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
F. H. E. Staal,
J. Janssen,
C. L. Brouwer,
J. A. Langendijk,
K. Ng Wei Siang,
E. Schuit,
I. J. de Jong,
J. F. Verzijlbergen,
R. J. Smeenk,
S. Aluwini
Affiliations
F. H. E. Staal
Department of Radiation Oncology, University Medical Centre Groningen
J. Janssen
Department of Radiation Oncology, University Medical Centre Groningen
C. L. Brouwer
Department of Radiation Oncology, University Medical Centre Groningen
J. A. Langendijk
Department of Radiation Oncology, University Medical Centre Groningen
K. Ng Wei Siang
Department of Radiation Oncology, University Medical Centre Groningen
E. Schuit
Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University
I. J. de Jong
Department of Urology, University Medical Centre Groningen
J. F. Verzijlbergen
Department of Nuclear Medicine, Radboud University Nijmegen Medical Centre
R. J. Smeenk
Department of Radiation Oncology, Radboud University Nijmegen Medical Centre
S. Aluwini
Department of Radiation Oncology, University Medical Centre Groningen
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.
