Know Cancer

or
forgot password

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 CenterBoston, Massachusetts  02215
Medical College of WisconsinMilwaukee, Wisconsin  53226
Franklin Square Hospital CenterBaltimore, Maryland  21237
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Arlington Cancer CenterArlington, Texas  76012
San Diego Urology CenterLa Mesa, California  91942
Virginia Urology CenterRichmond, Virginia  23230
Washington Hospital CenterWashington, District of Columbia  20010
Texas Cancer CareFort Worth, Texas  76104
University of PittsburghPittsburgh, Pennsylvania  15261
South Florida Medical ResearchAventura, Florida  33180
North Idaho UrologyCouer D'Alene, Idaho  83814
Pacific Clinical ResearchSanta Monica, California  90404
Connecticut Clinical Research CenterWaterbury, Connecticut  06708-2652
Advanced Research InstituteNew Port Richey, Florida  34652
Midwest Research Specialists, LLCMilwaukee, Wisconsin  53209
Charleston Cancer CenterCharleston, South Carolina  29406
AccuMed Research AssociatesGarden City, New York  11530
Columbia Presbyterian Medical CenterNew York, New York  10032
Urology Centers Of AlabamaHomewood,, Alabama  35205
Western Clinical Research, Inc.Torrance,, California  90505-4763
Urologic Associates, PcDavenport, Iowa  52807
Nyack HospitalNyack, New York  10960
The Urology CenterGreensboro,, North Carolina  27401
University Of VermontBurlington,, Vermont  05403
Georgetown University Medical CenterWashington, District of Columbia  20007
Salt Lake ResearchSalt Lake City, Utah  84124
McGuire Research InstituteRichmond, Virginia  
Urology Associates Of Central CaliforniaFresno, California  93720
Atlantic Urology Medical GroupLong Beach, California  90806
Lawrenceville UrologyLawrenceville, New Jersey  08648
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Alaska Clinical Research CenterAnchorage, Alaska  99508
The Urological Institute of Northeastern New YorkAlbany, New York  12208
Texas Cancer CenterAbilene, Texas  79606
Loma Linda UniversityLoma Linda, California  92354
UCHSC Anschutz Cancer PavilionAurora, Colorado  80010
Midtown UrologyAtlanta, Georgia  30308
Prairie Medical Associates, Ltd.Chicago, Illinois  60616
Medical and Surgical SpecialistsGalesburg, Illinois  61401
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Carle Clinic Cancer CenterUrbana, Illinois  61801
Metropolitan UrologyJeffersonville, Indiana  47130
Urology Group of New MexicoAlbuquerque, New Mexico  87109
Urology Associates Clinical ResearchNashville, Tennessee  37209
Urology Clinic of North Texas, PADallas, Texas  75231
Wyoming Research Foundation, Inc.Cheyenne, Wyoming  82001