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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00129142
Other study ID # G300203
Secondary ID
Status Completed
Phase Phase 3
First received August 9, 2005
Last updated November 13, 2013
Start date October 2003
Est. completion date November 2007

Study information

Verified date November 2013
Source GTx
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility Inclusion Criteria:

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

- 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%.

Exclusion Criteria:

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

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
Toremifene Citrate


Locations

Country Name City State
Mexico Centro Medico de Occidente-IMSS Guadalajara Jal
Mexico Hospital Civil Viejo "Fray Antonio Alcalde" Guadalajara Jal
Mexico Hospital Regional Dr Valentin Gomez Farias, ISSSTE Guadalajara Jal
Mexico American British Cowdray Hospital Mexico City D. F
Mexico Centro Medico Dalinde Mexico City D. F
Mexico Centro Medico Naval Mexico City D.f.
Mexico Clinica Londres Mexico City D.f.
Mexico Hospital Central Militar, SDN Mexico City D.f.
Mexico Hospital de Oncologia CMN Siglo XXI, IMSS Mexico City D.f.
Mexico Hospital General de Mexico Mexico City D. F
Mexico Hospital General de Zona No. 1-A Mexico City D.f.
Mexico Hospital General de Zona No. 26, Mexico D.F. Mexico City D.f.
Mexico Hospital General Region 1 de Octubre, ISSSTE Mexico City D.F
Mexico Hospital Medica Sur Mexico City D.f.
Mexico Hospital Regional "Gabriel Mancera", IMSS Mexico City D.f,
Mexico Hospital Regional de Especialidades Monterrey N.l.
Mexico Hospital Universitario Monterrey N.l.
Mexico Hospital General de Zona con UMF No. 2 San Luis Potosi San Luis Potosi S.l.p.
Mexico Hospital Ignacio Morones Prieto San Luis Potosi S.l.p.
United States Summa Health Care Akron Ohio
United States Urology Inst. Of New York Albany New York
United States William Oberheim Albany New York
United States Urology Group of New Mexico Albuquerque New Mexico
United States Adult and Pediatric Urologists of Northern VA Alexandria Virginia
United States Urologic Associates of Allentown Allentown Pennsylvania
United States Advanced Urology Medical Center Clinical Trials Anaheim California
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Anne Arundel Urology P.A. Annapolis Maryland
United States Asheboro Urology Asheboro North Carolina
United States Georgia Urology Atlanta Georgia
United States Midtown Urology Atlanta Georgia
United States St. Joseph Research Institute Atlanta Georgia
United States Augusta VAMC Augusta Georgia
United States Professional Quality Research Austin Texas
United States South Florida Medical Research Aventura Florida
United States Urologic Surgery Bala Cynwyd Pennsylvania
United States Maryland Prostate Center: University of Maryland Medical Center Baltimore Maryland
United States Odyssey Research Bismarck North Dakota
United States Coastal Urology Associates Brick New Jersey
United States University of North Carolina Chapel Hill North Carolina
United States Wyoming Research Foundation Cheyenne Wyoming
United States Prairie Medical Associates Chicago Illinois
United States The Urology Group Cincinnati Ohio
United States Urology Consultants Inc. Clearwater Florida
United States Cleveland Clinic Lerner College of Medicine Cleveland Ohio
United States North Idaho Urology Coeur d'Alene Idaho
United States Colombus Urology Research Columbus Ohio
United States Southeastern Medical Research Institute Columbus Georgia
United States The Corvallis Clinic Corvallis Oregon
United States Urological Sciences Research Foudation Culver City California
United States Atlantic Urological Associates Daytona Beach Florida
United States Urology Associates Denver Colorado
United States Metropolitan Urologic Services, PC Elmont New York
United States Urology of Northern Ohio Elyria Ohio
United States Urological Associates of Central CA Fresno California
United States Medical and Surgical Specialists Galesburg Illinois
United States Urological Surgeons of Long Island Garden City New York
United States The Urology Center Greensboro North Carolina
United States MMPC Urology Greenwood Indiana
United States Urology of Indiana, LLC Greenwood Indiana
United States Radiant Research Greer South Carolina
United States Urology Center, PA Hagerstown Maryland
United States Hamilton Urology PA Hamilton New Jersey
United States Urology Centers of Alabama Homewood Alabama
United States Breco Research Houston Texas
United States Urosearch Inverness Florida
United States Metropolitan Urology Jeffersonville Indiana
United States Kansas City Urology, PC Kansas Missouri
United States Volunteer Research Group Knoxville Tennessee
United States Center of Urologic Research La Mesa California
United States South Orange County Medical Research Center Laguna Woods California
United States Lakeland Regional Medical Center Lakeland Florida
United States Urological Associates of Lancaster, Ltd. Lancaster Pennsylvania
United States Sheldon Freeman Las Vegas Nevada
United States Lawrenceville Urology Associates Lawrenceville New Jersey
United States Arkansas Urology Little Rock Arkansas
United States University of Wisconsin Medical School: Clinical Trials Madison Wisconsin
United States Urology Enterprises Marietta Georgia
United States Assoc. Urologic Specialists Marlton New Jersey
United States Southeast Urology Network Memphis Tennessee
United States Froedtert Memorial Lutheran Hospital Department of Urology Milwaukee Wisconsin
United States St. Michael's Hospital Milwaukee Wisconsin
United States Coastal Clinical Research Mobile Alabama
United States The Urology Institute Monroeville Pennsylvania
United States Carolina Urologic Research Center Myrtle Beach South Carolina
United States Ace Research Specialists Nashville Tennessee
United States Center for Urological Treatment Nashville Tennessee
United States Urology Associates Nashville Tennessee
United States Vanderbilt Medical Center Nashville Tennessee
United States Urologic Center New Haven Connecticut
United States LSUHSC/Stanley Scott Cancer Center New Orleans Louisiana
United States Advance Research Institute New Port Richey Florida
United States Mount Sinai School of Medicine New York New York
United States University Urology Associates New York New York
United States Devine Tidewater Urology Norfolk Virginia
United States Central Florida Urology Group/ UroSearch Ocala Florida
United States Florida Foundation for Healthcare Research Ocala Florida
United States Oklahoma University Medical Center Oklahoma City Oklahoma
United States CNY Urology Oneida New York
United States Winter Park Urology Associates Orlando Florida
United States Palo Alto VA Palo Alto California
United States Panama City Urology Panama City Beach Florida
United States Southwest Urology Parma Ohio
United States Special Care Research Peoria Illinois
United States Ginsberg and Harkaway Urology Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania
United States University of Pittsburgh Pittsburgh Pennsylvania
United States University Urological Research Institute Providence Rhode Island
United States Wake Urology Raleigh North Carolina
United States Urologic Surgeons, Ltd. Reno Nevada
United States McGuire VA Medical Center Richmond Virginia
United States Med Atlantic, Inc (Virginia Urology) Richmond Virginia
United States Mayo Clinic Urology Department Rochester Minnesota
United States Mid Atlantic Clinical Research Rockville Maryland
United States Harbin Clinic Department of Urology Research Rome Georgia
United States North Fulton Urology Roswell Georgia
United States Beaumont Medical Royal Oak Michigan
United States Salt Lake City Research Salt Lake City Utah
United States Urology Consultants, PA San Antonio Texas
United States Urology San Antonio Research, PA San Antonio Texas
United States San Bernadino Urological Associates San Bernadino California
United States Urological Physicians of San Diego San Diego California
United States Veterans Medical Research Foundation San Diego California
United States Pacific Clinical Research Santa Monica California
United States St. Joseph's, Candler Health System Savannah Georgia
United States Seattle VAMC Seattle Washington
United States Regional Urology LLC Shreveport Louisiana
United States Deaconess Medical Center Spokane Washington
United States Oregon Urology Specialists Springfield Oregon
United States PPS Clinical Research St Louis Missouri
United States Urologic Research Center St. Louis Missouri
United States Park Nicollet Urology St. Louis Park Minnesota
United States Pinellas Urology St. Petersburg Florida
United States State College Urologic Association State College Pennsylvania
United States Staten Island Urological Research , PC Staten Island New York
United States Associated Urologists of CNY Syracuse New York
United States Madigan Army Medical Center Tacoma Washington
United States Southeastern Research Group Tallahassee Florida
United States Tampa Bay Urology Tampa Florida
United States West Coast Clinical Research Tarzana California
United States UroSearch Tavares Florida
United States Scott and White Clinical Hospital Temple Texas
United States Western Clinical Research, Inc. Torrance California
United States Urological Associates of Bridgeport Trumball Connecticut
United States Urologic Specialists of Oklahoma, Inc. Tulsa Oklahoma
United States Walter Reed Army Medical Center Washington District of Columbia
United States Connecticut Clinical Research Waterbury Connecticut
United States Cleveland Clinic-Florida Weston Florida
United States Western Urological Research Wheat Ridge Colorado
United States Heartland Research Associates, LLC Wichita Kansas
United States Center for Urologic Research WNY, LLC Williamsville New York
United States Urology Healthcare Associates Willingboro New Jersey
United States Piedmont Medical Research Associates Winston-Salem North Carolina
United States The Fallon Clinic Worcester Massachusetts
United States Wayne Glazier Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
GTx

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of subjects with at least one new or worsening vertebral fracture at 24 months
Secondary Percentage of subjects with a clinical fragility fracture at 12 and 24 months
Secondary Percent change from baseline in lumbar bone mineral density (BMD) as measured by dual energy x-ray absorptiometry (DEXA) scan at 24 months
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