Radiation Therapy in Treating Patients With Stage II Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Conventional 3D-CRT or IMRT; Hypofractionated 3D-CRT or IMRT
Intervention description: Radiation therapy will be given once daily, five days a week, at 1.8 Gy per fraction, for 41 fractions and a total dose of 73.8 Gy; Radiation therapy will be given once daily, five days a week, at 2.5 Gy per fraction, for 28 fractions and a total dose of 70 Gy.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1116.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer

Summary:

      RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to
      help focus thin beams of radiation directly on the tumor, and giving hypofractionated
      radiation therapy (higher doses over a shorter period of time), may be less costly with fewer
      side effects and just as effective in treating prostate cancer.

      PURPOSE: This randomized phase III trial is studying several different radiation therapy
      regimens to compare how well they work in treating patients with stage II prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate within the past 6 months

               -  Clinical stage T1-2c

          -  Combined Gleason score 2-6

          -  Prostate-specific antigen (PSA) < 10 ng/mL within the past 6 months

               -  PSA evaluated at least 10 days after prostate biopsy

               -  For patients who received finasteride, PSA evaluated at least 30 after completion
                  of finasteride

               -  For patients who received dutasteride, PSA evaluated at least 90 after completion
                  of dutasteride

          -  No regional lymph node involvement

          -  No distant metastases

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  No unstable angina and/or congestive heart failure requiring hospitalization within
             the past 6 months

          -  No transmural myocardial infarction within the past 6 months

          -  No acute bacterial or fungal infection requiring IV antibiotics

          -  No chronic obstructive pulmonary disease exacerbation or other respiratory illness
             requiring hospitalization or precluding study treatment

          -  No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

          -  No known AIDS

          -  No prior or concurrent lymphomatous/hematogenous malignancy or other invasive
             malignancy except nonmelanomatous skin cancer or any other cancer for which the
             patient has been continually disease-free for ≥ 5 years (e.g., carcinoma in situ of
             the bladder or oral cavity)

          -  No other severe, active comorbidity

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior radical prostatectomy or cryosurgery for prostate cancer

          -  No prior hormonal therapy, including any of the following:

               -  Luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide)

               -  Antiandrogens (e.g., flutamide or bicalutamide)

               -  Estrogens [e.g., diethylstilbestrol (DES)]

               -  Surgical castration (bilateral orchiectomy)

          -  No prior pelvic radiotherapy or prostate brachytherapy

          -  No prior or concurrent cytotoxic chemotherapy for prostate cancer

          -  At least 30 days since prior finasteride

          -  At least 90 days since prior dutasteride

          -  No concurrent neoadjuvant or adjuvant hormonal therapy

          -  Concurrent warfarin or other blood-thinning agents allowed