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

Completed · Phase 3

Conditions studied: Prostate Cancer, Osteoporosis, Fractures

In brief

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.

Key facts

Study ID: NCT00129142
Run by: GTx
People needed: 1200
Starts: 2003-10-01
Expected to finish: 2007-11-01
Last updated by the study team: 2013-11-15

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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%.

You may not qualify if…

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

Where it is running

Coastal Clinical Research — Mobile, Alabama, United States
Arkansas Urology — Little Rock, Arkansas, United States
Advanced Urology Medical Center Clinical Trials — Anaheim, California, United States
Urological Sciences Research Foudation — Culver City, California, United States
Urological Associates of Central CA — Fresno, California, United States
Center of Urologic Research — La Mesa, California, United States
South Orange County Medical Research Center — Laguna Woods, California, United States
Palo Alto VA — Palo Alto, California, 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
West Coast Clinical Research — Tarzana, California, United States
Western Clinical Research, Inc. — Torrance, California, United States
Urology Associates — Denver, Colorado, United States
Western Urological Research — Wheat Ridge, Colorado, United States
Urologic Center — New Haven, Connecticut, United States
Urological Associates of Bridgeport — Trumball, Connecticut, United States
Connecticut Clinical Research — Waterbury, Connecticut, United States
Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
South Florida Medical Research — Aventura, Florida, United States
Urology Consultants Inc. — Clearwater, Florida, United States
Atlantic Urological Associates — Daytona Beach, Florida, United States
Urosearch — Inverness, Florida, United States
Urology Centers of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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