Late Toxicity And Quality Of Life From Getug-Afu 22 Study: A Multicenter Randomized Phase Ii Trial Comparing Radiotherapy +/-6 Months Of Degarelix As A Salvage Treatment For Patients With Detectable Psa After Radical Prostatectomy

No recommendations exist for patients with immediate detectable prostate-specific antigen (PSA) after radical prostatectomy. We will describe the toxicity and quality of life results in adding hormone therapy (HT) to radiotherapy (RT) for patients with detectable PSA after radical prostatectomy. Patients with localized prostate cancer, treated by radical prostatectomy (R0 or R1), with a PSA-level post- radical prostatectomy ≥0.2 ng/mL and ≤2 ng/mL at randomization and N0 M0 on imaging were included. Patients were randomized (1:1) to RT alone (RT arm) or 6 months of degarelix HT with RT (RT+HT arm). RT consisted of pelvic irradiation (46 Gy in 23 fractions [Fr]) with a boost on the prostate bed (66 Gy in 33 Fr). The primary endpoint was event-free survival. Acute and late toxicities were evaluated as secondary endpoints and scored using CTCAE v4.0. Quality of life (QoL) was assessed with QLQ-C30 and QLQ-PR25 questionnaires at 12 and 24 months. Late toxicity was reported at 24 months. From Jan-2013 to Sept-2015, 125 patients were included (RT arm: 64 patients; RT+HT arm: 61 patients). Median follow up was 38 months (95% CI: 31.4-44.1). The baseline characteristics were well-balanced between both arms: median age was 66 years (50-77), performance status was ECOG 0 92%, median Gleason score was 7 (3-9), median PSA level was 0.3 ng/mL (0.09-1.82) post- radical prostatectomy and 0.6 ng/mL (0.12-3.65) at randomization. All patients received 33 Fr of RT. In the RT+HT arm, 98.4% of patients received the 6 months of HT planned. Safety was analyzed in all patients. At 24 months, no difference in late genitourinary (GU) or gastrointestinal (GI) toxicity was observed between both arms (p=0.145). Grade 3 late toxicities were reported for 15/125 patients (12%): 8/64 (6.5%) in the RT arm and 7/61 (5.5%) in RT+HT arm (not significant) and no toxicity grade >3 was observed. QoL was evaluated at 12 months of follow up in 80% of patients in RT arm 89% in RT+HT arm, and at 24 months for 59% and 77% of patients. At 12 months HT related symptoms were more important in the RT+HT arm (p=0.04). At 24 months no difference in QLQC-30 or QLQ-PR25 analysis was reported. In this phase II trial, at 24 months no difference in GI/GU toxicity and QoL was observed between both arms. GETUG-AFU 22 efficacy analysis is still pending.