Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Metastatic Prostate Cancer

In brief

Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.

Key facts

Study ID

NCT00216060

Run by

Christopher Sweeney, MBBS

People needed

63

Starts

2003-10-01

Expected to finish

2008-03-01

Last updated by the study team

2016-05-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the prostate with metastatic bone disease (by CT, MRI or bone scan) with plans to start or be < 30 days from beginning androgen deprivation therapy. Patients with lymph node or visceral metastases only are not eligible
• Patients may receive palliative radiation therapy at the investigators discretion during the first 4 weeks of beginning protocol therapy.

You may not qualify if…

• No neuroendocrine, small cell or transitional cell cancer of the prostate No abnormal bone metabolism (i.e., Paget's disease, untreated hyperthyroidism, untreated hyperprolactinemia, untreated Cushing's disease).
• No use of calcitonin within 14 days before being registered for protocol therapy or any previous use of bisphosphonates.
• No major surgery within 4 weeks of registration to protocol therapy.
• No adjuvant chemotherapy within 6 months of registration to protocol therapy.
• No previous chemotherapy for metastatic disease.
• No hormonal therapy in the adjuvant setting within 12 months of registration to protocol therapy; previous hormonal therapy must not have exceeded 6 months.
• No prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin.
• No history of allergy or drug reactions to bisphosphonates.

Where it is running

• Center for Urological Research — La Mesa, California, United States
• San Bernadino Urological Associates — San Bernardino, California, United States
• Grove Hill Medical Center Urology — New Britain, Connecticut, United States
• Innovative Surgical Resources — Tampa, Florida, United States
• Medical & Surgical Specialists, LLC — Galesburg, Illinois, United States
• Peoria Urological Associates — Peoria, Illinois, United States
• Oncology Hematology Associates of SW Indiana — Evansville, Indiana, United States
• Center for Cancer Care at Goshen Health System — Goshen, Indiana, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Quality Cancer Center (MCGOP) — Indianapolis, Indiana, United States
• Urology of Indiana, LLC — Indianapolis, Indiana, United States
• Urology Associates — Muncie, Indiana, United States
• Northern Indiana Cancer Research Consortium — South Bend, Indiana, United States
• Urologic Surgery Associates — Baltimore, Maryland, United States
• Drs. Werner, Murdock and Francis PA Urology Associates — Greenbelt, Maryland, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Kansas City Urology Care — Kansas City, Missouri, United States
• Siteman Cancer Center — St Louis, Missouri, United States
• Nevada Urology — Reno, Nevada, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Lawrenceville Urology — Trenton, New Jersey, United States
• Accumed Research Associates — Garden City, New York, United States
• Staten Island Urological Research, P.C. — Staten Island, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Oregon Urology Specialists — Springfield, Oregon, United States

Full record on ClinicalTrials.gov

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