GETUG-AFU 31: a phase I/II multicentre study evaluating the safety and efficacy of salvage stereotactic radiation in patients with intraprostatic tumour recurrence after external radiation therapy-study protocol

BMJ Open
David PasquierEric Lartigau

Abstract

Prostate cancer is the third most important cancer in terms of mortality in men. No standard local treatment exists for patients with an intraprostatic recurrence after radiotherapy. Stereotatic body radiotherapy (SBRT) could be a curative treatment for local recurrence. The phase I/II primary objective is the selection of the recommended dose for salvage-SBRT and to estimate the efficacy. We plan to perform a multicentre prospective phase I/II study including at least 47 patients. Eligible patients are patients with biochemical recurrence occurring at least 2 years after external radiotherapy for prostatic adenocarcinoma by the Phoenix definition (prostate-specific antigen (PSA) nadir +2 ng/mL) and histologically proven intraprostatic recurrence only (stage T1-T2 on relapse, PSA level ≤10 ng/mL, PSA doubling time >10 months, absence of pelvic or metastatic recurrence proven by choline or PSMA positron emission tomography scan, and pelvic and prostatic assessment by multiparametric MRI). The phase I primary objective is the selection of the recommended dose for salvage-SBRT (5×6, 6×6 or 5×5 Gy) based on dose-limiting toxicity (DLT). The dose of salvage-SBRT will be selected using a time-to-event continual reassessment method ba...Continue Reading

Citations

Dec 23, 2020·Progrès en urologie : journal de l'Association française d'urologie et de la Société française d'urologie·F RozetA Méjean
May 10, 2021·Cancer Treatment Reviews·Barbara A Jereczek-FossaUNKNOWN on the behalf of the European Society for Radiotherapy, Oncology Advisory Committee on Radiation Oncology Practice (ESTRO AC
May 25, 2021·Journal of Medical Radiation Sciences·Matthew RichardsonJarad Martin

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