Prostate Cancer Clinical Trial

The Plenaxis® Experience Study

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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:

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.

Exclusion Criteria:

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

Study is for people with:

Prostate Cancer

Phase:

Phase 4

Estimated Enrollment:

2000

Study ID:

NCT00103623

Recruitment Status:

Suspended

Sponsor:

PRAECIS Pharmaceuticals Inc.

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There are 59 Locations for this study

See Locations Near You

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
Tewodros Fresseha MD PC
Southfield Michigan, 48075, United States
Lakeside Urology
St. Joseph Michigan, 49085, 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

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 4

Estimated Enrollment:

2000

Study ID:

NCT00103623

Recruitment Status:

Suspended

Sponsor:


PRAECIS Pharmaceuticals Inc.

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