Clinical trial · Interventional
The Plenaxis® Experience Study
Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plenaxis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available