A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk Prostate Cancer
A Phase III Randomized Study of Hypofractionated 3D-CRT/MRT Versus Conventionally Fractionated 3D-CRT/MRT in Patients With Favorable-Risk 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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to Gleason score (2-4 vs 5-6), prostate-specific antigen (PSA) level (< 4 ng/mL vs 4-<9 ng/mL), and planned radiotherapy modality (three-dimensional conformal radiotherapy [3D-CRT] vs intensity-modulated radiotherapy [IMRT]). Patients are randomized to 1 of 2 treatment arms.
Quality of life, anxiety, and depression are assessed at baseline and then at 6 months and 1, 2, and 5 years after the start of radiotherapy.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,067 patients will be accrued to this study.
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate within the past 6 months
Combined Gleason score 2-6
Prostate-specific antigen (PSA) < 10 ng/mL within the past 6 months
No regional lymph node involvement
No distant metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior radical prostatectomy or cryosurgery for prostate cancer
No prior hormonal therapy, including any of the following:
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
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