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Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®


Phase 4
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®


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.


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:

1. Risk of neurological compromise due to metastases,

2. Ureteral or bladder outlet obstruction due to local encroachment or metastatic
disease or

3. 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis

Principal Investigator

Gerald Riedel, PhD

Investigator Role:

Study Director

Investigator Affiliation:

PRAECIS Pharmaceuticals Inc.

Authority:

United States: Food and Drug Administration

Study ID:

149-IV-01

NCT ID:

NCT00103623

Start Date:

June 2004

Completion Date:

December 2008

Related Keywords:

  • Prostate Cancer
  • Advanced
  • Symptomatic
  • Prostate
  • Cancer
  • Advanced Symptomatic Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Foundation for Cancer Research and Education Phoenix, Arizona  85013
Bryn Mawr Urology Bryn Mawr, Pennsylvania  19010
UroSearch Leesburg, Florida  34748
Atlantic Urological Medical Group Long Beach, California  90806
Kansas City Urology Care Kansas City, Missouri  64131
South Orange County Medical Research Center Laguna Hills, California  92653
Heartland Oncology and Hematology Council Bluffs, Iowa  51503
Northeast Urology Research Concord, North Carolina  28025
Staten Island Urological Research, PC Staten Island, New York  10304
Triangle Urological Group Pittsburgh, Pennsylvania  15212
Carolina Urologic Research Center Myrtle Beach, South Carolina  29572
Millenium Therapeutics & Research - Urology Practice Birmingham, Alabama  35205
Valley Urologic Associates Goodyear, Arizona  85338
Arizona Urologic Specialists Tucson, Arizona  85712
Alfred Sidhom, MD, FACS, PC Anaheim, California  92801
Dr. Chris Threatt Atherton, California  94027
Hematology-Oncology Group of Fresno Fresno, California  93720
Paul Neustein, MD. INC Poway, California  92064
San Diego Urology San Diego, California  91942
Sherman Oaks Urological Medical Group, Inc. Sherman Oaks, California  91403
Urology Associates PC Denver, Colorado  80210
Urologic Associates Fort Meyers, Florida  33919
Southwest Florida Urologic Associates Fort Myers, Florida  33907
University of Florida Shands Jacksonville Jacksonville, Florida  32209
Urology Associates of Ocala, P.A. Ocala, Florida  34474
South Florida Urology Center, Inc. Pembroke Pines, Florida  33028
South Florida Urology Center Inc Pembroke Pines, Florida  33028
Uro-Medix, Inc Sunrise, Florida  33351
Osvaldo F. Padron MD, FACS Tampa, Florida  33614
Urological Surgical Services Tavares, Florida  32778
Osler Medical West Melbourne, Florida  32901
Urology Associates, P.C. Marietta, Georgia  30060
Midwest Prostate Urology Health Center Chicago, Illinois  60640
Praire Medical Associates, LTD Chicago, Illinois  60616
Urology of Indiana Indianapolis, Indiana  46254
Unity HealthCare DBA Lafayette Clinic of Urology Lafayette, Indiana  47905
Private Practice Emporia, Kansas  66801
KUMC Department of Urology Kansas City, Kansas  66160
Tri-County Urology Milford, Massachusetts  01757
Bay State Clinical Trials Inc Watertown, Massachusetts  02472
Tewodros Fresseha MD PC Southfield, Michigan  48075
Lakeside Urology St. Joseph, Michigan  49085
Midwest Urology Independence, Missouri  64055
Quality Clinical Research, LLC Omaha, Nebraska  68114
Sheldon j. Freedman, MD Ltd Las Vegas, Nevada  89109
Essex-Hudson Urology Bloomfield, New Jersey  07003
Hunterdon Urological Associates, PA Flemington, New Jersey  08822
Northwest Urology Associates Morristown, New Jersey  07960
Roseland Surgical Suite Roseland, New Jersey  07068
Urology Healthcare Associates/Rancocas Medical Center Willingboro, New Jersey  08046
University of North Carolina, Chapel Hill Chapel Hill, North Carolina  27599
American Health Research Charlotte, North Carolina  28207
Washington Urological Associates Washington, North Carolina  27889
Columbus Urology Research Columbus, Ohio  43214
Parkhurst Research Organization Bethany, Oklahoma  73008
Dr. Peter Sinaiko Langhorne, Pennsylvania  19047
Urology and Urological Oncology Philadelphia, Pennsylvania  19141
Dr. Greg Echt Irving, Texas  75062
North West Prostate Institute Seattle, Washington  98133
Roger D. Fincher, MD Spokane, Washington  99202