Clinical trial NCT00103623: The Plenaxis® Experience Study
Official title: Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Advanced
Symptomatic
Prostate
Cancer
Advanced Symptomatic Prostate Cancer
Lead sponsor: PRAECIS Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2005-02-14
Enrollment: 2000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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:

  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

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