The Plenaxis® Experience Study
Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
1 other identifier
interventional
2,000
1 country
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 prostate-cancer
Started Jun 2004
Longer than P75 for phase_4 prostate-cancer
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 11, 2005
CompletedFirst Posted
Study publicly available on registry
February 14, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedSeptember 19, 2006
September 1, 2006
February 11, 2005
September 18, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Millenium Therapeutics & Research - Urology Practice
Birmingham, Alabama, 35205, United States
Valley Urologic Associates
Goodyear, Arizona, 85338, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013, United States
Arizona Urologic Specialists
Tucson, Arizona, 85712, United States
Alfred Sidhom, MD, FACS, PC
Anaheim, California, 92801, United States
Dr. Chris Threatt
Atherton, California, 94027, United States
Hematology-Oncology Group of Fresno
Fresno, California, 93720, United States
South Orange County Medical Research Center
Laguna Woods, California, 92653, United States
Atlantic Urological Medical Group
Long Beach, California, 90806, United States
Paul Neustein, MD. INC
Poway, California, 92064, United States
San Diego Urology
San Diego, California, 91942, United States
Sherman Oaks Urological Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Urology Associates PC
Denver, Colorado, 80210, United States
Urologic Associates
Fort Meyers, Florida, 33919, United States
Southwest Florida Urologic Associates
Fort Myers, Florida, 33907, United States
University of Florida Shands Jacksonville
Jacksonville, Florida, 32209, United States
UroSearch
Ocala, Florida, 34470, United States
Urology Associates of Ocala, P.A.
Ocala, Florida, 34474, United States
South Florida Urology Center Inc
Pembroke Pines, Florida, 33028, United States
South Florida Urology Center, Inc.
Pembroke Pines, Florida, 33028, United States
Uro-Medix, Inc
Sunrise, Florida, 33351, United States
Osvaldo F. Padron MD, FACS
Tampa, Florida, 33614, United States
Urological Surgical Services
Tavares, Florida, 32778, United States
Osler Medical
West Melbourne, Florida, 32901, United States
Urology Associates, P.C.
Marietta, Georgia, 30060, United States
Praire Medical Associates, LTD
Chicago, Illinois, 60616, United States
Midwest Prostate Urology Health Center
Chicago, Illinois, 60640, United States
Urology of Indiana
Indianapolis, Indiana, 46254, United States
Unity HealthCare DBA Lafayette Clinic of Urology
Lafayette, Indiana, 47905, United States
Heartland Oncology and Hematology
Council Bluffs, Iowa, 51503, United States
Private Practice
Emporia, Kansas, 66801, United States
KUMC Department of Urology
Kansas City, Kansas, 66160, United States
Tri-County Urology
Milford, Massachusetts, 01757, United States
Bay State Clinical Trials Inc
Watertown, Massachusetts, 02472, United States
Lakeside Urology
Saint Joseph, Michigan, 49085, United States
Tewodros Fresseha MD PC
Southfield, Michigan, 48075, United States
Midwest Urology
Independence, Missouri, 64055, United States
Kansas City Urology Care
Kansas City, Missouri, 64131, United States
Quality Clinical Research, LLC
Omaha, Nebraska, 68114, United States
Sheldon j. Freedman, MD Ltd
Las Vegas, Nevada, 89109, United States
Essex-Hudson Urology
Bloomfield, New Jersey, 07003, United States
Hunterdon Urological Associates, PA
Flemington, New Jersey, 08822, United States
Northwest Urology Associates
Morristown, New Jersey, 07960, United States
Roseland Surgical Suite
Roseland, New Jersey, 07068, United States
Urology Healthcare Associates/Rancocas Medical Center
Willingboro, New Jersey, 08046, United States
Staten Island Urological Research, PC
Staten Island, New York, 10304, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599, United States
American Health Research
Charlotte, North Carolina, 28207, United States
Northeast Urology Research
Concord, North Carolina, 28025, United States
Washington Urological Associates
Washington, North Carolina, 27889, United States
Columbus Urology Research
Columbus, Ohio, 43214, United States
Parkhurst Research Organization
Bethany, Oklahoma, 73008, United States
Bryn Mawr Urology
Devon, Pennsylvania, 19333, United States
Dr. Peter Sinaiko
Langhorne, Pennsylvania, 19047, United States
Urology and Urological Oncology
Philadelphia, Pennsylvania, 19141, United States
Triangle Urological Group
Pittsburgh, Pennsylvania, 15212, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Dr. Greg Echt
Irving, Texas, 75062, United States
North West Prostate Institute
Seattle, Washington, 98133, United States
Roger D. Fincher, MD
Spokane, Washington, 99202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gerald Riedel, PhD
PRAECIS Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 11, 2005
First Posted
February 14, 2005
Study Start
June 1, 2004
Study Completion
December 1, 2008
Last Updated
September 19, 2006
Record last verified: 2006-09