Prostate Cancer Clinical Trial

Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)

Summary

The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).

View Full Description

Full Description

The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia. Men who have ever been diagnosed with high grade PIN will be enrolled into an 36 month trial and will be assigned to either 20 mg of study drug or placebo per day. Subjects will undergo safety evaluations at Month 3, Month 6, Month 12, Month 18, Month 24, Month 30 and Month 36 along with prostate biopsies at Month 12 and Month 24 and Month 36 to determine efficacy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Give voluntary signed informed consent in accordance with institutional policies
Be male, aged ≥ 30 years
Have a diagnosis of high grade PIN from any previous prostate biopsy. The diagnosis of high grade PIN must be confirmed by the central pathologist
Have had a prostate biopsy in the last 6 months with a minimum of 10 cores that shows no evidence of cancer as confirmed by the central pathologist; OR, have had 2 prostate biopsies (each with a minimum of 6 cores) in the 12 months prior to screening with at least one of the biopsies occurring within 6 months prior to the screening visit. Both biopsies should have no evidence of cancer as confirmed by the central pathologist
Have a serum PSA of ≤ 10 ng/mL
Agree to provide tablet containers for tablet counts and to complete a daily diary of study drug intake
Agree to use an effective method of contraception, if the partner is of child-bearing age, while on study and for 30 days after the last dose of study medication

Have adequate bone marrow, liver and renal function:

White Blood Cell (WBC) Count ≥ 3,000/mm3;
Platelet Count ≥ 100,000/mm3;
Bilirubin ≤ 1.5 mg/dL;
AST and ALT < 2x upper limit of normal;
Serum Creatinine ≤ 2.0 mg%

Exclusion Criteria:

Previous exposure to toremifene citrate
Have evidence of prostate cancer (local, regional and/or distal metastasis)
Have any history of other malignancies (Exceptions include non-melanoma skin cancer or other cancer that has no evidence of tumor reoccurrence 5 years after definitive treatment).
Have active systemic viral, bacterial, or fungal infections requiring treatment
Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
Concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to screening
Currently taking dutasteride. Subject is eligible if he stops dutasteride for a total washout of 90 days prior to the Screening Visit and agrees not to use dutasteride for the duration of the study.
Have previously taken finasteride for greater than two years
Currently taking finasteride. Subject is eligible if he stops finasteride for a total washout of 30 days prior to the Screening Visit and agrees not to use finasteride for the duration of the study.
Currently taking testosterone or testosterone-like supplements, such as dehydroepiandrosterone (DHEA). Subject is eligible if he stops these agents for a total washout of 30 days prior to the Screening Visit and agrees not to use these agents for the duration of the study.
Have a history of taking PC-SPES within the past two years.
Currently taking herbal medicine or dietary supplements for prostate health, such as Saw Palmetto (also known as Serenoa Repens).

Subject is eligible if he stops these agents for a total washout of 30 days prior to taking the first dose of study drug and agrees not to use these agents for the duration of the study.

Lycopene, vitamin E and selenium are not prohibited and no washout is required. However, vitamin E intake should be limited to less than 400 i.u. per day.

Have a history of thromboembolic event or disease including deep vein thrombosis, pulmonary embolus, or thrombotic stroke
History of chronic hepatitis or cirrhosis

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1589

Study ID:

NCT00106691

Recruitment Status:

Completed

Sponsor:

GTx

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 126 Locations for this study

See Locations Near You

Medical Affiliated Research Ctr.
Huntsville Alabama, 35801, United States
Coastal Clinical Research
Mobile Alabama, 36608, United States
Hope Research Inst.
Phoenix Arizona, 85032, United States
Arkansas Urology
Little Rock Arkansas, 72211, United States
San Bernardino Urological Associates Medical Group
San Bernardino California, 92404, United States
Western Clinical Research, Inc.
Torrance California, 90505, United States
Urology Research Options
Aurora Colorado, 80012, United States
Urology Associates, P.C.
Denver Colorado, 80210, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Connecticut Surgical Group
Hartford Connecticut, 06106, United States
Urological Associates of Bridgeport
Trumbull Connecticut, 06611, United States
Connecticut Clinical Research
Waterbury Connecticut, 06708, United States
South Florida Medical Research
Aventura Florida, 33180, United States
Atlantic Urological Associates
Daytona Beach Florida, 32114, United States
Southwest Florida Urologic Associates
Fort Myers Florida, 33907, United States
Advanced Research Institute
New Port Richey Florida, 34652, United States
UroSearch
Ocala Florida, 34471, United States
Central Florida Urology Group/ UroSearch
Ocala Florida, 34474, United States
Florida Foundation for Healthcare Research
Ocala Florida, 34474, United States
Winter Park Urology Associates
Orlando Florida, 32803, United States
Panama City Urological Center
Panama City Florida, 32405, United States
Demaur Clinical Research Center
Pembroke Pines Florida, 33028, United States
DMI Research
Pinellas Park Florida, 33782, United States
Urology Consultants
Pinellas Park Florida, 33782, United States
Florida Urology Specialists
Sarasota Florida, 34237, United States
Midtown Urology
Atlanta Georgia, 30308, United States
Georgia Urology
Atlanta Georgia, 30342, United States
Urology Enterprises
Marietta Georgia, 30060, United States
North Fulton Urology
Roswell Georgia, 30076, United States
St. Joseph's, Candler Health System
Savannah Georgia, 31405, United States
Specialty Care Research
Peoria Illinois, 61614, United States
Urology of Indiana, LLC
Indianapolis Indiana, 46254, United States
Metropolitan Urology, PSC
Jeffersonville Indiana, 47130, United States
Kansas City Urology Care, P.C.
Overland Park Kansas, 66211, United States
Regional Urology, LLC
Shreveport Louisiana, 71106, United States
Anne Arundel Urology
Annapolis Maryland, 21401, United States
Maryland Prostate Center: University of Maryland Medical Center
Baltimore Maryland, 21201, United States
Drs. Werner, Murdock, & Francis PA, Urology Associates
Greenbelt Maryland, 20770, United States
Urology Center, PA
Hagerstown Maryland, 21742, United States
Mid Atlantic Clinical Research
Rockville Maryland, 28050, United States
Chesapeake Urology Research Assoc.
Towson Maryland, 21204, United States
Brigham & Women's Hospital, Division of Urological Surgery
Boston Massachusetts, 02115, United States
Boston Clinical Trials
Brighton Massachusetts, 02135, United States
Michigan Medical, PC Urology
Grand Rapids Michigan, 49546, United States
Mich. Inst. of Urology
Saint Clair Shores Michigan, 48081, United States
Adult & Pediatric Urology
Sartell Minnesota, 56377, United States
St. Louis Urological Surgeons
Chesterfield Missouri, 63017, United States
Metropolitan Urological Specialists
Florissant Missouri, 63031, United States
Midwest Urology Center
Independence Missouri, 64055, United States
Washington University Urologic Research Ctr.
Saint Louis Missouri, 63110, United States
Urology PC
Lincoln Nebraska, 68516, United States
Sheldon Freeman
Las Vegas Nevada, 89109, United States
Urologic Surgeons, Ltd.
Reno Nevada, 89502, United States
Coastal Urology Associates
Brick New Jersey, 08724, United States
Central Jersey Clinical Research
Edison New Jersey, 08837, United States
Hamilton Urology PA
Hamilton New Jersey, 08690, United States
Delaware Valley Urology
Marlton New Jersey, 08053, United States
Delaware Valley Urology
Mount Laurel New Jersey, 08054, United States
Urology Group of New Mexico
Albuquerque New Mexico, 87109, United States
The Urological Institute of Northeastern Research Department
Albany New York, 12208, United States
Metropolitan Urologic Services, P.C.
Elmont New York, 11003, United States
AccuMed Research Associates
Garden City New York, 11530, United States
Urological Surgeons of Long Island
Garden City New York, 11530, United States
Lake Success Urological Associates
Lake Success New York, 11042, United States
Urology Associates, PC
Manhasset New York, 11030, United States
NYU Urology Associates
New York New York, 10016, United States
University Urology Associates
New York New York, 10016, United States
CNY Urology
Oneida New York, 13421, United States
Staten Island Urological Research
Staten Island New York, 10304, United States
Asheboro Urology Clinic
Asheboro North Carolina, 27203, United States
McKay Urology
Charlotte North Carolina, 28204, United States
Wake Urology Associates
Raleigh North Carolina, 27607, United States
Summa Health System, Cancer Research Office
Akron Ohio, 44304, United States
Tri-State Urologic Services/PSC, Inc. d/b/a The Urology Group
Cincinnati Ohio, 45212, United States
Capital Urology
Columbus Ohio, 43214, United States
Columbus Urology, Inc.
Columbus Ohio, 43214, United States
Urology of Northern Ohio
Elyria Ohio, 44035, United States
Southwest Urology
Middleburg Heights Ohio, 44130, United States
Parkhurst Research Organization
Bethany Oklahoma, 73008, United States
Urologic Specialists of Oklahoma Research Department
Tulsa Oklahoma, 74104, United States
Oregon Urology Specialists
Springfield Oregon, 97477, United States
Urologic Associates of Allentown
Allentown Pennsylvania, 18103, United States
Urologic Surgery, P.C.
Bala-Cynwyd Pennsylvania, 19004, United States
Urological Associates of Lancaster, Ltd.
Lancaster Pennsylvania, 17604, United States
The Urology Institute
Monroeville Pennsylvania, 15146, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Triangle Urological Group
Pittsburgh Pennsylvania, 15212, United States
University of Pittsburgh, Department of Urology
Pittsburgh Pennsylvania, 15232, United States
State College Urologic Associates, Inc.
State College Pennsylvania, 16801, United States
University Urological Research Institute
Providence Rhode Island, 02904, United States
Columbia Urological Associates
Columbia South Carolina, 29201, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
Urology Center of the South
Germantown Tennessee, 38138, United States
Volunteer Research Group
Knoxville Tennessee, 37920, United States
Southeast Urology Network
Memphis Tennessee, 38119, United States
University of Tennessee, Dept. of Urology
Memphis Tennessee, 38163, United States
Urology Associates
Nashville Tennessee, 37209, United States
Professional Quality Research
Austin Texas, 78756, United States
Research Across America
Dallas Texas, 75234, United States
Urology San Antonio Research, PA
San Antonio Texas, 78229, United States
Advanced Clinical Research
Salt Lake City Utah, 84102, United States
Salt Lake Research
Salt Lake City Utah, 84107, United States
Devine-Tidewater Urology
Norfolk Virginia, 23502, United States
Med Atlantic, Inc (Virginia Urology)
Richmond Virginia, 23235, United States
Seattle Urological Associates
Seattle Washington, 98104, United States
Deaconess Medical Center
Spokane Washington, 99204, United States
Urologic Northwest Surgeons
Tacoma Washington, 98405, United States
Urology Services Madigan Army Medical Center
Tacoma Washington, 98431, United States
Centro Urologico Buenos Aires
Buenos Aires , , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires , , Argentina
Hospital Pirovano
Buenos Aires , , Argentina
Policlinico Bancario de Buenos Aires
Buenos Aires , , Argentina
Sanatorio Municipal
Buenos Aires , , Argentina
Servicio de Urologia
Buenos Aires , , Argentina
Prostate Cancer Inst.
Calgary Alberta, , Canada
Alberta Urology Inst.. Research Center
Edmonton Alberta, T5H4B, Canada
Southern Interior Medical Research Inc.
Kelowna British Columbia, V1H 2, Canada
Dr. G. Steinhoff Clinical Research
Victoria British Columbia, V8V3N, Canada
Allan B. Patrick, M.D. Professional corporation
Fredericton New Brunswick, E3B5B, Canada
Queen Elizabeth Health Sciences Centre
Halifax Nova Scotia, B3H 1, Canada
Male/Female Health and Research Centre
Barrie Ontario, L4M 7, Canada
Burlington Urology
Burlington Ontario, L7N 3, Canada
Centre for Advanced Urological Research
Kingston Ontario, K7L 3, Canada
Urology Assoc./Urologic Medical Research
Kitchener Ontario, N2N 2, Canada
London Health Sciences Centre
London Ontario, N6A 5, Canada
Mor Urology
Newmarket Ontario, L3X 1, Canada
The Fe/Male Health Centres
Oakville Ontario, L6H 3, Canada
Urotec
Oshawa Ontario, L1H 7, Canada
The Health Institute for Men
Toronto Ontario, M1P 2, Canada
Stanley Flax Medical Professional Corp.
Toronto Ontario, M3B 3, Canada
Univ. Health Network, Princess Margaret Hospital Prostate Centre
Toronto Ontario, M5G 2, Canada
The Male Health Centre
Toronto Ontario, M6A 3, Canada
Roger Buckley, MD
Willowdale Ontario, M2K 2, Canada
Urology South Shore Research
Greenfield Park Quebec, J4V 2, Canada
Les Urologues Associes du CHUM
Montreal Quebec, H2X 1, Canada
McGill Urology Associates
Montreal Quebec, H3S 1, Canada
Ultra-Med, Inc.
Pointe Claire Quebec, H9R 4, Canada
G.R.U.M.
Trois-Rivieres Quebec, G9A 3, Canada

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

1589

Study ID:

NCT00106691

Recruitment Status:

Completed

Sponsor:


GTx

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.