Randomized phase II trial in prostate cancer with hormone-sensitive OligometaSTatic relapse: Combining stereotactic ablative radiotherapy and durvalumab (POSTCARD GETUG P13): Study protocol.

Fiche publication

Date publication

mai 2023

Journal

Clinical and translational radiation oncology

Auteurs

Membres identifiés du Cancéropôle Est :
Dr MARTIN Etienne , Dr QUIVRIN Magali

Tous les auteurs :
Rogé M, Pointreau Y, Sargos P, Meyer E, Schick U, Hasbini A, Rio E, Bera G, Ruffier A, Quivrin M, Chasseray M, Latorzeff I, Martin E, Guimas V, Pommier P, Leroy T, Ronchin P, Lepinoy A, Grand A, Cartier L, Didas O, Denis F, Libois V, Blanc-Lapierre A, Supiot S

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/36968576

Résumé

As in other solid tumors, increasing evidence indicates that patients diagnosed with a limited number of prostate cancer metastases, so-called oligometastases, have a better prognosis than patients with extensive metastatic disease. Stereotactic body radiotherapy (SBRT) is now considered an option in this population.Programmed death-1 (PD-1) and its ligands (PD-L1) are targeted by immune checkpoint inhibitors. Preclinical studies have shown that the tumor immune microenvironment changes when combining radiotherapy with immunotherapy, especially with hypofractionated radiotherapy.The oligometastatic setting appears to be the most relevant clinical situation for evaluating the immune response generated by radiotherapy and immune checkpoint inhibitors in patients with an intact immune system.We hypothesize that durvalumab will enhance the immune response following SBRT targeting oligometastatic lesions. Our purpose is to demonstrate, via a randomized 2:1 phase II trial, that SBRT (3 fractions) with durvalumab in oligometastatic hormone-sensitive prostate cancer patients would improve progression-free survival in patients with prostate cancer with up to 5 metastases compared to patients who exclusively received SBRT.