Study ID: NRG GU005
Phase III IGRT and SBRT vs. IGRT and hypofractionated IMRT for localized intermediate-risk prostate cancer
The researchers are testing stereotactic body radiation therapy (SBRT) compared to intensity-modulated radiation therapy (IMRT). SBRT is a specialized radiation therapy that sends X-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. IMRT uses linear accelerators to deliver precise radiation doses to a tumor while minimizing the dose to surrounding normal tissue.
Participants are grouped into two study arms: One undergoes IMRT once daily over less than 32 business days, while the other group undergoes SBRT at least every other day over less than 12 business days.
This randomized, phase III study seeks to determine if stereotactic body radiation therapy (SBRT) is superior to hypofractionated intensity-modulated radiation therapy (IMRT) in terms of genitourinary and gastrointestinal toxicity by having fewer patients who experience a decline in urinary irritation/obstruction and bowel Health Related Quality of Life (HRQOL) as measured by Expanded Prostate Cancer Index Composite (EPIC)-26 at 24 months post completion of therapy.
- Previously untreated localized adenocarcinoma of the prostate with the following clinical findings: clinical stage by DRE of either T1c or T2a/b (limited to one side of the gland); AJCC, version 7) or cT1a-c or 2a or 2b, stage group IIA or IIB (AJCC, version 8); both versions 7 and 8 staging should be recorded
- Stages T1a-T1b eligible if patient underwent TURP previously. Gleason score must be 7(3+4) with a PSA < 20 ng/mL, or 6(3+3) with a PSA > 10 ng/mL and < 20 ng/mL; (AJCC, version 7) or group grade 1 or 2, stage Group IIA or IIB (AJCC version 8)
- The prostate volume must be < 60 cc as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan
- Must have been diagnosed with stage IIA-B prostate cancer
- Must agree to follow-up care for two years after therapy