Patient case: 81-year-old male with Prostate cancer. Genetic variant: PTEN Inactivating. Other conditions: Hypertension, Depression.

Clinical trial: Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy

Summary: RATIONALE: Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy. It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer.
  PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy.

Detailed description: OBJECTIVES:
  Primary
  -  Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus vitamin D and calcium supplement vs standard therapy with vitamin D and calcium supplement in the prevention of osteoporosis and associated bone fractures in patients with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing radiotherapy and luteinizing hormone-releasing hormone (LHRH) agonist therapy.
  Secondary
  -  Evaluate the potential benefit of these regimens on quality of life in these patients.
  -  Evaluate the potential benefit in bone mineral density over a period of 3 years for patients treated with these regimens.
  OUTLINE: This is randomized multicenter study. Patients are stratified according to T score of the hip by dual x-ray absorptiometry (DXA) scan (< -1.0 but > -2.5 vs ≥ - 1.0) and planned duration of luteinizing hormone-releasing hormone (LHRH) agonist therapy (1-2½ years vs > 2½ years). Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Parents receive zoledronate IV over 15 minutes once every 6 months. Patients also receive oral calcium and oral cholecalciferol (vitamin D) once daily. Treatment continues for 3 years in the absence of bone fractures, disease progression, or unacceptable toxicity.
  -  Arm II: Patients receive oral calcium and oral vitamin D once daily. Treatment continues for 3 years in the absence of bone fractures, disease progression, or unacceptable toxicity.
  All patients also undergo concurrent radiotherapy (external beam, brachytherapy, or both) and LHRH agonist (e.g., leuprolide acetate, goserelin, buserelin, or triptorelin) therapy.
  Quality of life is assessed at baseline and every 6 months during treatment.
  PROJECTED ACCRUAL: A total of 1,272 patients will be accrued for this study.

Eligibility: 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 Characteristics
  -  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

Relevance to patient case: not relevant