Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation
      therapy in different ways may cause less damage to normal tissue and may improve quality of
      life and help patients live more comfortably. Androgens can stimulate the growth of prostate
      cancer cells. Drugs such as goserelin and bicalutamide may fight cancer by stopping the
      production of androgens. It is not yet known whether radiation therapy is more effective with
      or without goserelin and bicalutamide in treating prostate cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of high-dose radiation
      therapy with or without bicalutamide and goserelin in treating patients who have prostate
      cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the quality of life of patients with high-grade intermediate-risk or
           unfavorable-risk adenocarcinoma of the prostate when treated with high-dose
           intensity-modulated radiotherapy alone versus with androgen deprivation comprising
           bicalutamide and goserelin.

        -  Compare the prostate-specific antigen relapse-free, distant metastases-free, and overall
           survival of patients treated with these regimens.

        -  Compare the toxicity of these regimens in these patients.

        -  Compare the local control in patients treated with these regimens, based on
           post-treatment sextant biopsies performed 4 years after study completion.

      OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific
      antigen level, Gleason score, and clinical stage. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients undergo high-dose intensity-modulated radiotherapy (IMRT) 4-5 times per
           week for 10 weeks (a total of 48 treatments).

        -  Arm II: Patients receive oral bicalutamide once daily for 18.5 weeks. Three to seven
           days after the initiation of bicalutamide, patients also receive goserelin
           subcutaneously monthly for 2 years. Beginning after 10 weeks of hormonal therapy,
           patients undergo concurrent high-dose IMRT 4-5 times per week for 8.5 weeks (a total of
           42 treatments). Patients discontinue bicalutamide on or near the end of radiotherapy.

      In both arms, treatment continues in the absence of disease progression or unacceptable
      toxicity.

      Quality of life is assessed at baseline, every 3 months for 1.5 years after the completion of
      radiotherapy, then 6 months later, and then annually for 2 years.

      Patients are followed every 6-8 months for 4 years and then annually for 2 years.

      PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this
      study within 4-5 years.
    

Intervention name(s): bicalutamide; goserelin acetate; assessment of therapy complications; quality-of-life assessment; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Procedure; Radiation
Intervention MeSH terms: Goserelin; Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage III prostate cancer