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

Clinical trial: Radiation Therapy in Treating Patients With Prostate Cancer

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer.
  PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer.

Detailed description: OBJECTIVES:
  -  Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy.
  -  Compare the incidence of biochemical failure (prostate-specific antigen (PSA) greater than 2 ng/mL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50%), development of metastases, and survival in patients treated with these regimens.
  -  Compare the acute and late radiation-induced side effects of these regimens in this patient population.
  -  Compare aspects of quality of life, health economics, models of normal tissue, and tumor control in patients treated with these regimens.
  OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen, T stage, and Gleason score. Patients are randomized to one of two treatment arms.
  All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy.
  -  Arm I: Patients undergo standard conformal radiotherapy for 6.5 weeks.
  -  Arm II: Patients undergo high-dose conformal radiotherapy for 7.5 weeks. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually thereafter.
  Patients are followed every 6 months for 2 years and then annually thereafter.
  PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed prostate cancer
  -  T1b-T3a, N0, M0 (stage II or III)
  -  Prostate-specific antigen at least 50 ng/mL
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  WHO 0-1
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  WBC greater than 4,000/mm^3
  -  Platelet count greater than 100,000/mm^3
  -  Hemoglobin greater than 11 g/dL
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No significant past medical history that would preclude radical radiotherapy
  -  No condition that would preclude standard radiotherapy
  -  No hip prosthesis
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  No prior androgen deprivation therapy
  Radiotherapy:
  -  No prior pelvic radiotherapy
  Surgery:
  -  No prior radical prostatectomy

Relevance to patient case: not relevant