Short-term androgen deprivation therapy and high-dose radiotherapy in intermediate- and high-risk localized prostate cancer: Results from the GETUG 14 randomized phase III trial

Abstract

Introduction

Few studies compared short-term androgen deprivation (STADT) with high-dose radiotherapy (STADT-RT) versus high dose radiotherapy (RT) alone in localized prostate cancer.

Methods

The GETUG 14 study randomized 376 patients between RT (n = 191) and STADT-RT (n = 179). RT dose was 80 Gy in both arms and STADT was 4-month flutamide, starting 2 months before irradiation and 4-month triptorelin, starting with irradiation. Disease-free survival (DFS) was the primary endpoint. Secondary endpoints were overall survival (OS), biochemical failure-free survival (BFFS), metastasis-free survival (MFS), toxicity and quality of life.

Results

With a median follow-up of 84 months, five-year DFS was 76% in RT arm versus 84% in STADT-RT arm (hazard radio (HR) = 0.64; (95% CI 0.43–0.89); P = 0.02). ADT had a positive impact on BFS (HR = 0.45; P = 0.001) and MFS (HR = 0.5; P = 0.09) but not on OS (HR = 1.22; P = 0.54). No difference was fond in terms of gastro intestinal (26% of grade > 1 in both arm, P = 0.97) and genito-urinary toxicity (39% for RT and 42% for STADT-RT, P = 0.55). Similarly, no difference was found in quality of life.

Conclusion

STADT improves DFS in intermediate and high-risk prostate cancer patients receiving high dose (80 Gy) RT, without any deterioration in the safety profile.