The Plenaxis® Experience Study
- Conditions
- Prostate Cancer
- Registration Number
- NCT00103623
- Lead Sponsor
- PRAECIS Pharmaceuticals Inc.
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Male
- Target Recruitment
- 2000
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.
- Female Patients,
- Pediatric patients,
- Patients with known hypersensitivity to any of the components in the abarelix injectable suspension
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
Alfred Sidhom, MD, FACS, PC
🇺🇸Anaheim, California, United States
Hematology-Oncology Group of Fresno
🇺🇸Fresno, California, United States
Urology Associates, P.C.
🇺🇸Marietta, Georgia, United States
Praire Medical Associates, LTD
🇺🇸Chicago, Illinois, United States
Tewodros Fresseha MD PC
🇺🇸Southfield, Michigan, United States
North West Prostate Institute
🇺🇸Seattle, Washington, United States
Triangle Urological Group
🇺🇸Pittsburgh, Pennsylvania, United States
Urology of Indiana
🇺🇸Indianapolis, Indiana, United States
San Diego Urology
🇺🇸San Diego, California, United States
KUMC Department of Urology
🇺🇸Kansas City, Kansas, United States
Private Practice
🇺🇸Emporia, Kansas, United States
Urology Associates PC
🇺🇸Denver, Colorado, United States
Millenium Therapeutics & Research - Urology Practice
🇺🇸Birmingham, Alabama, United States
Uro-Medix, Inc
🇺🇸Sunrise, Florida, United States
Valley Urologic Associates
🇺🇸Goodyear, Arizona, United States
Urologic Associates
🇺🇸Fort Meyers, Florida, United States
South Florida Urology Center, Inc.
🇺🇸Pembroke Pines, Florida, United States
Foundation for Cancer Research and Education
🇺🇸Phoenix, Arizona, United States
Osvaldo F. Padron MD, FACS
🇺🇸Tampa, Florida, United States
Southwest Florida Urologic Associates
🇺🇸Fort Myers, Florida, United States
Arizona Urologic Specialists
🇺🇸Tucson, Arizona, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Tri-County Urology
🇺🇸Milford, Massachusetts, United States
Urology Associates of Ocala, P.A.
🇺🇸Ocala, Florida, United States
South Florida Urology Center Inc
🇺🇸Pembroke Pines, Florida, United States
Hunterdon Urological Associates, PA
🇺🇸Flemington, New Jersey, United States
Osler Medical
🇺🇸West Melbourne, Florida, United States
Roseland Surgical Suite
🇺🇸Roseland, New Jersey, United States
University of Florida Shands Jacksonville
🇺🇸Jacksonville, Florida, United States
Urology Healthcare Associates/Rancocas Medical Center
🇺🇸Willingboro, New Jersey, United States
Bay State Clinical Trials Inc
🇺🇸Watertown, Massachusetts, United States
Dr. Chris Threatt
🇺🇸Atherton, California, United States
South Orange County Medical Research Center
🇺🇸Laguna Woods, California, United States
Paul Neustein, MD. INC
🇺🇸Poway, California, United States
Sherman Oaks Urological Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
UroSearch
🇺🇸Ocala, Florida, United States
Unity HealthCare DBA Lafayette Clinic of Urology
🇺🇸Lafayette, Indiana, United States
Midwest Prostate Urology Health Center
🇺🇸Chicago, Illinois, United States
Heartland Oncology and Hematology
🇺🇸Council Bluffs, Iowa, United States
Midwest Urology
🇺🇸Independence, Missouri, United States
Lakeside Urology
🇺🇸St. Joseph, Michigan, United States
Quality Clinical Research, LLC
🇺🇸Omaha, Nebraska, United States
Sheldon j. Freedman, MD Ltd
🇺🇸Las Vegas, Nevada, United States
Kansas City Urology Care
🇺🇸Kansas City, Missouri, United States
Staten Island Urological Research, PC
🇺🇸Staten Island, New York, United States
Northwest Urology Associates
🇺🇸Morristown, New Jersey, United States
University of North Carolina, Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
American Health Research
🇺🇸Charlotte, North Carolina, United States
Washington Urological Associates
🇺🇸Washington, North Carolina, United States
Columbus Urology Research
🇺🇸Columbus, Ohio, United States
Parkhurst Research Organization
🇺🇸Bethany, Oklahoma, United States
Northeast Urology Research
🇺🇸Concord, North Carolina, United States
Bryn Mawr Urology
🇺🇸Devon, Pennsylvania, United States
Urology and Urological Oncology
🇺🇸Philadelphia, Pennsylvania, United States
Dr. Peter Sinaiko
🇺🇸Langhorne, Pennsylvania, United States
Dr. Greg Echt
🇺🇸Irving, Texas, United States
Roger D. Fincher, MD
🇺🇸Spokane, Washington, United States
Atlantic Urological Medical Group
🇺🇸Long Beach, California, United States
Urological Surgical Services
🇺🇸Tavares, Florida, United States
Essex-Hudson Urology
🇺🇸Bloomfield, New Jersey, United States