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Prostate Cancer Treatment and Research / Prostate Cancer Diagnosis and Treatment / Advanced Radiotherapy Techniques · Journal article
JAMA · August 13, 2026
Well-designed and adequately powered for the question it asks.
NRG-GU005 is a large phase 3 RCT comparing SBRT to MH-IMRT for intermediate-risk localized prostate cancer. SBRT reduced high-grade toxicity and improved bowel quality of life and some sexual/continence measures, but achieved lower 3-year disease-free survival (88.6% vs 92.1%), making it not superior overall despite quality-of-life gains.
Phase 3, international, open-label, randomized controlled trial. Patients with localized prostate cancer, clinical stage T1–T2b with Gleason 3+4 (grade group 2) and PSA <20 ng/mL or Gleason 3+3 (grade group 1) and PSA 10–20 ng/mL. A total of 698 patients enrolled across 136 centers in Asia, Canada, Europe, and United States. Median age 68 years; 3% Asian, 13% Bl…. Intervention: Stereotactic body radiotherapy (SBRT) 36.25 Gy in 5 fractions. Compared with: Moderately hypofractionated intensity-modulated radiation therapy (MH-IMRT) 70 Gy in 28 fractions or 60 Gy in 20 fractions. n = 698. 136 centers in Asia, Canada, Europe, and United States.
Urinary-irritative domain MCID at 2 years: 35.4% SBRT vs 33.7% MH-IMRT (P = 0.68, not significant) Bowel domain MCID at 2 years: 34.9% SBRT vs 43.8% MH-IMRT (P = 0.03, favoring SBRT) Grade 3+4 genitourinary adverse events: 0.6% SBRT vs 2.5% MH-IMRT (P = 0.04, favoring SBRT)
Grade 3+4 genitourinary adverse events: 0.6% SBRT vs 2.5% MH-IMRT (P = 0.04, favoring SBRT)
Clinicians should recognize that SBRT offers reduced high-grade toxicity and better bowel quality of life compared to MH-IMRT in intermediate-risk prostate cancer, but at the cost of lower disease-free survival at 3 years. Treatment choice should incorporate patient preferences regarding toxicity tolerance versus oncologic control.
Phase 3 randomized controlled trial with adequate sample size and median 3.2-year follow-up showing SBRT improved bowel quality of life and reduced high-grade genitourinary toxicity, but had lower disease-free survival than MH-IMRT.
As stated by the source record.
Quoted from the source exactly as published.
Clinicians should recognize that SBRT offers reduced high-grade toxicity and better bowel quality of life compared to MH-IMRT in intermediate-risk prostate cancer, but at the cost of lower disease-free survival at 3 years. Treatment choice should incorporate patient preferences regarding toxicity tolerance versus oncologic control.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Importance The treatment of prostate cancer with radiotherapy is evolving. How quickly radiotherapy can be delivered, and the relative risks and benefits of such a treatment, is of significant public interest. Objective To determine whether stereotactic body radiotherapy (SBRT) was superior to moderately hypofractionated intensity-modulated radiation therapy (MH-IMRT) in terms of patient-reported urinary irritative/obstructive and bowel quality of life and disease-free survival (DFS). Design, Setting, and Participants NRG-GU005 was a phase-3, international, open-label, randomized clinical trial. The study was activated on November 16, 2017, and closed to accrual on June 8, 2022. Date of last follow-up was October 13, 2024. There were 136 centers in Asia, Canada, Europe, and the United States that accrued patients to the study. Patients with localized prostate cancer, clinical stage T1-T2b with Gleason 3 + 4 (grade group 2) and prostate-specific antigen (PSA) level less than 20 ng/mL or Gleason 3 + 3 (grade group 1) and PSA level 10 to 20 ng/mL were eligible. Intended accrual of 692 patients provided reductions of 8% and 10% in minimal clinically important decline (MCID) frequency for urinary-irritative/obstructive and bowel domains of the Expanded Prostate Cancer Index Composite–26 Item (EPIC-26) instrument at 2 years and greater than 80% power to detect a hazard ratio of 0.62 in DFS. Interventions Patients were randomized 1:1 to receive SBRT (36.25 Gy in 5 fractions; n = 353) or MH-IMRT (70 Gy in 28 fractions or 60 Gy in 20 fractions; n =345). Main Outcomes and Measures Primary outcomes were the frequency of an MCID in the urinary irritative/obstructive and bowel domains of the EPIC-26 at 2 years and DFS at 3 years. Results A total of 698 patients were randomized. Median age was 68 years; 3% were Asian, 13% Black, and 80% White. Median follow-up was 3.2 years (range, 0-6.5). At 2 years, there was no significant difference in the urinary-irritative domain (35.4% vs 33.7%, P =.68). Urinary incontinence at 1 and 2 years after treatment and sexual function at 1 year after treatment favored SBRT. Fewer grade 3 + 4 genitourinary adverse events occurred in the SBRT vs MH-IMRT group (0.6% vs 2.5%, P =.04). There were significantly fewer MCIDs with SBRT vs MH-IMRT in the bowel domain (34.9% vs 43.8%, P =.03). At 3 years, DFS for MH-IMRT was 92.1% (95% CI, 88.9%-95.2%) vs 88.6% for SBRT (95% CI, 85.2%-92.1%) (1-sided log-rank P lt;.001). Conclusions and Relevance Stereotactic body radiotherapy using a modest dose prescription improved multiple quality-of-life domains but was not superior to MH-IMRT in terms of DFS. The rate of PSA failure was not significantly improved in the SBRT vs MH-IMRT group. Trial Registration ClinicalTrials.gov Identifier: NCT03367702
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