Radiation Therapy in Treating Patients With Prostate Cancer
Condition: Prostate Cancer; Psychosocial Effects of Cancer and Its Treatment; Radiation Toxicity; Sexual Dysfunction
MeSH terms: Prostatic Neoplasms
Intervention: 36.25 Gy IMRT; 51.6 Gy IMRT
Intervention description: 36.25 Gy in 5 fractions of 7.5 Gy twice a week over 15-17 days. A minimum of 72 hours and a maximum of 96 hours will separate each treatment. IMRT or similar techniques that use inverse treatment planning or protons are required.; 51.6 Gy in 12 fractions of 4.3 Gy 5 days a week over 16-18 days. IMRT or similar techniques that use inverse treatment planning or protons are required.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 255.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radiation toxicity; sexual dysfunction; psychosocial effects of cancer and its treatment; adenocarcinoma of the prostate; stage I prostate cancer; stage IIA prostate cancer

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized
      radiation therapy that delivers a high dose of radiation directly to the tumor may kill more
      tumor cells and cause less damage to normal tissue. Given radiation therapy in different ways
      may kill more tumor cells.

      PURPOSE: This randomized phase II trial studies radiation therapy to see how well it works in
      treating patients with prostate cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed diagnosis of adenocarcinoma of the prostate within 180 days
             of randomization

               -  History/physical examination with digital rectal examination of the prostate
                  within 60 days prior to registration

               -  Histological evaluation of prostate biopsy with assignment of a Gleason score to
                  the biopsy material; Gleason scores 2-6 within 180 days of randomization

               -  Clinical stage T1-2a (AJCC 7th edition) within 90 days of randomization

               -  Prostate-specific antigen (PSA) < 10 ng/mL within 60 days prior to registration;

                    -  PSA should not be obtained within 10 days after prostate biopsy

          -  No evidence of distant metastases

          -  No regional lymph node involvement

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Willingness and ability to complete the Expanded Prostate Cancer Index Composite
             (EPIC) questionnaire

          -  No prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or
             lymphomatous/hematogenous malignancy unless continually disease-free for a minimum of
             5 years (for example, carcinoma of the oral cavity is permissible; however, patients
             with prior history of bladder cancer are not allowed)

          -  No severe, active co-morbidity, defined as follows:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the last 6 months

               -  Transmural myocardial infarction within the last 6 months

               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time
                  of registration

               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study therapy at the time of registration

               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

                    -  Laboratory tests for liver function and coagulation parameters are not
                       required for entry into this protocol

               -  Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease
                  Control (CDC) definition

                    -  HIV testing is not required for entry into this protocol

                    -  Protocol-specific requirements may also exclude immuno-compromised patients

        PRIOR CONCURRENT THERAPY:

          -  No prior radical surgery (prostatectomy), cryosurgery, or high-intensity focused
             ultrasonography (HIFU) for prostate cancer

          -  No prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy

          -  No prior hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH)
             agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix),
             anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol
             (DES)), or surgical castration (orchiectomy)

          -  No finasteride within 30 days prior to registration

               -  Prostate-specific antigen (PSA) should not be obtained prior to 30 days after
                  stopping finasteride

          -  No dutasteride within 90 days prior to registration

               -  PSA should not be obtained prior to 90 days after stopping dutasteride

          -  No prior or concurrent cytotoxic chemotherapy for prostate cancer

          -  Patients on Coumadin or other blood-thinning agents are eligible for this study

          -  No concurrent 3D-conformal radiation therapy