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

Primary Purpose

Preneoplastic Conditions, Prostatic Intraepithelial Neoplasia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Toremifene 20 mg
Placebo
Sponsored by
GTx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preneoplastic Conditions focused on measuring neoplasia, chemoprevention, cancer, premalignant, precancerous, Chemoprophylaxis, Intraepithelial Prostatic Neoplasia, Neoplasia, Prostatic Intraepithelial

Eligibility Criteria

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

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

Sites / Locations

  • Medical Affiliated Research Ctr.
  • Coastal Clinical Research
  • Hope Research Inst.
  • Arkansas Urology
  • San Bernardino Urological Associates Medical Group
  • Western Clinical Research, Inc.
  • Urology Research Options
  • Urology Associates, P.C.
  • The Urology Center of Colorado
  • Connecticut Surgical Group
  • Urological Associates of Bridgeport
  • Connecticut Clinical Research
  • South Florida Medical Research
  • Atlantic Urological Associates
  • Southwest Florida Urologic Associates
  • Advanced Research Institute
  • UroSearch
  • Central Florida Urology Group/ UroSearch
  • Florida Foundation for Healthcare Research
  • Winter Park Urology Associates
  • Panama City Urological Center
  • Demaur Clinical Research Center
  • DMI Research
  • Urology Consultants
  • Florida Urology Specialists
  • Midtown Urology
  • Georgia Urology
  • Urology Enterprises
  • North Fulton Urology
  • St. Joseph's, Candler Health System
  • Specialty Care Research
  • Urology of Indiana, LLC
  • Metropolitan Urology, PSC
  • Kansas City Urology Care, P.C.
  • Regional Urology, LLC
  • Anne Arundel Urology
  • Maryland Prostate Center: University of Maryland Medical Center
  • Drs. Werner, Murdock, & Francis PA, Urology Associates
  • Urology Center, PA
  • Mid Atlantic Clinical Research
  • Chesapeake Urology Research Assoc.
  • Brigham & Women's Hospital, Division of Urological Surgery
  • Boston Clinical Trials
  • Michigan Medical, PC Urology
  • Mich. Inst. of Urology
  • Adult & Pediatric Urology
  • St. Louis Urological Surgeons
  • Metropolitan Urological Specialists
  • Midwest Urology Center
  • Washington University Urologic Research Ctr.
  • Urology PC
  • Sheldon Freeman
  • Urologic Surgeons, Ltd.
  • Coastal Urology Associates
  • Central Jersey Clinical Research
  • Hamilton Urology PA
  • Delaware Valley Urology
  • Delaware Valley Urology
  • Urology Group of New Mexico
  • The Urological Institute of Northeastern Research Department
  • Metropolitan Urologic Services, P.C.
  • AccuMed Research Associates
  • Urological Surgeons of Long Island
  • Lake Success Urological Associates
  • Urology Associates, PC
  • NYU Urology Associates
  • University Urology Associates
  • CNY Urology
  • Staten Island Urological Research
  • Asheboro Urology Clinic
  • McKay Urology
  • Wake Urology Associates
  • Summa Health System, Cancer Research Office
  • Tri-State Urologic Services/PSC, Inc. d/b/a The Urology Group
  • Capital Urology
  • Columbus Urology, Inc.
  • Urology of Northern Ohio
  • Southwest Urology
  • Parkhurst Research Organization
  • Urologic Specialists of Oklahoma Research Department
  • Oregon Urology Specialists
  • Urologic Associates of Allentown
  • Urologic Surgery, P.C.
  • Urological Associates of Lancaster, Ltd.
  • The Urology Institute
  • University of Pennsylvania
  • Triangle Urological Group
  • University of Pittsburgh, Department of Urology
  • State College Urologic Associates, Inc.
  • University Urological Research Institute
  • Columbia Urological Associates
  • Carolina Urologic Research Center
  • Urology Center of the South
  • Volunteer Research Group
  • Southeast Urology Network
  • University of Tennessee, Dept. of Urology
  • Urology Associates
  • Professional Quality Research
  • Research Across America
  • Urology San Antonio Research, PA
  • Advanced Clinical Research
  • Salt Lake Research
  • Devine-Tidewater Urology
  • Med Atlantic, Inc (Virginia Urology)
  • Seattle Urological Associates
  • Deaconess Medical Center
  • Urologic Northwest Surgeons
  • Urology Services Madigan Army Medical Center
  • Centro Urologico Buenos Aires
  • Hospital Italiano de Buenos Aires
  • Hospital Pirovano
  • Policlinico Bancario de Buenos Aires
  • Sanatorio Municipal
  • Servicio de Urologia
  • Prostate Cancer Inst.
  • Alberta Urology Inst.. Research Center
  • Southern Interior Medical Research Inc.
  • Dr. G. Steinhoff Clinical Research
  • Allan B. Patrick, M.D. Professional corporation
  • Queen Elizabeth Health Sciences Centre
  • Male/Female Health and Research Centre
  • Burlington Urology
  • Centre for Advanced Urological Research
  • Urology Assoc./Urologic Medical Research
  • London Health Sciences Centre
  • Mor Urology
  • The Fe/Male Health Centres
  • Urotec
  • The Health Institute for Men
  • Stanley Flax Medical Professional Corp.
  • Univ. Health Network, Princess Margaret Hospital Prostate Centre
  • The Male Health Centre
  • Roger Buckley, MD
  • Urology South Shore Research
  • Les Urologues Associes du CHUM
  • McGill Urology Associates
  • Ultra-Med, Inc.
  • G.R.U.M.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

20 mg Toremifene Citrate

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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)
Occurrence of a Positive Cancer Biopsy
To measure the occurrence of a positive cancer biopsy

Secondary Outcome Measures

The Effect of Toremifene on Lipid Levels
Measure lipid levels including total cholesterol, LDL, HDL and Triglycerides % change from baseline
The Effect of Toremifene on Hormone Levels
% Change from baseline hormone levels, including total testosterone, free testosterone, dihydrotestosterone (DHT) and estradiol
The Effect of Toremifene on Total PSA (Prostate Specific Antigen) Levels
To assess the effect of toremifene in the total PSA (prostate specific antigen) levels from baseline
The Effect of Toremifene on the Mean Change at 36 Months in AUA (American Urological Association) Symptom Score
To assess the effect of toremifene on the AUA (American Urological Association) symptom score mean change from baseline. Scores of 0-7=mild severity, 8-9, moderate, and 20-30, severe with possible responses of 0 (not at all) 1 (<1/5), 2 (<50% time), 3 (about 50% time), 4 (> 50% time) & 5 (Almost Always). There are 7 questions (1)Incomplete emptying (2)Frequency (3)Intermittency (4)Urgency (5)Weak-stream (6)Straining & (7)Nocturia. Analysis is change from baseline at final evaluation (36 months) for quality of life due to urinary symptoms. The P Value is from a Wilcoxon signed-rank test. Scores can range from 0-35, highest representing worse symptoms
Occurrence of High Grade PIN at the 12, 24, 36 Month Biopsies
To measure the occurrence of high grade PIN at the 12, 24, 36 Month intervals in the 360 days study.
The Effect of Toremifene on % Free Serum PSA (Prostate Specific Antigen) Levels, Change From Baseline
To assess the effect of toremifene in % free serum PSA (prostate specific antigen) levels, change from baseline

Full Information

First Posted
March 29, 2005
Last Updated
May 18, 2023
Sponsor
GTx
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1. Study Identification

Unique Protocol Identification Number
NCT00106691
Brief Title
Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GTx

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preneoplastic Conditions, Prostatic Intraepithelial Neoplasia
Keywords
neoplasia, chemoprevention, cancer, premalignant, precancerous, Chemoprophylaxis, Intraepithelial Prostatic Neoplasia, Neoplasia, Prostatic Intraepithelial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1589 (Actual)

8. Arms, Groups, and Interventions

Arm Title
20 mg Toremifene Citrate
Arm Type
Experimental
Arm Description
The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).
Arm Title
Placebo
Arm Type
Experimental
Arm Description
The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days
Intervention Type
Drug
Intervention Name(s)
Toremifene 20 mg
Intervention Description
The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.
Primary Outcome Measure Information:
Title
Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN)
Description
To measure the efficacy of toremifene citrate in men with high grade prostatic intraepithelial neoplasia (PIN). Prostate cancer-free survival distributions (Kaplan-Meier)
Time Frame
The outcome measurement time is up to 36 months
Title
Occurrence of a Positive Cancer Biopsy
Description
To measure the occurrence of a positive cancer biopsy
Time Frame
Up to 36 months
Secondary Outcome Measure Information:
Title
The Effect of Toremifene on Lipid Levels
Description
Measure lipid levels including total cholesterol, LDL, HDL and Triglycerides % change from baseline
Time Frame
Up to 36 months
Title
The Effect of Toremifene on Hormone Levels
Description
% Change from baseline hormone levels, including total testosterone, free testosterone, dihydrotestosterone (DHT) and estradiol
Time Frame
Up to 36 months
Title
The Effect of Toremifene on Total PSA (Prostate Specific Antigen) Levels
Description
To assess the effect of toremifene in the total PSA (prostate specific antigen) levels from baseline
Time Frame
Up to 36 months
Title
The Effect of Toremifene on the Mean Change at 36 Months in AUA (American Urological Association) Symptom Score
Description
To assess the effect of toremifene on the AUA (American Urological Association) symptom score mean change from baseline. Scores of 0-7=mild severity, 8-9, moderate, and 20-30, severe with possible responses of 0 (not at all) 1 (<1/5), 2 (<50% time), 3 (about 50% time), 4 (> 50% time) & 5 (Almost Always). There are 7 questions (1)Incomplete emptying (2)Frequency (3)Intermittency (4)Urgency (5)Weak-stream (6)Straining & (7)Nocturia. Analysis is change from baseline at final evaluation (36 months) for quality of life due to urinary symptoms. The P Value is from a Wilcoxon signed-rank test. Scores can range from 0-35, highest representing worse symptoms
Time Frame
36 months
Title
Occurrence of High Grade PIN at the 12, 24, 36 Month Biopsies
Description
To measure the occurrence of high grade PIN at the 12, 24, 36 Month intervals in the 360 days study.
Time Frame
Up to 36 months
Title
The Effect of Toremifene on % Free Serum PSA (Prostate Specific Antigen) Levels, Change From Baseline
Description
To assess the effect of toremifene in % free serum PSA (prostate specific antigen) levels, change from baseline
Time Frame
36 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir Taneja, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Affiliated Research Ctr.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Coastal Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Hope Research Inst.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
San Bernardino Urological Associates Medical Group
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
Western Clinical Research, Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Urology Research Options
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Urology Associates, P.C.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
The Urology Center of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Connecticut Surgical Group
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Urological Associates of Bridgeport
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Connecticut Clinical Research
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Atlantic Urological Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Southwest Florida Urologic Associates
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
UroSearch
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Central Florida Urology Group/ UroSearch
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Florida Foundation for Healthcare Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Winter Park Urology Associates
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Panama City Urological Center
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Demaur Clinical Research Center
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
DMI Research
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Urology Consultants
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Florida Urology Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
Midtown Urology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Georgia Urology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Urology Enterprises
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
North Fulton Urology
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
St. Joseph's, Candler Health System
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Specialty Care Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Urology of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
Metropolitan Urology, PSC
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Kansas City Urology Care, P.C.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Regional Urology, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Anne Arundel Urology
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Maryland Prostate Center: University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Drs. Werner, Murdock, & Francis PA, Urology Associates
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Urology Center, PA
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Mid Atlantic Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
28050
Country
United States
Facility Name
Chesapeake Urology Research Assoc.
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Brigham & Women's Hospital, Division of Urological Surgery
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Clinical Trials
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Michigan Medical, PC Urology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Mich. Inst. of Urology
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
Adult & Pediatric Urology
City
Sartell
State/Province
Minnesota
ZIP/Postal Code
56377
Country
United States
Facility Name
St. Louis Urological Surgeons
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Metropolitan Urological Specialists
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
Facility Name
Midwest Urology Center
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Washington University Urologic Research Ctr.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Urology PC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Sheldon Freeman
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Urologic Surgeons, Ltd.
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Coastal Urology Associates
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Central Jersey Clinical Research
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Hamilton Urology PA
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Delaware Valley Urology
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Delaware Valley Urology
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Urology Group of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
The Urological Institute of Northeastern Research Department
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Metropolitan Urologic Services, P.C.
City
Elmont
State/Province
New York
ZIP/Postal Code
11003
Country
United States
Facility Name
AccuMed Research Associates
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Urological Surgeons of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Lake Success Urological Associates
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Urology Associates, PC
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University Urology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
CNY Urology
City
Oneida
State/Province
New York
ZIP/Postal Code
13421
Country
United States
Facility Name
Staten Island Urological Research
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
Facility Name
Asheboro Urology Clinic
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
McKay Urology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Wake Urology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Summa Health System, Cancer Research Office
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Tri-State Urologic Services/PSC, Inc. d/b/a The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Capital Urology
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Columbus Urology, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Urology of Northern Ohio
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Southwest Urology
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Parkhurst Research Organization
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
Urologic Specialists of Oklahoma Research Department
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Oregon Urology Specialists
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Urologic Associates of Allentown
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Urologic Surgery, P.C.
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Urological Associates of Lancaster, Ltd.
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
The Urology Institute
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Triangle Urological Group
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh, Department of Urology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
State College Urologic Associates, Inc.
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
University Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Columbia Urological Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
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
Urology Center of the South
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Volunteer Research Group
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Southeast Urology Network
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
University of Tennessee, Dept. of Urology
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Urology Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Professional Quality Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Urology San Antonio Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Devine-Tidewater Urology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Med Atlantic, Inc (Virginia Urology)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Seattle Urological Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Deaconess Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Urologic Northwest Surgeons
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Urology Services Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Centro Urologico Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Pirovano
City
Buenos Aires
Country
Argentina
Facility Name
Policlinico Bancario de Buenos Aires
City
Buenos Aires
Country
Argentina
Facility Name
Sanatorio Municipal
City
Buenos Aires
Country
Argentina
Facility Name
Servicio de Urologia
City
Buenos Aires
Country
Argentina
Facility Name
Prostate Cancer Inst.
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Alberta Urology Inst.. Research Center
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H4B9
Country
Canada
Facility Name
Southern Interior Medical Research Inc.
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1H 2H4
Country
Canada
Facility Name
Dr. G. Steinhoff Clinical Research
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V3N1
Country
Canada
Facility Name
Allan B. Patrick, M.D. Professional corporation
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B5B8
Country
Canada
Facility Name
Queen Elizabeth Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Male/Female Health and Research Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Burlington Urology
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Facility Name
Centre for Advanced Urological Research
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3J7
Country
Canada
Facility Name
Urology Assoc./Urologic Medical Research
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Mor Urology
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3X 1W1
Country
Canada
Facility Name
The Fe/Male Health Centres
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Urotec
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 7K4
Country
Canada
Facility Name
The Health Institute for Men
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1P 2T7
Country
Canada
Facility Name
Stanley Flax Medical Professional Corp.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 3S6
Country
Canada
Facility Name
Univ. Health Network, Princess Margaret Hospital Prostate Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
The Male Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Roger Buckley, MD
City
Willowdale
State/Province
Ontario
ZIP/Postal Code
M2K 2W1
Country
Canada
Facility Name
Urology South Shore Research
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H3
Country
Canada
Facility Name
Les Urologues Associes du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
McGill Urology Associates
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3S 1Z1
Country
Canada
Facility Name
Ultra-Med, Inc.
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
G.R.U.M.
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G9A 3V7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23295793
Citation
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.
Results Reference
derived

Learn more about this trial

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

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