Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)
1 other identifier
interventional
1,589
3 countries
138
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2005
Longer than P75 for phase_3
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 29, 2005
CompletedFirst Posted
Study publicly available on registry
March 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
June 12, 2023
CompletedJune 12, 2023
May 1, 2023
5.1 years
March 29, 2005
April 5, 2013
May 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)
To measure the efficacy of toremifene citrate in men with high grade prostatic intraepithelial neoplasia (PIN). Prostate cancer-free survival distributions (Kaplan-Meier)
The outcome measurement time is up to 36 months
Occurrence of a Positive Cancer Biopsy
To measure the occurrence of a positive cancer biopsy
Up to 36 months
Secondary Outcomes (6)
The Effect of Toremifene on Lipid Levels
Up to 36 months
The Effect of Toremifene on Hormone Levels
Up to 36 months
The Effect of Toremifene on Total PSA (Prostate Specific Antigen) Levels
Up to 36 months
The Effect of Toremifene on the Mean Change at 36 Months in AUA (American Urological Association) Symptom Score
36 months
Occurrence of High Grade PIN at the 12, 24, 36 Month Biopsies
Up to 36 months
- +1 more secondary outcomes
Study Arms (2)
20 mg Toremifene Citrate
EXPERIMENTALThe subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).
Placebo
EXPERIMENTALThe subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days
Interventions
The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).
The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GTxlead
Study Sites (138)
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.
St 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, T5H4B9, Canada
Southern Interior Medical Research Inc.
Kelowna, British Columbia, V1H 2H4, Canada
Dr. G. Steinhoff Clinical Research
Victoria, British Columbia, V8V3N1, Canada
Allan B. Patrick, M.D. Professional corporation
Fredericton, New Brunswick, E3B5B8, Canada
Queen Elizabeth Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1, Canada
Burlington Urology
Burlington, Ontario, L7N 3V2, Canada
Centre for Advanced Urological Research
Kingston, Ontario, K7L 3J7, Canada
Urology Assoc./Urologic Medical Research
Kitchener, Ontario, N2N 2B9, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Mor Urology
Newmarket, Ontario, L3X 1W1, Canada
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
Urotec
Oshawa, Ontario, L1H 7K4, Canada
The Health Institute for Men
Toronto, Ontario, M1P 2T7, Canada
Stanley Flax Medical Professional Corp.
Toronto, Ontario, M3B 3S6, Canada
Univ. Health Network, Princess Margaret Hospital Prostate Centre
Toronto, Ontario, M5G 2M9, Canada
The Male Health Centre
Toronto, Ontario, M6A 3B5, Canada
Roger Buckley, MD
Willowdale, Ontario, M2K 2W1, Canada
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3, Canada
Les Urologues Associes du CHUM
Montreal, Quebec, H2X 1N8, Canada
McGill Urology Associates
Montreal, Quebec, H3S 1Z1, Canada
Ultra-Med, Inc.
Pointe-Claire, Quebec, H9R 4S3, Canada
G.R.U.M.
Trois-Rivières, Quebec, G9A 3V7, Canada
Related Publications (1)
Taneja SS, Morton R, Barnette G, Sieber P, Hancock ML, Steiner M. Prostate cancer diagnosis among men with isolated high-grade intraepithelial neoplasia enrolled onto a 3-year prospective phase III clinical trial of oral toremifene. J Clin Oncol. 2013 Feb 10;31(5):523-9. doi: 10.1200/JCO.2012.41.7634. Epub 2013 Jan 7.
PMID: 23295793DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Operations
- Organization
- GTx, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Samir Taneja, MD
NYU Langone Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2005
First Posted
March 30, 2005
Study Start
January 1, 2005
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
June 12, 2023
Results First Posted
June 12, 2023
Record last verified: 2023-05