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Preneoplastic ConditionsPhase 3NCT00106691

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

A Phase 3 study testing Toremifene 20 mg in people with Preneoplastic Conditions and Prostatic Intraepithelial Neoplasia, run by GTx at 138 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 30 years and older, men only
What is being tested?
Toremifene 20 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,589 participants
Where
138 sitesin 3 countries
Study dates
Jan 2005to Feb 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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%

Who cannot join

  • 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
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  • 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

Trial locations and contacts

138 sites in 3 countries.

138 sites in 3 countries

United States108 sites

  • Summa Health System, Cancer Research Office

    Akron, Ohio, 44304

  • The Urological Institute of Northeastern Research Department

    Albany, New York, 12208

  • Urology Group of New Mexico

    Albuquerque, New Mexico, 87109

  • Urologic Associates of Allentown

    Allentown, Pennsylvania, 18103

  • Anne Arundel Urology

    Annapolis, Maryland, 21401

  • Asheboro Urology Clinic

    Asheboro, North Carolina, 27203

  • Midtown Urology

    Atlanta, Georgia, 30308

  • Georgia Urology

    Atlanta, Georgia, 30342

  • Urology Research Options

    Aurora, Colorado, 80012

  • Professional Quality Research

    Austin, Texas, 78756

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Urologic Surgery, P.C.

    Bala-Cynwyd, Pennsylvania, 19004

  • Maryland Prostate Center: University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Parkhurst Research Organization

    Bethany, Oklahoma, 73008

  • Brigham & Women's Hospital, Division of Urological Surgery

    Boston, Massachusetts, 02115

  • Coastal Urology Associates

    Brick, New Jersey, 08724

  • Boston Clinical Trials

    Brighton, Massachusetts, 02135

  • McKay Urology

    Charlotte, North Carolina, 28204

  • St. Louis Urological Surgeons

    Chesterfield, Missouri, 63017

  • Tri-State Urologic Services/PSC, Inc. d/b/a The Urology Group

    Cincinnati, Ohio, 45212

  • Columbia Urological Associates

    Columbia, South Carolina, 29201

  • Capital Urology

    Columbus, Ohio, 43214

  • Columbus Urology, Inc.

    Columbus, Ohio, 43214

  • Research Across America

    Dallas, Texas, 75234

  • Atlantic Urological Associates

    Daytona Beach, Florida, 32114

  • Urology Associates, P.C.

    Denver, Colorado, 80210

  • The Urology Center of Colorado

    Denver, Colorado, 80211

  • Central Jersey Clinical Research

    Edison, New Jersey, 08837

  • Metropolitan Urologic Services, P.C.

    Elmont, New York, 11003

  • Urology of Northern Ohio

    Elyria, Ohio, 44035

  • Metropolitan Urological Specialists

    Florissant, Missouri, 63031

  • Southwest Florida Urologic Associates

    Fort Myers, Florida, 33907

  • AccuMed Research Associates

    Garden City, New York, 11530

  • Urological Surgeons of Long Island

    Garden City, New York, 11530

  • Urology Center of the South

    Germantown, Tennessee, 38138

  • Michigan Medical, PC Urology

    Grand Rapids, Michigan, 49546

  • Drs. Werner, Murdock, & Francis PA, Urology Associates

    Greenbelt, Maryland, 20770

  • Urology Center, PA

    Hagerstown, Maryland, 21742

  • Hamilton Urology PA

    Hamilton, New Jersey, 08690

  • Connecticut Surgical Group

    Hartford, Connecticut, 06106

  • Medical Affiliated Research Ctr.

    Huntsville, Alabama, 35801

  • Midwest Urology Center

    Independence, Missouri, 64055

  • Urology of Indiana, LLC

    Indianapolis, Indiana, 46254

  • Metropolitan Urology, PSC

    Jeffersonville, Indiana, 47130

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Lake Success Urological Associates

    Lake Success, New York, 11042

  • Urological Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604

  • Sheldon Freeman

    Las Vegas, Nevada, 89109

  • Urology PC

    Lincoln, Nebraska, 68516

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • Urology Associates, PC

    Manhasset, New York, 11030

  • Urology Enterprises

    Marietta, Georgia, 30060

  • Delaware Valley Urology

    Marlton, New Jersey, 08053

  • Southeast Urology Network

    Memphis, Tennessee, 38119

  • University of Tennessee, Dept. of Urology

    Memphis, Tennessee, 38163

  • Southwest Urology

    Middleburg Heights, Ohio, 44130

  • Coastal Clinical Research

    Mobile, Alabama, 36608

  • The Urology Institute

    Monroeville, Pennsylvania, 15146

  • Delaware Valley Urology

    Mount Laurel, New Jersey, 08054

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Urology Associates

    Nashville, Tennessee, 37209

  • Advanced Research Institute

    New Port Richey, Florida, 34652

  • NYU Urology Associates

    New York, New York, 10016

  • University Urology Associates

    New York, New York, 10016

  • Devine-Tidewater Urology

    Norfolk, Virginia, 23502

  • UroSearch

    Ocala, Florida, 34471

  • Central Florida Urology Group/ UroSearch

    Ocala, Florida, 34474

  • Florida Foundation for Healthcare Research

    Ocala, Florida, 34474

  • CNY Urology

    Oneida, New York, 13421

  • Winter Park Urology Associates

    Orlando, Florida, 32803

  • Kansas City Urology Care, P.C.

    Overland Park, Kansas, 66211

  • Panama City Urological Center

    Panama City, Florida, 32405

  • Demaur Clinical Research Center

    Pembroke Pines, Florida, 33028

  • Specialty Care Research

    Peoria, Illinois, 61614

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Hope Research Inst.

    Phoenix, Arizona, 85032

  • DMI Research

    Pinellas Park, Florida, 33782

  • Urology Consultants

    Pinellas Park, Florida, 33782

  • Triangle Urological Group

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh, Department of Urology

    Pittsburgh, Pennsylvania, 15232

  • University Urological Research Institute

    Providence, Rhode Island, 02904

  • Wake Urology Associates

    Raleigh, North Carolina, 27607

  • Urologic Surgeons, Ltd.

    Reno, Nevada, 89502

  • Med Atlantic, Inc (Virginia Urology)

    Richmond, Virginia, 23235

  • Mid Atlantic Clinical Research

    Rockville, Maryland, 28050

  • North Fulton Urology

    Roswell, Georgia, 30076

  • Mich. Inst. of Urology

    Saint Clair Shores, Michigan, 48081

  • Advanced Clinical Research

    Salt Lake City, Utah, 84102

  • Salt Lake Research

    Salt Lake City, Utah, 84107

  • Urology San Antonio Research, PA

    San Antonio, Texas, 78229

  • San Bernardino Urological Associates Medical Group

    San Bernardino, California, 92404

  • Florida Urology Specialists

    Sarasota, Florida, 34237

  • Adult & Pediatric Urology

    Sartell, Minnesota, 56377

  • St. Joseph's, Candler Health System

    Savannah, Georgia, 31405

  • Seattle Urological Associates

    Seattle, Washington, 98104

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • Oregon Urology Specialists

    Springfield, Oregon, 97477

  • Washington University Urologic Research Ctr.

    St Louis, Missouri, 63110

  • State College Urologic Associates, Inc.

    State College, Pennsylvania, 16801

  • Staten Island Urological Research

    Staten Island, New York, 10304

  • Urologic Northwest Surgeons

    Tacoma, Washington, 98405

  • Urology Services Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Western Clinical Research, Inc.

    Torrance, California, 90505

  • Chesapeake Urology Research Assoc.

    Towson, Maryland, 21204

  • Urological Associates of Bridgeport

    Trumbull, Connecticut, 06611

  • Urologic Specialists of Oklahoma Research Department

    Tulsa, Oklahoma, 74104

  • Connecticut Clinical Research

    Waterbury, Connecticut, 06708

Other trials in United States

Canada24 sites

  • Male/Female Health and Research Centre

    Barrie, Ontario, L4M 7G1

  • Burlington Urology

    Burlington, Ontario, L7N 3V2

  • Prostate Cancer Inst.

    Calgary, Alberta

  • Alberta Urology Inst.. Research Center

    Edmonton, Alberta, T5H4B9

  • Allan B. Patrick, M.D. Professional corporation

    Fredericton, New Brunswick, E3B5B8

  • Urology South Shore Research

    Greenfield Park, Quebec, J4V 2H3

  • Queen Elizabeth Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Southern Interior Medical Research Inc.

    Kelowna, British Columbia, V1H 2H4

  • Centre for Advanced Urological Research

    Kingston, Ontario, K7L 3J7

  • Urology Assoc./Urologic Medical Research

    Kitchener, Ontario, N2N 2B9

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Les Urologues Associes du CHUM

    Montreal, Quebec, H2X 1N8

  • McGill Urology Associates

    Montreal, Quebec, H3S 1Z1

  • Mor Urology

    Newmarket, Ontario, L3X 1W1

  • The Fe/Male Health Centres

    Oakville, Ontario, L6H 3P1

  • Urotec

    Oshawa, Ontario, L1H 7K4

  • Ultra-Med, Inc.

    Pointe-Claire, Quebec, H9R 4S3

  • The Health Institute for Men

    Toronto, Ontario, M1P 2T7

  • Stanley Flax Medical Professional Corp.

    Toronto, Ontario, M3B 3S6

  • Univ. Health Network, Princess Margaret Hospital Prostate Centre

    Toronto, Ontario, M5G 2M9

  • The Male Health Centre

    Toronto, Ontario, M6A 3B5

  • G.R.U.M.

    Trois-Rivières, Quebec, G9A 3V7

  • Dr. G. Steinhoff Clinical Research

    Victoria, British Columbia, V8V3N1

  • Roger Buckley, MD

    Willowdale, Ontario, M2K 2W1

Other trials in Canada

Argentina6 sites

  • Centro Urologico Buenos Aires

    Buenos Aires

  • Hospital Italiano de Buenos Aires

    Buenos Aires

  • Hospital Pirovano

    Buenos Aires

  • Policlinico Bancario de Buenos Aires

    Buenos Aires

  • Sanatorio Municipal

    Buenos Aires

  • Servicio de Urologia

    Buenos Aires

Other trials in Argentina

About this study

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)

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).

Read the 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.

Being tested
Toremifene 20 mg, Placebo
Keywords
neoplasia, chemoprevention, cancer, premalignant, precancerous, Chemoprophylaxis, Intraepithelial Prostatic Neoplasia, Neoplasia, Prostatic Intraepithelial
Medical subject headings
Precancerous Conditions, Prostatic Intraepithelial Neoplasia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Toremifene 20 mgDrug

    The subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).

  • PlaceboDrug

    The subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days.

Study groups in NCT00106691
Study groupRoleWhat they receive
20 mg Toremifene CitrateExperimentalThe subject takes one dose by mouth of the 20mg Toremifine Citrate tablet once a day for the length of the trial (360 days).
Receives: Drug: Toremifene 20 mg
PlaceboExperimentalThe subject takes a placebo tablet identical in appearance to the toremifene 20mg tablet, administered by mouth daily for 360 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: The outcome measurement time is up to 36 months

  2. Occurrence of a Positive Cancer Biopsy

    To measure the occurrence of a positive cancer biopsy

    Measured: Up to 36 months

Secondary outcomes (6)

  1. The Effect of Toremifene on Lipid Levels

    Measure lipid levels including total cholesterol, LDL, HDL and Triglycerides % change from baseline

    Measured: Up to 36 months

  2. The Effect of Toremifene on Hormone Levels

    % Change from baseline hormone levels, including total testosterone, free testosterone, dihydrotestosterone (DHT) and estradiol

    Measured: Up to 36 months

  3. 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

    Measured: Up to 36 months

  4. 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

    Measured: 36 months

  5. 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.

    Measured: Up to 36 months

  6. 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

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00106691
Sponsor's protocol ID
G300104
Status last verified
May 2023
First submitted
29 Mar 2005
Last updated
12 Jun 2023
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23295793

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Toremifene 20 mg in people with Preneoplastic Conditions and Prostatic Intraepithelial Neoplasia, run by GTx at 138 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Canada, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Toremifene in the Prevention of Prostate Cancer in Men With High Grade Prostatic Intraepithelial Neoplasia (PIN) (time frame: The outcome measurement time is up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00106691, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.

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