Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Risedronate; Placebo
Intervention description: Daily oral risedronate combined with androgen deprivation; Daily oral placebo combined with androgen deprivation
Intervention MeSH terms: Risedronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.