Dose-intensified Versus Conventional-dose Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: Long-term Data from the SAKK 09/10 Randomised Phase 3 Trial
Year: 2026
Type: article
Abstract: We report long-term outcomes from the phase 3 SAKK 09/10 trial that randomly assigned men with biochemical progression after radical prostatectomy to conventional-dose (64 Gy) or dose-intensified (70 Gy) salvage radiotherapy (SRT) to the prostate bed without hormonal therapy. The primary endpoint was freedom from biochemical progression (FFBP). Secondary endpoints included clinical progression-free survival (PFS), time to hormonal treatment, overall survival (OS), and late toxicity. Between February 2011 and April 2014, 350 patients were randomly assigned (175 per arm). Median prostate-specific antigen (PSA) at randomization was 0.3 ng/ml. After median follow-up of 8.6 yr, median FFBP was 8.7 yr (95% confidence interval [CI] 7.1-not reached [NR]) after 64 Gy and 8.7 yr (95% CI 6.7-NR) after 70 Gy (log-rank p = 0.87), with a hazard ratio of 1.03 (95% CI 0.75-1.41). There was no significant difference in clinical PFS, time to hormonal treatment, or OS. While late genitourinary toxicity did not significantly differ between the arms, late grade 2 and 3 gastrointestinal toxicity was more frequent with 70 Gy (p = 0.015). After long-term follow-up dose-intensified SRT was not superior to conventional-dose SRT, but was associated with a higher rate of late grade ≥2 gastrointestinal toxicity. PATIENT SUMMARY: The optimal radiotherapy dose for patients who have higher levels of tumor markers after surgery for prostate cancer is unclear. Our long-term follow-up confirms that a higher dose only increases the chances of gastrointestinal side effects without providing any benefits to the patient. This trial is registered on ClinicalTrials.gov as NCT01272050.
Source: European Urology
Authors: Pirus Ghadjar, Stefanie Hayoz, Daniel R. Zwahlen, Tobias Hölscher, Winfried Arnold, Bülent Polat, Guido Hildebrandt, Elgin Hoffmann, Ludwig Plasswilm, Alexandros Papachristofilou, Corinne Schär, Marcin Sumila, Kathrin Zaugg, Matthias Guckenberger, Piet Ost, Christiane Reuter, Davide G. Bosetti, Kaouthar Khanfir, Oliver Riesterer, Marcus Beck, George N. Thalmann, Daniel M. Aebersold
Institutions: University of Bern, University Hospital of Bern, Swiss Group For Clinical Cancer Research, Kantonsspital Graubünden, University Hospital Carl Gustav Carus, Technische Universität Dresden, Luzerner Kantonsspital, University of Würzburg, Universitätsklinikum Würzburg, Universitätsmedizin Rostock, University of Rostock, Universitätsklinikum Tübingen, University of Tübingen, Kantonsspital St. Gallen, University Hospital of Basel, Klinik Hirslanden, Hirslanden Private Hospital Group, Triemli Hospital, University Hospital Zurich, Ghent University Hospital, Kantonsspital Münsterlingen, Istituto Oncologico della Svizzera Italiana, Hôpital du Valais, Kantonsspital Aarau, Charité - Universitätsmedizin Berlin
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,250
OpenAlex ID: W7118988522