Vienna, Austria

ESTRO 2023

Session Item

May 14
10:30 - 11:30
Plenary Hall
Daniel Matthias Aebersold, Switzerland;
Johannes Knoth, Austria
Proffered Papers
10:50 - 11:00
GETUG-AFU 22 phase II randomized trial : final results on clinical outcomes with immediate SRT
igor Latorzeff, France


GETUG-AFU 22 phase II randomized trial : final results on clinical outcomes with immediate SRT

igor Latorzeff1, stephane Guerif2, florence Castan3, emmanuel Meyer4, stephane Supiot5, edouard Lagneau6, elisabeth Deniaud-Alexandre7, philippe Ronchin8, ahmed Benyoucef9, lysian Cartier10, hadji Hamidou11, ali Hasbini12, gilles Crehange13, pascal Pommier14, Anne Bareille Saint Gaudens15, malik Zibouche16, emmanuel Gross17, guillaume Ploussard18, laurent Salomon19, paul Sargos20

1Groupe ONCORAD Garonne, Pasteur Clinic, Radiation Oncology, Toulouse, France; 2Poitiers University Hospital, Radiation Oncology, Poitiers, France; 3ICM Regional Cancer Institute of Montpellier, Statistics, Montpellier, France; 4Francois Baclesse Institute, Radiation Oncology, Caen, France; 5René Gauducheau Cancer Center, Radiation Oncology, Saint Herblain, France; 6Oncology and Radiotherapy Center, Radiation Oncology, Dijon, France; 7Hospital Center of Vendée, Radiation Oncology, La Roche Sur Yon, France; 8Azuréen Cancer Center, Radiation Oncology, Mougins, France; 9Henri Becquerel Cancer Center, Radiation Oncology, Rouen, France; 10Sainte Catherine Institute, Radiation Oncology, Avignon, France; 11Paul Papin Cancer Center, Radiation Oncology, Angers, France; 12Pasteur Clinic, Radiation Oncology, Brest, France; 13Georges François Leclerc Cancer Center, Radiation Oncology, Dijon, France; 14Léon Bérard Cancer Center, Radiation Oncology, Lyon, France; 15University Institute of Cancerology and Hematology, Radiation Oncology, Saint Etienne, France; 16Unicancer, Clinical research, Paris, France; 17Ramsay Générale de santé, Private hospital Clairval, Radiation Oncology, Marseille, France; 18Croix du Sud Clinic, Urology, Toulouse, France; 19Henri Mondor Hospital - APHP, Urology, Creteil, France; 20Bergonié Institute, Radiation Oncology, Bordeaux, France

Show Affiliations
Purpose or Objective

The standard of care for patients with localized prostate cancer is radical prostatectomy (RP) but no recommendations exist for patients with persistently elevated prostate-specific antigen (PSA) after RP. The aim of this trial was to compare immediate salvage radiation therapy (iSRT) with or without short-term androgen deprivation therapy (ADT) in these patients and to select the most effective arm.

Material and Methods

RP patients with non metastatic PCa on conventional preoperative imaging, and with a post-RP PSA level between 0.2 and 2 ng/mL were randomized (1:1) to iSRT alone (iSRT arm) or 6 months of ADT (degarelix) with iSRT (iSRT+ADT arm). ISRT consisted of pelvic irradiation (46 Gy in 23 Fr) with a boost on the prostate bed (66 Gy in 33 Fr). The primary endpoint was event-free survival (EFS). Biochemical progression-free survival (bPFS), metastates-free survival (MFS), overall survival (OS), quality of life, and toxicities were evaluated as secondary endpoints. With a pick the winner design, 122 pts were required to select the most effective arm with the probability > 80% (82% according to Liu's formula) for a 20% reduction in the instantaneous risk ratio (HR=0.80)


From Jan-2013 to Sept-2015, 125 pts were included (iSRT arm: 64 pts; iSRT+ADT arm: 61). Median follow up was 74.94 months (95% CI: 74.1-76.6). Median PSA was 0.6 ng/mL (0.12-3.65) at randomization. At 5 years. EFS rate was 62.3% (95% CI: 48.9-73.2) in iSRT arm and 63.5% (95% CI: 49.9-74.2) in iSRT+ADT arm (HR=0.83; 95%CI: 0.47-1.47; p=0.528). bPFS rate was 62.3% (95% CI: 48.9-73.2) in iSRT arm and 66% (95% CI: 52.3-76.6) in iSRT+ADT arm (HR=0.76; 95%CI: 0.44-1.31; p=0.322). MFS was in favor of the iSRT+ADT arm with HR=0.51 (95% CI: 0.26-0.99; p=0.048). OS data were not mature at the time of analysis. In a multivariate analysis, PSA level <0.6 ng/ml at randomization and tumor ≤pT3a were were significant good prognostic factors for bPFS (HR=0.56; 95%CI: 0.31-1.01; p=0.05 and HR=0.33; 95%CI: 0.19-0.58; p=0.0002, respectively). ISRT alone and PSA level <0.6 ng/ml at randomization were good prognostic factors for MFS (HR=0.39; 95%CI: 0.16-0.93; p=0.03 and HR=0.36; 95%CI: 0.14-0.88; p=0.019, respectively) in multivariate analysis. No grade 4 toxicities were observed. Overall, no difference in acute toxicity were observed between the 2 arms and more late toxicities (≥6 months after iSRT) were observed in the iSRT+ADT than the iSRT arm (53.1% vs 70.5%; p=0.046). At 12 months ADT-related symptoms were more important in the iSRT+ADT arm (QLQ-PR25; p=0.04). At 24 months, no difference in QLQ-C30 or QLQ-PR25 analysis was reported. After an initial 25-fold decrease in blood testosterone level, all patients recovered to normal level 12 months after starting ADT


This study demonstrated that iSRT+ADT is the most effective arm and improved MFS with good tolerance for patients with persistently elevated PSA after RP. iSRT+ADT may be used as reference arm for a phase III study.