Prostate Cancer Clinical Trial
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
Verified date | November 2013 |
Source | GTx |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
GTx |
United States, Mexico,
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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