ESTRO 2024 - Abstract Book

S2456

Clinical - Urology

ESTRO 2024

Purpose/Objective:

The RADIOSA trial (AIRC IG-22159, ClinicalTrials.gov identifier: NCT03940235 (1)), a monocentric phase II randomized trial, investigate the role of MDT in oligorecurrent hormone-senstive PCa patients. The aim of the study was to compare the addition of a short-course ADT to SBRT to all oligometastatic sites vs SBRT alone in terms of clinical progression-free survival (CPFS). As a final result, the purpose of the present project is to define the optimal management of bone or nodal PCa recurrences in SBRT regimen.

Material/Methods:

Oligorecurrent PCa patients with up to 3 bone or lymph-nodes lesions were randomized 1:1 to receive SBRT alone (arm A) or SBRT + 6 months of ADT (arm B). Patients were stratified according to PSA doubling time (≤3 vs >3 months), initial localization of metastases (node vs bone) and diagnostic imaging (PET vs. MRI). The primary endpoint was to compare the CPFS, defined as the absence of new metastatic lesions (local, regional, or distant) between the two arms. Biochemical progression-free survival (BPFS), overall survival (OS), ADT-free survival, local control, treatment-induced acute and late toxicity, time to castration-resistant disease, QoL between the two arms were also calculated. For the statistical analysis, Wilcoxon rank-sum tests were used to assess any differences in the baseline characteristics of patients among the two arms. Kaplan – Meyer analysis and Cox regression were performed to explore the association between prognostic factors and biochemical progression (BP) and CP.

Results:

Between September 2019 and April 2023, 100 patients were enrolled in the trial. Respectively, 50 and 50 patients were assigned to arms A and B. All patients included in the present analysis completed at least 6 months of follow up to reach the primary endpoint. Baseline population characteristics were balanced between the two arms ( Table 1 ).