Adjuvant Radiation Therapy Plus Hormone Therapy Compared With Radiation Therapy Alone in Treating Patients With Stage II or Stage III 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. Androgens can
      stimulate the growth of prostate cancer cells. Drugs such as, flutamide or bicalutamide may
      stop the adrenal glands from producing androgens. Giving radiation therapy with hormone
      therapy after surgery to remove the tumor may kill any tumor cells remaining after surgery
      and be an effective treatment for stage II or stage III prostate cancer. It is not yet known
      if radiation therapy combined with hormone therapy is more effective than either radiation
      therapy alone or hormone therapy alone in treating stage II or stage III prostate cancer.
      (Hormone therapy alone group closed as of 12/9/2002.)

      PURPOSE: Randomized phase III trial to compare the effectiveness of adjuvant radiation
      therapy plus hormone therapy to that of radiation therapy alone or hormone therapy alone in
      treating patients who have stage II or stage III prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the overall survival, disease-free survival, freedom from distant metastases,
           and freedom from PSA failure in patients with high-risk stage II or III prostate cancer
           treated in the adjuvant setting with radiotherapy and hormonal therapy vs radiotherapy
           alone.

        -  Compare the qualitative and quantitative toxic effects of these regimens in these
           patients.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      seminal vesicle invasion (yes vs no), preoperative PSA (10 ng/mL or less vs greater than 10
      ng/mL), Gleason score (2-6 vs 7 vs 8-10), positive surgical margins (yes vs no), and
      neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms.
      (Arm III closed to accrual as of 12/9/2002.)

        -  Arm I: Patients undergo radiotherapy once daily 5 days a week for 7 weeks. Beginning the
           first day of radiotherapy, patients also receive hormonal therapy comprising a
           luteinizing-hormone-releasing hormone agonist once every 1-4 months for 2 years AND oral
           flutamide 3 times daily OR oral bicalutamide once daily for 1 month.

        -  Arm II: Patients undergo radiotherapy as in arm I.

        -  Arm III (Closed to accrual as of 12/9/2002):Patients receive hormonal therapy as in arm
           I.

      Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: A total of 1,398 patients (699 per treatment arm) will be accrued for this
      study within 5 years. (Arm III closed to accrual as of 12/9/2002.)
    

Intervention name(s): bicalutamide; flutamide; releasing hormone agonist therapy; adjuvant therapy; radiation therapy
Intervention type(s): Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Bicalutamide; Flutamide; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer