PURPOSE: @entity1 with biochemical failure (BF) after radical prostatectomy may benefit from dose-intensified salvage radiation therapy (SRT) of the prostate bed. We performed a randomized phase III trial assessing dose intensification. @entity1 AND METHODS: @entity1 with BF but without evidence of macroscopic disease were randomly assigned to either 64 or 70 Gy. Three-dimensional conformal radiation therapy or intensity-modulated radiation therapy/rotational techniques were used. The primary end point was freedom from BF. Secondary end points were acute @entity137 according to the National @entity5 Institute Common Terminology Criteria for Adverse Events (version 4.0) and quality of life (QoL) according to the European Organisation for Research and Treatment of @entity5 Quality of Life Questionnaires C30 and PR25. RESULTS: Three hundred fifty @entity1 were enrolled between February 2011 and April 2014. Three @entity1 withdrew informed consent, and three @entity1 were not eligible, resulting in 344 @entity1 age 48 to 75 years in the safety population. Thirty @entity1 (8.7%) had grade 2 and two @entity1 (0.6%) had grade 3 genitourinary (GU) baseline symptoms. Acute grade 2 and 3 GU @entity137 was observed in 22 @entity1 (13.0%) and one @entity1 (0.6%), respectively, with 64 Gy and in 29 @entity1 (16.6%) and three @entity1 (1.7%), respectively, with 70 Gy (P = .2). Baseline grade 2 @entity137 was observed in one @entity1 (0.6%). Acute grade 2 and 3 @entity137 was observed in 27 @entity1 (16.0%) and one @entity1 (0.6%), respectively, with 64 Gy, and in 27 @entity1 (15.4%) and four @entity1 (2.3%), respectively, with 70 Gy (P = .8). Changes in early QoL were minor. @entity1 receiving 70 Gy reported a more pronounced and clinically relevant worsening in urinary symptoms (mean difference in change score between arms, 3.6; P = .02). CONCLUSION: Dose-intensified SRT was associated with low rates of acute grade 2 and 3 GU and @entity137 . The impact of dose-intensified SRT on QoL was minor, except for a significantly greater worsening in urinary symptoms.

Acute XXXX and Quality of Life After Dose-Intensified Salvage Radiation Therapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: First Results of the Randomized Trial SAKK 09/10.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'GI toxicity'] @entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer']
@entity137 :: (MESH:D064420,Disease) :: ['Toxicity']
