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Prostate CancerPhase 3NCT00129142

Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy

A Phase 3 study testing Toremifene Citrate in people with Prostate Cancer and Osteoporosis, run by GTx at 155 sites in 2 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

Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. Read more about this study

Who is it for?
Ages 50 years and older, men only
Conditions the study is for
Prostate Cancer, Osteoporosis, Fractures
What is being tested?
Toremifene Citrate
How many people
1,200 participants
Where
155 sitesin 2 countries
Study dates
Oct 2003to Nov 2007
Phase
Phase 3
Are there results?
None posted in the registry

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

Who may be able to join

  • To be eligible for participation in this study, subjects must meet all of the following criteria (minor deviations may be discussed with the medical monitor for possible inclusions):
  • Give voluntary, signed informed consent in accordance with institutional policies
  • Be male, aged ≥ 50 years
  • Have histologically documented prostate cancer. Subjects with metastatic prostate cancer may still be considered for the study as long as they are not disqualified by other inclusion/exclusion criteria and there is a reasonable expectation that their medical condition will not interfere with the objectives of the study and that adequate follow-up and compliance with the study protocol can be achieved for the full 24-month duration of the study.
  • Have been on:
  • ADT treatment (either luteinizing hormone-releasing agonist [LHRHa] or orchiectomy) for at least 6 months; Or
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  • Intermittent LHRHa for at least the preceding 12 months is acceptable, but subjects must be maintained on uninterrupted treatment for the duration of this study once they are randomized into the study.
  • Be aged ≥ 70 years or have BMD of lumbar spine or femoral neck at or below the specified thresholds for study entry:
  • Hologic BMD (g/cm2): L1-L4 - 0.926; Femoral neck - 0.717
  • Lunar BMD (g/cm2): L1-L4 - 1.050; Femoral neck - 0.840
  • Serum prostate-specific antigen (PSA) ≤ 4 ng/mL
  • Have a Zubrod performance status ≤ 1
  • Subject weight < 300 lbs (weight limitation of DEXA equipment)
  • Agree to complete a daily diary of medication intake and to provide tablet containers for accurate counts
  • Agree to use an effective method of contraception, if the partner is of childbearing age, while on study
  • 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

  • Subjects with any of the following will not be eligible for enrollment:
  • Taking bisphosphonates, selective estrogen receptor modulators (SERMs), parathyroid hormone (PTH), Forteo® (teriparatide), calcitonin, or oral glucocorticoids within 45 days of randomization
  • Have any disease or condition that would preclude an accurate evaluation of radiographs of the thoracic and lumbar spine (at least eight evaluable vertebrae in the range T4 to L4) [for example, severe scoliosis, or sequelae of orthopedic procedures or other surgery]
  • Have > 4 vertebral fragility fractures
  • Have any history of other carcinomas within the last 5 years (except nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of recurrence which will not be excluded). NOTE: Patients with cancers other than nonmelanoma cutaneous malignancies and superficial bladder cancer with no evidence of tumor recurrence for at least 5 years after definitive treatment will not be excluded from this study.
  • Have Paget's disease of bone
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  • 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 for the full 24-month duration of the study
  • Received treatment with other investigational agents within 30 days prior to randomization
  • Taking finasteride (e.g., Proscar®), dutasteride (e.g., Avodart®), Danocrine® (danazol) or testosterone-like supplements, such as dehydroepiandrosterone (DHEA) [subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study]
  • Taking herbal medicine or dietary supplements for prostate health, such as PC SPES and saw palmetto (also known as Serenoa repens) [subject is eligible if he stops these agents for a total washout of 45 days prior to randomization and agrees not to use these agents for the duration of the study]. Lycopene and selenium are not prohibited and no washout is required.
  • Have a history of thromboembolic disease including deep vein thrombosis or pulmonary embolus
  • Have a history of chronic hepatitis or cirrhosis
  • Have received prior treatment with toremifene

Trial locations and contacts

155 sites in 2 countries.

155 sites in 2 countries

United States136 sites

  • Summa Health Care

    Akron, Ohio, 44304

  • Urology Inst. Of New York

    Albany, New York, 12208

  • William Oberheim

    Albany, New York, 12208

  • Urology Group of New Mexico

    Albuquerque, New Mexico, 87109

  • Adult and Pediatric Urologists of Northern VA

    Alexandria, Virginia, 22304

  • Urologic Associates of Allentown

    Allentown, Pennsylvania, 18103

  • Advanced Urology Medical Center Clinical Trials

    Anaheim, California, 92801

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Anne Arundel Urology P.A.

    Annapolis, Maryland, 21401

  • Asheboro Urology

    Asheboro, North Carolina, 27203

  • Midtown Urology

    Atlanta, Georgia, 30308

  • Georgia Urology

    Atlanta, Georgia, 30342

  • St. Joseph Research Institute

    Atlanta, Georgia, 30342

  • Augusta VAMC

    Augusta, Georgia, 30912

  • Professional Quality Research

    Austin, Texas, 78756

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Urologic Surgery

    Bala-Cynwyd, Pennsylvania, 19004

  • Maryland Prostate Center: University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Odyssey Research

    Bismarck, North Dakota, 58501

  • Coastal Urology Associates

    Brick, New Jersey, 08724

  • University of North Carolina

    Chapel Hill, North Carolina, 27559

  • Wyoming Research Foundation

    Cheyenne, Wyoming, 82001

  • Prairie Medical Associates

    Chicago, Illinois, 60616

  • The Urology Group

    Cincinnati, Ohio, 45212

  • Urology Consultants Inc.

    Clearwater, Florida, 33761

  • Cleveland Clinic Lerner College of Medicine

    Cleveland, Ohio, 44195

  • North Idaho Urology

    Coeur d'Alene, Idaho, 83814

  • Southeastern Medical Research Institute

    Columbus, Georgia, 31904

  • Colombus Urology Research

    Columbus, Ohio, 43214

  • The Corvallis Clinic

    Corvallis, Oregon, 97330

  • Urological Sciences Research Foudation

    Culver City, California, 90232

  • Atlantic Urological Associates

    Daytona Beach, Florida, 32114

  • Urology Associates

    Denver, Colorado, 80210

  • Metropolitan Urologic Services, PC

    Elmont, New York, 11003

  • Urology of Northern Ohio

    Elyria, Ohio, 44035

  • Urological Associates of Central CA

    Fresno, California, 93720

  • Medical and Surgical Specialists

    Galesburg, Illinois, 61401

  • Urological Surgeons of Long Island

    Garden City, New York, 11530

  • The Urology Center

    Greensboro, North Carolina, 27403

  • Urology of Indiana, LLC

    Greenwood, Indiana, 46143

  • MMPC Urology

    Greenwood, Indiana, 49546

  • Radiant Research

    Greer, South Carolina, 29651

  • Urology Center, PA

    Hagerstown, Maryland, 21742

  • Hamilton Urology PA

    Hamilton, New Jersey, 08690

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • Breco Research

    Houston, Texas, 77024

  • Urosearch

    Inverness, Florida, 34452

  • Metropolitan Urology

    Jeffersonville, Indiana, 47130

  • Kansas City Urology, PC

    Kansas City, Missouri, 64131

  • Volunteer Research Group

    Knoxville, Tennessee, 37920

  • Center of Urologic Research

    La Mesa, California, 91942

  • South Orange County Medical Research Center

    Laguna Woods, California, 92653

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Urological Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604

  • Sheldon Freeman

    Las Vegas, Nevada, 89109

  • Lawrenceville Urology Associates

    Lawrenceville, New Jersey, 08648

  • Arkansas Urology

    Little Rock, Arkansas, 72211

  • University of Wisconsin Medical School: Clinical Trials

    Madison, Wisconsin, 53715

  • Urology Enterprises

    Marietta, Georgia, 30060

  • Assoc. Urologic Specialists

    Marlton, New Jersey, 08053

  • Southeast Urology Network

    Memphis, Tennessee, 38119

  • St. Michael's Hospital

    Milwaukee, Wisconsin, 53209

  • Froedtert Memorial Lutheran Hospital Department of Urology

    Milwaukee, Wisconsin, 53226

  • Coastal Clinical Research

    Mobile, Alabama, 36608

  • The Urology Institute

    Monroeville, Pennsylvania, 15146

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Ace Research Specialists

    Nashville, Tennessee, 37203

  • Center for Urological Treatment

    Nashville, Tennessee, 37203

  • Urology Associates

    Nashville, Tennessee, 37209

  • Vanderbilt Medical Center

    Nashville, Tennessee, 37232

  • Urologic Center

    New Haven, Connecticut, 06511

  • LSUHSC/Stanley Scott Cancer Center

    New Orleans, Louisiana, 70112

  • Advance Research Institute

    New Port Richey, Florida, 34652

  • University Urology Associates

    New York, New York, 10016

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Devine Tidewater Urology

    Norfolk, Virginia, 23502

  • Central Florida Urology Group/ UroSearch

    Ocala, Florida, 34474

  • Florida Foundation for Healthcare Research

    Ocala, Florida, 34474

  • Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • CNY Urology

    Oneida, New York, 13421

  • Winter Park Urology Associates

    Orlando, Florida, 32803

  • Palo Alto VA

    Palo Alto, California, 94305

  • Panama City Urology

    Panama City Beach, Florida, 32405

  • Southwest Urology

    Parma, Ohio, 44129

  • Special Care Research

    Peoria, Illinois, 61614

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Ginsberg and Harkaway Urology

    Philadelphia, Pennsylvania, 19141

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • University Urological Research Institute

    Providence, Rhode Island, 02904

  • Wake Urology

    Raleigh, North Carolina, 27607

  • Urologic Surgeons, Ltd.

    Reno, Nevada, 89502

  • Med Atlantic, Inc (Virginia Urology)

    Richmond, Virginia, 23235

  • McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Mayo Clinic Urology Department

    Rochester, Minnesota, 55905

  • Mid Atlantic Clinical Research

    Rockville, Maryland, 28050

  • Harbin Clinic Department of Urology Research

    Rome, Georgia, 30165

  • North Fulton Urology

    Roswell, Georgia, 30076

  • Beaumont Medical

    Royal Oak, Michigan, 48073

  • Park Nicollet Urology

    Saint Louis Park, Minnesota, 55416

  • Salt Lake City Research

    Salt Lake City, Utah, 84124

  • Urology Consultants, PA

    San Antonio, Texas, 78229

  • Urology San Antonio Research, PA

    San Antonio, Texas, 78229

  • San Bernadino Urological Associates

    San Bernadino, California, 92404

  • Urological Physicians of San Diego

    San Diego, California, 92103

  • Veterans Medical Research Foundation

    San Diego, California, 92161

  • Pacific Clinical Research

    Santa Monica, California, 90404

  • St. Joseph's, Candler Health System

    Savannah, Georgia, 31405

  • Seattle VAMC

    Seattle, Washington, 98108

  • Regional Urology LLC

    Shreveport, Louisiana, 71106

  • Deaconess Medical Center

    Spokane, Washington, 99204

  • Oregon Urology Specialists

    Springfield, Oregon, 97477

  • PPS Clinical Research

    St Louis, Missouri, 63141

  • Urologic Research Center

    St Louis, Missouri, 63141

  • Pinellas Urology

    St. Petersburg, Florida, 33710

  • State College Urologic Association

    State College, Pennsylvania, 16801

  • Staten Island Urological Research , PC

    Staten Island, New York, 10304

  • Associated Urologists of CNY

    Syracuse, New York, 13210

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Southeastern Research Group

    Tallahassee, Florida, 32308

  • Tampa Bay Urology

    Tampa, Florida, 33607

  • West Coast Clinical Research

    Tarzana, California, 91356

  • UroSearch

    Tavares, Florida, 32778

  • Scott and White Clinical Hospital

    Temple, Texas, 76508

  • Western Clinical Research, Inc.

    Torrance, California, 90505

  • Urological Associates of Bridgeport

    Trumball, Connecticut, 06611

  • Urologic Specialists of Oklahoma, Inc.

    Tulsa, Oklahoma, 12208

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307

  • Connecticut Clinical Research

    Waterbury, Connecticut, 06708

  • Cleveland Clinic-Florida

    Weston, Florida, 33331

  • Western Urological Research

    Wheat Ridge, Colorado, 80033

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207

  • Center for Urologic Research WNY, LLC

    Williamsville, New York, 14221

  • Urology Healthcare Associates

    Willingboro, New Jersey, 08046

  • Piedmont Medical Research Associates

    Winston-Salem, North Carolina, 27103

  • The Fallon Clinic

    Worcester, Massachusetts, 01605

  • Wayne Glazier

    Worcester, Massachusetts, 01605

Other trials in United States

Mexico19 sites

  • Hospital Civil Viejo "Fray Antonio Alcalde"

    Guadalajara, Jalisco, 44280

  • Centro Medico de Occidente-IMSS

    Guadalajara, Jalisco, 44340

  • Hospital Regional Dr Valentin Gomez Farias, ISSSTE

    Guadalajara, Jalisco

  • American British Cowdray Hospital

    Mexico City, D. F, 01120

  • Centro Medico Dalinde

    Mexico City, D. F, 06760

  • Hospital General de Mexico

    Mexico City, D. F, 06760

  • Hospital Regional "Gabriel Mancera", IMSS

    Mexico City, D.f,

  • Centro Medico Naval

    Mexico City, D.f., 01090

  • Hospital General de Zona No. 1-A

    Mexico City, D.f., 03300

  • Clinica Londres

    Mexico City, D.f., 06760

  • Hospital Central Militar, SDN

    Mexico City, D.f., 11649

  • Hospital Medica Sur

    Mexico City, D.f., 14050

  • Hospital de Oncologia CMN Siglo XXI, IMSS

    Mexico City, D.f.

  • Hospital General de Zona No. 26, Mexico D.F.

    Mexico City, D.f.

  • Hospital General Region 1 de Octubre, ISSSTE

    Mexico City, D.F, 07300

  • Hospital Regional de Especialidades

    Monterrey, N.l., 64320

  • Hospital Universitario

    Monterrey, N.l., 64460

  • Hospital Ignacio Morones Prieto

    San Luis Potosí City, S.l.p., 78240

  • Hospital General de Zona con UMF No. 2 San Luis Potosi

    San Luis Potosí City, S.l.p., 78270

Other trials in Mexico

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy

Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy.

Being tested
Toremifene Citrate
Keywords
Prostate cancer, Bone Loss, Osteoporosis, Fractures, Androgen Deprivation Therapy
Medical subject headings
Prostatic Neoplasms, Osteoporosis, Fractures, Bone, Bone Diseases, Metabolic

What participants receive

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

  • Toremifene CitrateDrug

What is being measured

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

  1. Percentage of subjects at 24 months with at least one new vertebral fracture determined by blinded central review of radiographs of the thoracic and lumbar spine

Secondary outcomes (3)

  1. Percentage of subjects with at least one new or worsening vertebral fracture at 24 months

  2. Percentage of subjects with a clinical fragility fracture at 12 and 24 months

  3. Percent change from baseline in lumbar bone mineral density (BMD) as measured by dual energy x-ray absorptiometry (DEXA) scan at 24 months

Timeline

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

  1. First posted11 Aug 2005 (estimated)
  2. Study startOct 2003
  3. Primary completionNov 2007
  4. Study completionNov 2007

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
Factorial
Masking
Double blind
Enrolment
1,200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129142
Sponsor's protocol ID
G300203
Status last verified
Nov 2013
First submitted
9 Aug 2005
Last updated
15 Nov 2013
Results posted
No

Publications

  • Smith MR, Morton RA, Barnette KG, Sieber PR, Malkowicz SB, Rodriguez D, Hancock ML, Steiner MS. Toremifene to reduce fracture risk in men receiving androgen deprivation therapy for prostate cancer. J Urol. 2013 Jan;189(1 Suppl):S45-50. doi: 10.1016/j.juro.2012.11.016.

    PubMed 23234631

  • Morgans AK, Hancock ML, Barnette KG, Steiner MS, Morton RA, Smith MR. Racial differences in bone mineral density and fractures in men receiving androgen deprivation therapy for prostate cancer. J Urol. 2012 Mar;187(3):889-93. doi: 10.1016/j.juro.2011.10.136. Epub 2012 Jan 15.

    PubMed 22245322

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Toremifene Citrate in people with Prostate Cancer and Osteoporosis, run by GTx at 155 sites in 2 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 21 inclusion and 14 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 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in United States, Mexico. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of subjects at 24 months with at least one new vertebral fracture determined by blinded central review of radiographs of the thoracic and lumbar spine. 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 NCT00129142, which also lists 2 linked publications.

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 15 Nov 2013.

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