Radiation Therapy in Treating Patients With Prostate Cancer
Prostate Cancer, Psychosocial Effects of Cancer and Its Treatment, Radiation Toxicity

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring radiation toxicity, sexual dysfunction, psychosocial effects of cancer and its treatment, adenocarcinoma of the prostate, stage I prostate cancer, stage IIA 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
Sites / Locations
- UAB Comprehensive Cancer Center
- Arizona Center for Cancer Care - Peoria
- Arizona Oncology Services Foundation
- Kaiser Permanente - Division of Research - Oakland
- Rohnert Park Cancer Center
- Kaiser Permanente Medical Center - Roseville
- UCSF Helen Diller Family Comprehensive Cancer Center
- Kaiser Permanente Santa Clara Medical Center
- Kaiser Permanente Medical Center - South San Francisco
- Urology Center of Colorado
- Emory Crawford Long Hospital
- Winship Cancer Institute of Emory University
- Queen's Cancer Institute at Queen's Medical Center
- Boston University Cancer Research Center
- Beth Israel Deaconess Medical Center
- Mayo Clinic Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Case Comprehensive Cancer Center
- Oklahoma University Cancer Institute
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Rosenfeld Cancer Center at Abington Memorial Hospital
- Rothman Specialty Hospital
- Fox Chase Cancer Center Buckingham
- Academic Urology Prostate Center
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Fox Chase Cancer Center - Philadelphia
- Hollings Cancer Center at Medical University of South Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- University of Virginia Cancer Center
- Columbia-Saint Mary's Cancer Care Center
- Medical College of Wisconsin Cancer Center
- Cross Cancer Institute at University of Alberta
- Margaret and Charles Juravinski Cancer Centre
- Grand River Regional Cancer Centre at Grand River Hospital
- London Regional Cancer Program at London Health Sciences Centre
- Hopital Notre-Dame du CHUM
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
5 Fractions
12 Fractions
36.25 Gy IMRT in 5 fractions over two and a half weeks
51.6 Gy IMRT in 12 fractions over two and a half weeks