The Plenaxis® Experience Study

Condition(s) targeted: Prostate Cancer

Intervention: Plenaxis (Drug)

Phase: Phase 4

Status: Suspended

Sponsored by: PRAECIS Pharmaceuticals Inc.

Official(s) and/or principal investigator(s):
Gerald Riedel, PhD, Study Director, Affiliation: PRAECIS PHARMACEUTICALS

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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:

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

Millenium Therapeutics & Research - Urology Practice, Birmingham, Alabama 35205, United States

Foundation for Cancer Research and Education, Phoenix, Arizona 85013, United States

Valley Urologic Associates, Goodyear, Arizona 85338, United States

Arizona Urologic Specialists, Tucson, Arizona 85712, United States

San Diego Urology, San Diego, California 91942, United States

Alfred Sidhom, MD, FACS, PC, Anaheim, California 92801, United States

South Orange County Medical Research Center, Laguna Woods, California 92653, United States

Sherman Oaks Urological Medical Group, Inc., Sherman Oaks, California 91403, United States

Hematology-Oncology Group of Fresno, Fresno, California 93720, United States

Dr. Chris Threatt, Atherton, California 94027, United States

Atlantic Urological Medical Group, Long Beach, California 90806, United States

Paul Neustein, MD. INC, Poway, California 92064, United States

Urology Associates PC, Denver, Colorado 80210, United States

South Florida Urology Center Inc, Pembroke Pines, Florida 33028, 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

Urological Surgical Services, Tavares, Florida 32778, United States

Uro-Medix, Inc, Sunrise, Florida 33351, United States

Southwest Florida Urologic Associates, Fort Myers, Florida 33907, United States

University of Florida Shands Jacksonville, Jacksonville, Florida 32209, United States

Osvaldo F. Padron MD, FACS, Tampa, Florida 33614, United States

Osler Medical, West Melbourne, Florida 32901, United States

Urologic Associates, Fort Meyers, Florida 33919, United States

Urology Associates, P.C., Marietta, Georgia 30060, United States

Midwest Prostate Urology Health Center, Chicago, Illinois 60640, United States

Praire Medical Associates, LTD, Chicago, Illinois 60616, 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

KUMC Department of Urology, Kansas City, Kansas 66160, United States

Private Practice, Emporia, Kansas 66801, United States

Bay State Clinical Trials Inc, Watertown, Massachusetts 02472, United States

Tri-County Urology, Milford, Massachusetts 01757, United States

Tewodros Fresseha MD PC, Southfield, Michigan 48075, United States

Lakeside Urology, St. Joseph, Michigan 49085, United States

Kansas City Urology Care, Kansas City, Missouri 64131, United States

Midwest Urology, Independence, Missouri 64055, United States

Quality Clinical Research, LLC, Omaha, Nebraska 68114, United States

Sheldon j. Freedman, MD Ltd, Las Vegas, Nevada 89109, United States

Urology Healthcare Associates/Rancocas Medical Center, Willingboro, New Jersey 08046, United States

Essex-Hudson Urology, Bloomfield, New Jersey 07003, United States

Roseland Surgical Suite, Roseland, New Jersey 07068, United States

Hunterdon Urological Associates, PA, Flemington, New Jersey 08822, United States

Northwest Urology Associates, Morristown, New Jersey 07960, United States

Staten Island Urological Research, PC, Staten Island, New York 10304, United States

Northeast Urology Research, Concord, North Carolina 28025, United States

University of North Carolina, Chapel Hill, Chapel Hill, North Carolina 27599, United States

Washington Urological Associates, Washington, North Carolina 27889, United States

American Health Research, Charlotte, North Carolina 28207, United States

Columbus Urology Research, Columbus, Ohio 43214, United States

Parkhurst Research Organization, Bethany, Oklahoma 73008, United States

Triangle Urological Group, Pittsburgh, Pennsylvania 15212, United States

Dr. Peter Sinaiko, Langhorne, Pennsylvania 19047, United States

Bryn Mawr Urology, Devon, Pennsylvania 19333, United States

Urology and Urological Oncology, Philadelphia, Pennsylvania 19141, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina 29572, United States

Dr. Greg Echt, Irving, Texas 75062, United States

Roger D. Fincher, MD, Spokane, Washington 99202, United States

North West Prostate Institute, Seattle, Washington 98133, United States

Starting date: June 2004
Ending date: December 2008
Last updated: September 18, 2006