The Plenaxis® Experience Study

Paused · Phase 4

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00103623

Run by

PRAECIS Pharmaceuticals Inc.

People needed

2000

Starts

2004-06-01

Expected to finish

2008-12-01

Last updated by the study team

2006-09-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Risk of neurological compromise due to metastases,
• Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or
• 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.

You may not qualify if…

• Female Patients,
• Pediatric patients,
• Patients with known hypersensitivity to any of the components in the abarelix injectable suspension

Where it is running

• 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
• San Diego Urology — San Diego, California, United States
• Sherman Oaks Urological Medical Group, Inc. — Sherman Oaks, California, United States
• Urology Associates PC — Denver, Colorado, United States
• Urologic Associates — Fort Meyers, Florida, United States
• Southwest Florida Urologic Associates — Fort Myers, Florida, United States
• University of Florida Shands Jacksonville — Jacksonville, Florida, United States
• UroSearch — Ocala, Florida, United States
• Urology Associates of Ocala, P.A. — Ocala, Florida, United States
• South Florida Urology Center Inc — Pembroke Pines, Florida, United States
• South Florida Urology Center, Inc. — Pembroke Pines, Florida, United States
• Uro-Medix, Inc — Sunrise, Florida, United States
• Osvaldo F. Padron MD, FACS — Tampa, Florida, United States
• Urological Surgical Services — Tavares, Florida, United States
• Osler Medical — West Melbourne, Florida, United States
• Urology Associates, P.C. — Marietta, Georgia, United States
• Millenium Therapeutics & Research - Urology Practice — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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