Some patients undergoing prostatectomy develop biochemical recurrence or have persistently detectable prostate-specific antigen level. Salvage radiotherapy (RT), delivered over ≥4 wk, is a current standard of care. Our objective was to demonstrate that salvage RT delivered in a five-fraction stereotactic body radiotherapy (SBRT) regimen does not significantly increase patient-reported genitourinary (GU) and gastrointestinal (GI) symptoms compared with a 20-fraction regimen (HYPO).
In this randomized noninferiority study, 137 patients were randomized 1:1 to salvage RT with 32.5 Gy in five fractions or 55 Gy in 20 fractions. We report acute changes in Expanded Prostate Cancer Index Composite (EPIC) scores and Common Terminology Criteria for Adverse Events at 3 and 6 mo.
The difference in the changes in EPIC GU scores between SBRT and HYPO was 3.3 (95% confidence interval [CI], -8.53, 1.93), indicating a lack of a clinically meaningful difference. The difference in the changes in EPIC GI scores between SBRT and HYPO was 1.16 (95% CI, -5.15, 7.46), indicating a lack of a clinically meaningful difference.
Salvage RT delivered in five fractions was not associated with a significantly worse decline in patient-reported GU or GI toxicities at 3 or 6 mo. Further follow-up is necessary to monitor for potential differences in late toxicity and patient-reported outcomes.
European urology oncology. 2025 Jun 09 [Epub ahead of print]
Himanshu Nagar, Marshall A Diven, Brady Rippon, Christopher E Barbieri, Jim C Hu, Douglas S Scherr, Pragya Yadav, Lhaden Tshering, Sharanya Chandrasekhar, Sydney Wolfe, Ryan Pennell, Madeline Coonce, Shu Ling Chen, Silvia C Formenti, Paul Strong, Elai Davicioni, Ana M Molina, David M Nanus, Jones T Nauseef, Cora N Sternberg, Xi K Zhou, Wanna Lei, Joseph R Osborne, Ariel E Marciscano, Scott T Tagawa
Weill Cornell Medicine, New York, NY, USA; Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: ., NewYork-Presbyterian, Brooklyn Methodist Hospital, Brooklyn, NY, USA., Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA., NewYork-Presbyterian Hospital, Weill Cornell Medical College, New York, NY, USA., Weill Cornell Medicine, New York, NY, USA., Department of Radiation Oncology, Weill Cornell Medicine, New York, NY, USA., Sandra and Edward Meyer Cancer Center, Weill Cornell Medicine, New York, NY, USA., Hyperfine, Inc., Guilford, CT, USA., Veracyte, Inc., San Francisco, CA, USA., Weill Cornell Medicine, New York, NY, USA; Englander Institute for Precision Medicine, New York, NY, USA., Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA, USA.