Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy
- Conditions
- Prostate CancerOsteoporosisFractures
- Registration Number
- NCT00129142
- Lead Sponsor
- GTx
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1200
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%.
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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percentage of subjects with at least one new or worsening vertebral fracture at 24 months Percentage of subjects with a clinical fragility fracture at 12 and 24 months Percent change from baseline in lumbar bone mineral density (BMD) as measured by dual energy x-ray absorptiometry (DEXA) scan at 24 months
Trial Locations
- Locations (154)
Urologic Associates of Allentown
🇺🇸Allentown, Pennsylvania, United States
The Urology Center
🇺🇸Greensboro, North Carolina, United States
Wake Urology
🇺🇸Raleigh, North Carolina, United States
Maryland Prostate Center: University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Georgia Urology
🇺🇸Atlanta, Georgia, United States
St. Joseph Research Institute
🇺🇸Atlanta, Georgia, United States
Colombus Urology Research
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Lerner College of Medicine
🇺🇸Cleveland, Ohio, United States
Breco Research
🇺🇸Houston, Texas, United States
Veterans Medical Research Foundation
🇺🇸San Diego, California, United States
Sheldon Freeman
🇺🇸Las Vegas, Nevada, United States
Urology Consultants, PA
🇺🇸San Antonio, Texas, United States
Urology San Antonio Research, PA
🇺🇸San Antonio, Texas, United States
Hospital de Oncologia CMN Siglo XXI, IMSS
🇲🇽Mexico City, D.f., Mexico
Hospital Regional Dr Valentin Gomez Farias, ISSSTE
🇲🇽Guadalajara, Jal, Mexico
Centro Medico de Occidente-IMSS
🇲🇽Guadalajara, Jal, Mexico
Hospital Regional "Gabriel Mancera", IMSS
🇲🇽Mexico City, D.f,, Mexico
Centro Medico Naval
🇲🇽Mexico City, D.f., Mexico
American British Cowdray Hospital
🇲🇽Mexico City, D. F, Mexico
Clinica Londres
🇲🇽Mexico City, D.f., Mexico
Hospital Regional de Especialidades
🇲🇽Monterrey, N.l., Mexico
Urology Associates
🇺🇸Nashville, Tennessee, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Ace Research Specialists
🇺🇸Nashville, Tennessee, United States
Center for Urological Treatment
🇺🇸Nashville, Tennessee, United States
Salt Lake City Research
🇺🇸Salt Lake City, Utah, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Urological Sciences Research Foudation
🇺🇸Culver City, California, United States
Coastal Clinical Research
🇺🇸Mobile, Alabama, United States
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
Urological Associates of Central CA
🇺🇸Fresno, California, United States
South Orange County Medical Research Center
🇺🇸Laguna Woods, California, United States
Palo Alto VA
🇺🇸Palo Alto, California, United States
Urological Physicians of San Diego
🇺🇸San Diego, California, United States
San Bernadino Urological Associates
🇺🇸San Bernadino, California, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Midtown Urology
🇺🇸Atlanta, Georgia, United States
Medical and Surgical Specialists
🇺🇸Galesburg, Illinois, United States
The Fallon Clinic
🇺🇸Worcester, Massachusetts, United States
Beaumont Medical
🇺🇸Royal Oak, Michigan, United States
Staten Island Urological Research , PC
🇺🇸Staten Island, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Seattle VAMC
🇺🇸Seattle, Washington, United States
Wyoming Research Foundation
🇺🇸Cheyenne, Wyoming, United States
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
Urology Inst. Of New York
🇺🇸Albany, New York, United States
Urological Surgeons of Long Island
🇺🇸Garden City, New York, United States
Associated Urologists of CNY
🇺🇸Syracuse, New York, United States
Mayo Clinic Urology Department
🇺🇸Rochester, Minnesota, United States
St. Michael's Hospital
🇺🇸Milwaukee, Wisconsin, United States
Froedtert Memorial Lutheran Hospital Department of Urology
🇺🇸Milwaukee, Wisconsin, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Ginsberg and Harkaway Urology
🇺🇸Philadelphia, Pennsylvania, United States
Piedmont Medical Research Associates
🇺🇸Winston-Salem, North Carolina, United States
Tampa Bay Urology
🇺🇸Tampa, Florida, United States
Advanced Urology Medical Center Clinical Trials
🇺🇸Anaheim, California, United States
Center of Urologic Research
🇺🇸La Mesa, California, United States
Pacific Clinical Research
🇺🇸Santa Monica, California, United States
Western Clinical Research, Inc.
🇺🇸Torrance, California, United States
West Coast Clinical Research
🇺🇸Tarzana, California, United States
Western Urological Research
🇺🇸Wheat Ridge, Colorado, United States
Urological Associates of Bridgeport
🇺🇸Trumball, Connecticut, United States
Urologic Center
🇺🇸New Haven, Connecticut, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Connecticut Clinical Research
🇺🇸Waterbury, Connecticut, United States
Urology Consultants Inc.
🇺🇸Clearwater, Florida, United States
Atlantic Urological Associates
🇺🇸Daytona Beach, Florida, United States
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Florida Foundation for Healthcare Research
🇺🇸Ocala, Florida, United States
Urosearch
🇺🇸Inverness, Florida, United States
Advance Research Institute
🇺🇸New Port Richey, Florida, United States
Central Florida Urology Group/ UroSearch
🇺🇸Ocala, Florida, United States
Panama City Urology
🇺🇸Panama City Beach, Florida, United States
Pinellas Urology
🇺🇸St. Petersburg, Florida, United States
Southeastern Research Group
🇺🇸Tallahassee, Florida, United States
Winter Park Urology Associates
🇺🇸Orlando, Florida, United States
UroSearch
🇺🇸Tavares, Florida, United States
Cleveland Clinic-Florida
🇺🇸Weston, Florida, United States
Augusta VAMC
🇺🇸Augusta, Georgia, United States
Southeastern Medical Research Institute
🇺🇸Columbus, Georgia, United States
Urology Enterprises
🇺🇸Marietta, Georgia, United States
Harbin Clinic Department of Urology Research
🇺🇸Rome, Georgia, United States
North Fulton Urology
🇺🇸Roswell, Georgia, United States
St. Joseph's, Candler Health System
🇺🇸Savannah, Georgia, United States
Prairie Medical Associates
🇺🇸Chicago, Illinois, United States
North Idaho Urology
🇺🇸Coeur d'Alene, Idaho, United States
Special Care Research
🇺🇸Peoria, Illinois, United States
MMPC Urology
🇺🇸Greenwood, Indiana, United States
Urology of Indiana, LLC
🇺🇸Greenwood, Indiana, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Metropolitan Urology
🇺🇸Jeffersonville, Indiana, United States
LSUHSC/Stanley Scott Cancer Center
🇺🇸New Orleans, Louisiana, United States
Regional Urology LLC
🇺🇸Shreveport, Louisiana, United States
Anne Arundel Urology P.A.
🇺🇸Annapolis, Maryland, United States
Urology Center, PA
🇺🇸Hagerstown, Maryland, United States
Mid Atlantic Clinical Research
🇺🇸Rockville, Maryland, United States
Wayne Glazier
🇺🇸Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Kansas City Urology, PC
🇺🇸Kansas, Missouri, United States
Park Nicollet Urology
🇺🇸St. Louis Park, Minnesota, United States
Urologic Surgeons, Ltd.
🇺🇸Reno, Nevada, United States
PPS Clinical Research
🇺🇸St Louis, Missouri, United States
Urologic Research Center
🇺🇸St. Louis, Missouri, United States
Coastal Urology Associates
🇺🇸Brick, New Jersey, United States
Hamilton Urology PA
🇺🇸Hamilton, New Jersey, United States
Assoc. Urologic Specialists
🇺🇸Marlton, New Jersey, United States
Lawrenceville Urology Associates
🇺🇸Lawrenceville, New Jersey, United States
Urology Healthcare Associates
🇺🇸Willingboro, New Jersey, United States
William Oberheim
🇺🇸Albany, New York, United States
Urology Group of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Metropolitan Urologic Services, PC
🇺🇸Elmont, New York, United States
University Urology Associates
🇺🇸New York, New York, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
CNY Urology
🇺🇸Oneida, New York, United States
Center for Urologic Research WNY, LLC
🇺🇸Williamsville, New York, United States
Asheboro Urology
🇺🇸Asheboro, North Carolina, United States
Odyssey Research
🇺🇸Bismarck, North Dakota, United States
Summa Health Care
🇺🇸Akron, Ohio, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Urology of Northern Ohio
🇺🇸Elyria, Ohio, United States
Southwest Urology
🇺🇸Parma, Ohio, United States
Urologic Specialists of Oklahoma, Inc.
🇺🇸Tulsa, Oklahoma, United States
Oregon Urology Specialists
🇺🇸Springfield, Oregon, United States
The Corvallis Clinic
🇺🇸Corvallis, Oregon, United States
Urologic Surgery
🇺🇸Bala Cynwyd, Pennsylvania, United States
Urological Associates of Lancaster, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
The Urology Institute
🇺🇸Monroeville, Pennsylvania, United States
State College Urologic Association
🇺🇸State College, Pennsylvania, United States
University Urological Research Institute
🇺🇸Providence, Rhode Island, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
Volunteer Research Group
🇺🇸Knoxville, Tennessee, United States
Southeast Urology Network
🇺🇸Memphis, Tennessee, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
Professional Quality Research
🇺🇸Austin, Texas, United States
Scott and White Clinical Hospital
🇺🇸Temple, Texas, United States
University of Wisconsin Medical School: Clinical Trials
🇺🇸Madison, Wisconsin, United States
Med Atlantic, Inc (Virginia Urology)
🇺🇸Richmond, Virginia, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Deaconess Medical Center
🇺🇸Spokane, Washington, United States
Hospital General de Mexico
🇲🇽Mexico City, D. F, Mexico
Centro Medico Dalinde
🇲🇽Mexico City, D. F, Mexico
Hospital General de Zona No. 1-A
🇲🇽Mexico City, D.f., Mexico
Hospital Central Militar, SDN
🇲🇽Mexico City, D.f., Mexico
Hospital Medica Sur
🇲🇽Mexico City, D.f., Mexico
Hospital Universitario
🇲🇽Monterrey, N.l., Mexico
Hospital Civil Viejo "Fray Antonio Alcalde"
🇲🇽Guadalajara, Jal, Mexico
Hospital Ignacio Morones Prieto
🇲🇽San Luis Potosi, S.l.p., Mexico
Hospital General de Zona con UMF No. 2 San Luis Potosi
🇲🇽San Luis Potosi, S.l.p., Mexico
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Devine Tidewater Urology
🇺🇸Norfolk, Virginia, United States
Adult and Pediatric Urologists of Northern VA
🇺🇸Alexandria, Virginia, United States
Radiant Research
🇺🇸Greer, South Carolina, United States