Radiation Therapy in Treating Patients With Stage II Prostate Cancer

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.

Sex

Male

Minimum age

18 Years

Maximum age

120 Years

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

• RESULTLee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza DP, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Koontz BF, Paulus R, Sandler HM. Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2016 Jul 10;34(20):2325-32. doi: 10.1200/JCO.2016.67.0448. Epub 2016 Apr 4. PMID 27044935
• DERIVEDLee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, Shah AB, D'Souza D, Michalski JM, Dayes IS, Seaward SA, Hall WA, Nguyen PL, Pisansky TM, Faria SL, Chen Y, Rodgers JP, Sandler HM. Long-Term Analysis of NRG Oncology RTOG 0415: A Randomized Phase III Noninferiority Study Comparing Two Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2024 Jul 10;42(20):2377-2381. doi: 10.1200/JCO.23.02445. Epub 2024 May 17. PMID 38759121
• DERIVEDAlexander GS, Krc RF, Assif JW, Sun K, Molitoris JK, Tran P, Rana Z, Bentzen SM, Mishra MV. Conditional Risks of Biochemical Failure and Prostate Cancer-Specific Death in Patients Undergoing External Beam Radiotherapy: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Netw Open. 2023 Sep 5;6(9):e2335069. doi: 10.1001/jamanetworkopen.2023.35069. PMID 37751207
• DERIVEDKim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2. PMID 36884035
• DERIVEDBai J, Pugh SL, Eldridge R, Yeager KA, Zhang Q, Lee WR, Shah AB, Dayes IS, D'Souza DP, Michalski JM, Efstathiou JA, Longo JM, Pisansky TM, Maier JM, Faria SL, Desai AB, Seaward SA, Sandler HM, Cooley ME, Bruner DW. Neighborhood Deprivation and Rurality Associated With Patient-Reported Outcomes and Survival in Men With Prostate Cancer in NRG Oncology RTOG 0415. Int J Radiat Oncol Biol Phys. 2023 May 1;116(1):39-49. doi: 10.1016/j.ijrobp.2023.01.035. Epub 2023 Feb 2. PMID 36736921