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A Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC®-VF/TRICOM™ in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

A Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC®-VF/TRICOM™ in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate

Inclusion Criteria


- Male patients > 18 years of age who have been vaccinated against smallpox;

- Histological confirmation of adenocarcinoma of the prostate with evidence of
metastatic disease including either of the following: Lymph node metastasis
measurable by CT and/or Bone metastasis evaluable by bone scan;

- Despite hormone therapy, there is evidence of two consecutive increases in PSA
(Prostate Specific Antigen);

- Gleason Score of 7 or lower at initial diagnosis.

Please note that there are additional eligibility criteria that you must meet to qualify.

If you do qualify to participate, study personnel will explain the trial in detail and
answer any questions you may have. You can then decide whether or not you wish to
participate. If you do not qualify for the trial, study personnel will explain the
reasons.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

TBC-PRO-002

NCT ID:

NCT00078585

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Franklin Square Hospital Center Baltimore, Maryland  21237
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Arlington Cancer Center Arlington, Texas  76012
San Diego Urology Center La Mesa, California  91942
Virginia Urology Center Richmond, Virginia  23230
Washington Hospital Center Washington, District of Columbia  20010
Texas Cancer Care Fort Worth, Texas  76104
University of Pittsburgh Pittsburgh, Pennsylvania  15261
South Florida Medical Research Aventura, Florida  33180
North Idaho Urology Couer D'Alene, Idaho  83814
Pacific Clinical Research Santa Monica, California  90404
Connecticut Clinical Research Center Waterbury, Connecticut  06708-2652
Advanced Research Institute New Port Richey, Florida  34652
Midwest Research Specialists, LLC Milwaukee, Wisconsin  53209
Charleston Cancer Center Charleston, South Carolina  29406
AccuMed Research Associates Garden City, New York  11530
Columbia Presbyterian Medical Center New York, New York  10032
Urology Centers Of Alabama Homewood,, Alabama  35205
Western Clinical Research, Inc. Torrance,, California  90505-4763
Urologic Associates, Pc Davenport, Iowa  52807
Nyack Hospital Nyack, New York  10960
The Urology Center Greensboro,, North Carolina  27401
University Of Vermont Burlington,, Vermont  05403
Georgetown University Medical Center Washington, District of Columbia  20007
Salt Lake Research Salt Lake City, Utah  84124
McGuire Research Institute Richmond, Virginia  
Urology Associates Of Central California Fresno, California  93720
Atlantic Urology Medical Group Long Beach, California  90806
Lawrenceville Urology Lawrenceville, New Jersey  08648
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Alaska Clinical Research Center Anchorage, Alaska  99508
The Urological Institute of Northeastern New York Albany, New York  12208
Texas Cancer Center Abilene, Texas  79606
Loma Linda University Loma Linda, California  92354
UCHSC Anschutz Cancer Pavilion Aurora, Colorado  80010
Midtown Urology Atlanta, Georgia  30308
Prairie Medical Associates, Ltd. Chicago, Illinois  60616
Medical and Surgical Specialists Galesburg, Illinois  61401
OSF Saint Francis Medical Center Peoria, Illinois  61637
Carle Clinic Cancer Center Urbana, Illinois  61801
Metropolitan Urology Jeffersonville, Indiana  47130
Urology Group of New Mexico Albuquerque, New Mexico  87109
Urology Associates Clinical Research Nashville, Tennessee  37209
Urology Clinic of North Texas, PA Dallas, Texas  75231
Wyoming Research Foundation, Inc. Cheyenne, Wyoming  82001