A Phase III Randomized Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Diagnosed within the past 12 months

- Any 1 of the following clinical stages:

- Clinical stage T3, any N, M0 with any Gleason score and any prostate-specific
antigen (PSA)

- Any T, any N, M0 with one of the following:

- Gleason score ≥ 8 and any PSA

- Gleason score 7 and PSA ≥ 15 ng/mL

- Gleason score < 7 and PSA ≥ 20 ng/mL

- Baseline T score > -2.5 in both the L spine and the total hip by dual x-ray
absorptiometry (DXA) scan

- Planning to receive luteinizing hormone-releasing hormone (LHRH) agonist therapy

- If patient is receiving LHRH therapy before study entry, therapy must have begun
≤ 6 months prior to study entry

- Scheduled to receive a LHRH agonist for ≥ 1 year

- Planning to undergo radiotherapy (i.e., external-beam, brachytherapy, or both)

- No distant metastases

- Must have negative bone scan for metastatic disease

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- Creatinine clearance > 30 mL/min

- Calcium 8.4-10.6 mg/dL

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment

- No history of Paget's disease

- No uncontrolled thyroid or parathyroid dysfunction

- No known hypersensitivity to zoledronate or other bisphosphonates

- No infection of the teeth or jawbone

- No dental or fixture trauma

- No current or prior diagnosis of osteonecrosis of the jaw

- No exposed bone in the mouth

- No slow healing after dental procedures

- No other active dental problems

- No other diseases that influence bone metabolism

- No other malignancy within the past 3 years except nonmelanomatous skin cancer or
carcinoma in situ of the breast or oral cavity

PRIOR CONCURRENT THERAPY:

- See Disease Characterisitics

- More than 6 weeks since prior dental or jaw surgery (e.g., extraction, implants)

- No prior bisphosphonate therapy

- No prior pelvic radiation

- No prior systemic radiotherapeutic agents, such as strontium chloride Sr 89 or
samarium Sm 153 lexidronam pentasodium

- No concurrent systemic chemotherapy

- No concurrent steroids

- No concurrent growth hormones

- No concurrent calcitonin

- No concurrent dental or jaw surgery