The Plenaxis® Experience Study

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00103623
• Other study ID #: 149-IV-01
• Status: Suspended
• Phase: Phase 4
• First received: February 11, 2005
• Last updated: September 18, 2006
• Start date: June 2004
• Est. completion date: December 2008

Study information

• Verified date: September 2006
• Source: PRAECIS Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 2000
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Plenaxis

Locations

Country	Name	City	State
United States	Alfred Sidhom, MD, FACS, PC	Anaheim	California
United States	Dr. Chris Threatt	Atherton	California
United States	Parkhurst Research Organization	Bethany	Oklahoma
United States	Millenium Therapeutics & Research - Urology Practice	Birmingham	Alabama
United States	Essex-Hudson Urology	Bloomfield	New Jersey
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	American Health Research	Charlotte	North Carolina
United States	Midwest Prostate Urology Health Center	Chicago	Illinois
United States	Praire Medical Associates, LTD	Chicago	Illinois
United States	Columbus Urology Research	Columbus	Ohio
United States	Northeast Urology Research	Concord	North Carolina
United States	Heartland Oncology and Hematology	Council Bluffs	Iowa
United States	Urology Associates PC	Denver	Colorado
United States	Bryn Mawr Urology	Devon	Pennsylvania
United States	Private Practice	Emporia	Kansas
United States	Hunterdon Urological Associates, PA	Flemington	New Jersey
United States	Urologic Associates	Fort Meyers	Florida
United States	Southwest Florida Urologic Associates	Fort Myers	Florida
United States	Hematology-Oncology Group of Fresno	Fresno	California
United States	Valley Urologic Associates	Goodyear	Arizona
United States	Midwest Urology	Independence	Missouri
United States	Urology of Indiana	Indianapolis	Indiana
United States	Dr. Greg Echt	Irving	Texas
United States	University of Florida Shands Jacksonville	Jacksonville	Florida
United States	Kansas City Urology Care	Kansas City	Missouri
United States	KUMC Department of Urology	Kansas City	Kansas
United States	Unity HealthCare DBA Lafayette Clinic of Urology	Lafayette	Indiana
United States	South Orange County Medical Research Center	Laguna Woods	California
United States	Dr. Peter Sinaiko	Langhorne	Pennsylvania
United States	Sheldon j. Freedman, MD Ltd	Las Vegas	Nevada
United States	Atlantic Urological Medical Group	Long Beach	California
United States	Urology Associates, P.C.	Marietta	Georgia
United States	Tri-County Urology	Milford	Massachusetts
United States	Northwest Urology Associates	Morristown	New Jersey
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates of Ocala, P.A.	Ocala	Florida
United States	UroSearch	Ocala	Florida
United States	Quality Clinical Research, LLC	Omaha	Nebraska
United States	South Florida Urology Center Inc	Pembroke Pines	Florida
United States	South Florida Urology Center, Inc.	Pembroke Pines	Florida
United States	Urology and Urological Oncology	Philadelphia	Pennsylvania
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Triangle Urological Group	Pittsburgh	Pennsylvania
United States	Paul Neustein, MD. INC	Poway	California
United States	Roseland Surgical Suite	Roseland	New Jersey
United States	San Diego Urology	San Diego	California
United States	North West Prostate Institute	Seattle	Washington
United States	Sherman Oaks Urological Medical Group, Inc.	Sherman Oaks	California
United States	Tewodros Fresseha MD PC	Southfield	Michigan
United States	Roger D. Fincher, MD	Spokane	Washington
United States	Lakeside Urology	St. Joseph	Michigan
United States	Staten Island Urological Research, PC	Staten Island	New York
United States	Uro-Medix, Inc	Sunrise	Florida
United States	Osvaldo F. Padron MD, FACS	Tampa	Florida
United States	Urological Surgical Services	Tavares	Florida
United States	Arizona Urologic Specialists	Tucson	Arizona
United States	Washington Urological Associates	Washington	North Carolina
United States	Bay State Clinical Trials Inc	Watertown	Massachusetts
United States	Osler Medical	West Melbourne	Florida
United States	Urology Healthcare Associates/Rancocas Medical Center	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
PRAECIS Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis