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
Staal, F H E; Janssen, J; Brouwer, C L; Langendijk, J A; Ng Wei Siang, K; Schuit, E; de Jong, I J; Verzijlbergen, J F; Smeenk, R J; Aluwini, S
(2022) BMC Cancer, volume 22
(Article)
Abstract
Background: Salvage external beam radiotherapy (sEBRT) for patients with a biochemical recurrence (BCR) after radical prostatectomy provides a 5-year biochemical progression-free survival up to 60%. Multiple studies have shown that dose escalation to the primary prostate tumour improves treatment outcome. However, data is lacking on the role of dose escalation
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in the recurrent salvage setting. The main objective of the PERYTON-trial is to investigate whether treatment outcome of sEBRT for patients with a BCR after prostatectomy can be improved by increasing the biological effective radiation dose using hypofractionation. Moreover, patients will be staged using the PSMA PET/CT scan, which is superior to conventional imaging modalities in detecting oligometastases. Methods: The PERYTON-study is a prospective multicentre open phase III randomised controlled trial. We aim to include 538 participants (269 participants per treatment arm) with a BCR after prostatectomy, a PSA-value of < 1.0 ng/mL and a recent negative PSMA PET/CT scan. Participants will be randomised in a 1:1 ratio between the conventional fractionated treatment arm (35 × 2 Gy) and the experimental hypofractionated treatment arm (20 × 3 Gy). The primary endpoint is the 5-year progression-free survival after treatment. The secondary endpoints include toxicity, quality of life and disease specific survival. Discussion: Firstly, the high rate of BCR after sEBRT may be due to the presence of oligometastases, for which local sEBRT is inappropriate. With the use of the PSMA PET/CT before sEBRT, patients with oligometastases will be excluded from intensive local treatment to avoid unnecessary toxicity. Secondly, the currently applied radiation dose for sEBRT may be too low to achieve adequate local control, which may offer opportunity to enhance treatment outcome of sEBRT by increasing the biologically effective radiotherapy dose to the prostate bed. Trial registration: This study is registered at ClinicalTrials.gov (Identifier: NCT04642027). Registered on 24 November 2020 – Retrospectively registered. The study protocol was approved by the accredited Medical Ethical Committee (METc) of all participating hospitals (date METc review: 23-06-2020, METc registration number: 202000239). Written informed consent will be obtained from all participants.
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Keywords: Biochemical recurrence, Hypofractionation, PSMA PET/CT scan, Prostate cancer, Prostatectomy, Salvage radiotherapy, Oncology, Genetics, Cancer Research
ISSN: 1471-2407
Publisher: BioMed Central
Note: Funding Information: This work was supported and sponsored by Dutch Cancer Society (KWF Kanker Bestrijding grant number 12649). The study protocol has undergone full external peer review by the funding body as part of the peer review process. Funding Information: We thank all scientific staff; Prof. dr. Jourik Gietema,1Dr. Walter Noordzij2, drs. Christian Hammer,3Dr. Derya Yakar4and Dr. Alphonsus van den Bergh.3We also thank the participating centres and their local investigators; Ben Vanneste,5Tom Budiharto,6Dorien Haverkort,7Marianne de Jong,8Birgit Hollman,9Mariska van der Sande10and Robert Jan Smeenk.111University Medical Centre Groningen, Medical Oncology, Groningen, the Netherlands.2University Medical Centre Groningen, dept. Of Nuclear Medicine, Groningen, the Netherlands.3University Medical Centre Groningen, dept. Of Radiation Oncology, Groningen, the Netherlands.4University Medical Centre Groningen, dept. Of Radiology, Groningen, the Netherlands.5Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht, the Netherlands.6Catharina Hospital, Radiation Oncology, Eindhoven, The Netherlands.7Radiotherapiegroep, Radiation Oncology, Arnhem/Deventer, The Netherlands.8Radiotherapeutic Institute Friesland, Radiation Oncology, Leeuwarden, The Netherlands.9Haga Hospital in The Hague, dept. Of Radiation Oncology, Den Haag, the Netherlands.10Institute Verbeeten, dept. Of Radiation Oncology, Tilburg, The Netherlands.11Radboud University Medical Centre, dept. Of Radiation Oncology, Nijmegen, The Netherlands. Publisher Copyright: © 2022, The Author(s).
(Peer reviewed)