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The Plenaxis® Experience Study

Primary Purpose

Prostate Cancer

Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Plenaxis
Sponsored by
PRAECIS Pharmaceuticals Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Advanced, Symptomatic, Prostate, Cancer, Advanced Symptomatic Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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: Risk of neurological compromise due to metastases, Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or 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

Sites / Locations

  • Millenium Therapeutics & Research - Urology Practice
  • Valley Urologic Associates
  • Foundation for Cancer Research and Education
  • Arizona Urologic Specialists
  • Alfred Sidhom, MD, FACS, PC
  • Dr. Chris Threatt
  • Hematology-Oncology Group of Fresno
  • South Orange County Medical Research Center
  • Atlantic Urological Medical Group
  • Paul Neustein, MD. INC
  • San Diego Urology
  • Sherman Oaks Urological Medical Group, Inc.
  • Urology Associates PC
  • Urologic Associates
  • Southwest Florida Urologic Associates
  • University of Florida Shands Jacksonville
  • UroSearch
  • Urology Associates of Ocala, P.A.
  • South Florida Urology Center Inc
  • South Florida Urology Center, Inc.
  • Uro-Medix, Inc
  • Osvaldo F. Padron MD, FACS
  • Urological Surgical Services
  • Osler Medical
  • Urology Associates, P.C.
  • Praire Medical Associates, LTD
  • Midwest Prostate Urology Health Center
  • Urology of Indiana
  • Unity HealthCare DBA Lafayette Clinic of Urology
  • Heartland Oncology and Hematology
  • Private Practice
  • KUMC Department of Urology
  • Tri-County Urology
  • Bay State Clinical Trials Inc
  • Tewodros Fresseha MD PC
  • Lakeside Urology
  • Midwest Urology
  • Kansas City Urology Care
  • Quality Clinical Research, LLC
  • Sheldon j. Freedman, MD Ltd
  • Essex-Hudson Urology
  • Hunterdon Urological Associates, PA
  • Northwest Urology Associates
  • Roseland Surgical Suite
  • Urology Healthcare Associates/Rancocas Medical Center
  • Staten Island Urological Research, PC
  • University of North Carolina, Chapel Hill
  • American Health Research
  • Northeast Urology Research
  • Washington Urological Associates
  • Columbus Urology Research
  • Parkhurst Research Organization
  • Bryn Mawr Urology
  • Dr. Peter Sinaiko
  • Urology and Urological Oncology
  • Triangle Urological Group
  • Carolina Urologic Research Center
  • Dr. Greg Echt
  • North West Prostate Institute
  • Roger D. Fincher, MD

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 11, 2005
Last Updated
September 18, 2006
Sponsor
PRAECIS Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00103623
Brief Title
The Plenaxis® Experience Study
Official Title
Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Suspended
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
PRAECIS Pharmaceuticals Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Advanced, Symptomatic, Prostate, Cancer, Advanced Symptomatic Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Plenaxis
Primary Outcome Measure Information:
Title
Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Risk of neurological compromise due to metastases, Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerald Riedel, PhD
Organizational Affiliation
PRAECIS Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Millenium Therapeutics & Research - Urology Practice
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Valley Urologic Associates
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Arizona Urologic Specialists
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Alfred Sidhom, MD, FACS, PC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Dr. Chris Threatt
City
Atherton
State/Province
California
ZIP/Postal Code
94027
Country
United States
Facility Name
Hematology-Oncology Group of Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
South Orange County Medical Research Center
City
Laguna Woods
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Atlantic Urological Medical Group
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Paul Neustein, MD. INC
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
San Diego Urology
City
San Diego
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Sherman Oaks Urological Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Urology Associates PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Urologic Associates
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
Southwest Florida Urologic Associates
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
University of Florida Shands Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
UroSearch
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Urology Associates of Ocala, P.A.
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
South Florida Urology Center Inc
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
South Florida Urology Center, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Uro-Medix, Inc
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Osvaldo F. Padron MD, FACS
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Urological Surgical Services
City
Tavares
State/Province
Florida
ZIP/Postal Code
32778
Country
United States
Facility Name
Osler Medical
City
West Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Urology Associates, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Praire Medical Associates, LTD
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Midwest Prostate Urology Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Urology of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Unity HealthCare DBA Lafayette Clinic of Urology
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Heartland Oncology and Hematology
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Private Practice
City
Emporia
State/Province
Kansas
ZIP/Postal Code
66801
Country
United States
Facility Name
KUMC Department of Urology
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Tri-County Urology
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Bay State Clinical Trials Inc
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Tewodros Fresseha MD PC
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Lakeside Urology
City
St. Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Midwest Urology
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Kansas City Urology Care
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Quality Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Sheldon j. Freedman, MD Ltd
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Essex-Hudson Urology
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Hunterdon Urological Associates, PA
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Northwest Urology Associates
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Roseland Surgical Suite
City
Roseland
State/Province
New Jersey
ZIP/Postal Code
07068
Country
United States
Facility Name
Urology Healthcare Associates/Rancocas Medical Center
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Staten Island Urological Research, PC
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
Facility Name
University of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
American Health Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Northeast Urology Research
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Washington Urological Associates
City
Washington
State/Province
North Carolina
ZIP/Postal Code
27889
Country
United States
Facility Name
Columbus Urology Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Parkhurst Research Organization
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
Bryn Mawr Urology
City
Devon
State/Province
Pennsylvania
ZIP/Postal Code
19333
Country
United States
Facility Name
Dr. Peter Sinaiko
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Urology and Urological Oncology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Triangle Urological Group
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Dr. Greg Echt
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
North West Prostate Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Roger D. Fincher, MD
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Plenaxis® Experience Study

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