer
Conditions
Keywords
Advanced, Symptomatic, Prostate, Cancer, Advanced Symptomatic Prostate Cancer
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.
Interventions
DRUGPlenaxis
Sponsors
PRAECIS Pharmaceuticals Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis | — |
Countries
United States
Outcome results
None listed