Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may
      fight prostate cancer by reducing the production of androgens. Radiation therapy uses
      high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone
      therapy and radiation therapy is more effective for prostate cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of
      hormone therapy and radiation therapy in treating patients who have prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the efficacy of moderate-duration (28 weeks) neoadjuvant total androgen
           suppression (TAS) and radiotherapy (RT) with short-duration (8 weeks) neoadjuvant TAS
           and RT, as related to disease-specific survival, in patients with intermediate-risk
           adenocarcinoma of the prostate.

        -  Compare these regimens, in terms of overall survival, disease-free survival, time to
           local tumor progression or distant failure, time to first biochemical failure,
           hormone-refractory state, and treatment-induced morbidity, in this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater
      than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs
      5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two
      treatment arms.

        -  Arm I: Patients receive total androgen suppression for 8 weeks prior to the initiation
           of radiotherapy and throughout radiotherapy. A luteinizing hormone-releasing hormone
           (LHRH) agonist is administered every 1-3 months AND bicalutamide OR flutamide is given
           orally daily for a total duration of 16 weeks. Beginning with week 9, patients undergo
           radiotherapy 5 days a week for 8 weeks.

        -  Arm II: Patients receive total androgen suppression for 28 weeks prior to the initiation
           of radiotherapy and throughout radiotherapy. An LHRH agonist AND bicalutamide OR
           flutamide are administered as in arm I for a total duration of 36 weeks. Beginning with
           week 29, patients undergo radiotherapy 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 1,540 patients (770 per treatment arm) will be accrued for this
      study within 4 years.
    

Intervention name(s): Casodex; Eulexin; LHRH agonist; radiation therapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): Orally at a dose of one 50 mg tablet per day started within (before or after) 14 days of the first LHRH agonist injection.; Orally at a dose of two 125 mg capsules three times a day for a total daily dose of 750 mg (six capsules) started within (before or after) 14 days of the first LHRH agonist injection.; LHRH agonist of choice. The manufacturer's instructions should be followed.; [Prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin receives 70.2 Gy (1.8 Gy/day x 39 fractions, five days/week)] OR [regional nodes, prostate and seminal vesicles + 1.0-1.5 cm margin will receive 46.8 Gy (1.8 Gy/day x 26 fractions, five days/week), followed by a 23.4 Gy (1.8 Gy/day x 13 fractions, five days/week) boost to the prostate and any extraprostatic tumor extension + 1.0-1.5 cm margin]
Other intervention name(s): bicalutamide; flutamide; Zoladex; Lupron; Eligard; Viadur; luteinizing hormone-releasing hormone (LHRH)-agonist
Intervention MeSH terms: Bicalutamide; Flutamide; Hormones; Prolactin Release-Inhibiting Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer