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.
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.
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
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There are 59 Locations for this study
Birmingham Alabama, 35205, United States
Goodyear Arizona, 85338, United States
Phoenix Arizona, 85013, United States
Tucson Arizona, 85712, United States
Anaheim California, 92801, United States
Atherton California, 94027, United States
Fresno California, 93720, United States
Laguna Woods California, 92653, United States
Long Beach California, 90806, United States
Poway California, 92064, United States
San Diego California, 91942, United States
Sherman Oaks California, 91403, United States
Denver Colorado, 80210, United States
Fort Meyers Florida, 33919, United States
Fort Myers Florida, 33907, United States
Jacksonville Florida, 32209, United States
Ocala Florida, 34470, United States
Ocala Florida, 34474, United States
Pembroke Pines Florida, 33028, United States
Pembroke Pines Florida, 33028, United States
Sunrise Florida, 33351, United States
Tampa Florida, 33614, United States
Tavares Florida, 32778, United States
West Melbourne Florida, 32901, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60616, United States
Chicago Illinois, 60640, United States
Indianapolis Indiana, 46254, United States
Lafayette Indiana, 47905, United States
Council Bluffs Iowa, 51503, United States
Emporia Kansas, 66801, United States
Kansas City Kansas, 66160, United States
Milford Massachusetts, 01757, United States
Watertown Massachusetts, 02472, United States
Southfield Michigan, 48075, United States
St. Joseph Michigan, 49085, United States
Independence Missouri, 64055, United States
Kansas City Missouri, 64131, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89109, United States
Bloomfield New Jersey, 07003, United States
Flemington New Jersey, 08822, United States
Morristown New Jersey, 07960, United States
Roseland New Jersey, 07068, United States
Willingboro New Jersey, 08046, United States
Staten Island New York, 10304, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28207, United States
Concord North Carolina, 28025, United States
Washington North Carolina, 27889, United States
Columbus Ohio, 43214, United States
Bethany Oklahoma, 73008, United States
Devon Pennsylvania, 19333, United States
Langhorne Pennsylvania, 19047, United States
Philadelphia Pennsylvania, 19141, United States
Pittsburgh Pennsylvania, 15212, United States
Myrtle Beach South Carolina, 29572, United States
Irving Texas, 75062, United States
Seattle Washington, 98133, United States
Spokane Washington, 99202, United States
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