The Plenaxis® Experience Study

NCT ID: NCT00103623

Last Updated: 2006-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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Advanced Symptomatic Prostate Cancer Advanced Symptomatic Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Plenaxis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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PRAECIS Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Gerald Riedel, PhD

Role: STUDY_DIRECTOR

PRAECIS Pharmaceuticals Inc.

Locations

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Millenium Therapeutics & Research - Urology Practice

Birmingham, Alabama, United States

Site Status

Valley Urologic Associates

Goodyear, Arizona, United States

Site Status

Foundation for Cancer Research and Education

Phoenix, Arizona, United States

Site Status

Arizona Urologic Specialists

Tucson, Arizona, United States

Site Status

Alfred Sidhom, MD, FACS, PC

Anaheim, California, United States

Site Status

Dr. Chris Threatt

Atherton, California, United States

Site Status

Hematology-Oncology Group of Fresno

Fresno, California, United States

Site Status

South Orange County Medical Research Center

Laguna Woods, California, United States

Site Status

Atlantic Urological Medical Group

Long Beach, California, United States

Site Status

Paul Neustein, MD. INC

Poway, California, United States

Site Status

San Diego Urology

San Diego, California, United States

Site Status

Sherman Oaks Urological Medical Group, Inc.

Sherman Oaks, California, United States

Site Status

Urology Associates PC

Denver, Colorado, United States

Site Status

Urologic Associates

Fort Meyers, Florida, United States

Site Status

Southwest Florida Urologic Associates

Fort Myers, Florida, United States

Site Status

University of Florida Shands Jacksonville

Jacksonville, Florida, United States

Site Status

UroSearch

Ocala, Florida, United States

Site Status

Urology Associates of Ocala, P.A.

Ocala, Florida, United States

Site Status

South Florida Urology Center Inc

Pembroke Pines, Florida, United States

Site Status

South Florida Urology Center, Inc.

Pembroke Pines, Florida, United States

Site Status

Uro-Medix, Inc

Sunrise, Florida, United States

Site Status

Osvaldo F. Padron MD, FACS

Tampa, Florida, United States

Site Status

Urological Surgical Services

Tavares, Florida, United States

Site Status

Osler Medical

West Melbourne, Florida, United States

Site Status

Urology Associates, P.C.

Marietta, Georgia, United States

Site Status

Praire Medical Associates, LTD

Chicago, Illinois, United States

Site Status

Midwest Prostate Urology Health Center

Chicago, Illinois, United States

Site Status

Urology of Indiana

Indianapolis, Indiana, United States

Site Status

Unity HealthCare DBA Lafayette Clinic of Urology

Lafayette, Indiana, United States

Site Status

Heartland Oncology and Hematology

Council Bluffs, Iowa, United States

Site Status

Private Practice

Emporia, Kansas, United States

Site Status

KUMC Department of Urology

Kansas City, Kansas, United States

Site Status

Tri-County Urology

Milford, Massachusetts, United States

Site Status

Bay State Clinical Trials Inc

Watertown, Massachusetts, United States

Site Status

Lakeside Urology

Saint Joseph, Michigan, United States

Site Status

Tewodros Fresseha MD PC

Southfield, Michigan, United States

Site Status

Midwest Urology

Independence, Missouri, United States

Site Status

Kansas City Urology Care

Kansas City, Missouri, United States

Site Status

Quality Clinical Research, LLC

Omaha, Nebraska, United States

Site Status

Sheldon j. Freedman, MD Ltd

Las Vegas, Nevada, United States

Site Status

Essex-Hudson Urology

Bloomfield, New Jersey, United States

Site Status

Hunterdon Urological Associates, PA

Flemington, New Jersey, United States

Site Status

Northwest Urology Associates

Morristown, New Jersey, United States

Site Status

Roseland Surgical Suite

Roseland, New Jersey, United States

Site Status

Urology Healthcare Associates/Rancocas Medical Center

Willingboro, New Jersey, United States

Site Status

Staten Island Urological Research, PC

Staten Island, New York, United States

Site Status

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

American Health Research

Charlotte, North Carolina, United States

Site Status

Northeast Urology Research

Concord, North Carolina, United States

Site Status

Washington Urological Associates

Washington, North Carolina, United States

Site Status

Columbus Urology Research

Columbus, Ohio, United States

Site Status

Parkhurst Research Organization

Bethany, Oklahoma, United States

Site Status

Bryn Mawr Urology

Devon, Pennsylvania, United States

Site Status

Dr. Peter Sinaiko

Langhorne, Pennsylvania, United States

Site Status

Urology and Urological Oncology

Philadelphia, Pennsylvania, United States

Site Status

Triangle Urological Group

Pittsburgh, Pennsylvania, United States

Site Status

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site Status

Dr. Greg Echt

Irving, Texas, United States

Site Status

North West Prostate Institute

Seattle, Washington, United States

Site Status

Roger D. Fincher, MD

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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149-IV-01

Identifier Type: -

Identifier Source: org_study_id