Phase III randomised controlled trial on PSMA PET/CT guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancer (PERYTON-trial): study protocol

Abstract

Highlights • This is the first PSMA PET/CT based study addressing the role of hypofractionation in salvage external beam radiation therapy (sEBRT); • Participants will be randomised 1:1 to conventional fractionated sEBRT (35 × 2 Gy) or hypofractionated sEBRT (20 × 3 Gy); • The PSMA PET/CT-scan will be used for staging of all participants at baseline; • The primary endpoint is 5-year progression-free survival after treatment; • All participants will receive early sEBRT (PSA < 1.0 ng/mL) without the use of androgen deprivation therapy; • A quality assurance program was undertaken, to ensure protocol compliance within the PERYTON-trial; • An interim analysis will be performed after the inclusion of 25% (n = 135) of the total number of required participants, to identify any early signs of excessive (unexpected) acute toxicity.

Keywords

• Salvage radiotherapy
• Biochemical recurrence
• Hypofractionation
• PSMA PET/CT scan
• Prostate cancer
• Prostatectomy