RT Journal Article
SR Electronic
T1 Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility study investigating toxicity outcomes following reirradiation with stereotactic body radiotherapy (SBRT) versus high-dose-rate brachytherapy (HDR-BT)
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e068580
DO 10.1136/bmjopen-2022-068580
VO 12
IS 11
A1 Jim Zhong
A1 Sarah Brown
A1 Maria Serra
A1 Pam Shuttleworth
A1 Peter Bownes
A1 Christopher Thompson
A1 Rachel Reed
A1 Kimberley Reeves
A1 Michael Dubec
A1 Damien McHugh
A1 Cynthia Eccles
A1 Robert Chuter
A1 Yat Man Tsang
A1 N Jane Taylor
A1 Catharine West
A1 David Buckley
A1 Andrew Scarsbrook
A1 Ananya Choudhury
A1 Peter Hoskin
A1 Ann Henry
YR 2022
UL http://bmjopen.bmj.com/content/12/11/e068580.abstract
AB Introduction Radiotherapy is the most common curative treatment for non-metastatic prostate cancer; however, up to 13% of patients will develop local recurrence within 10 years. Patients can undergo further and potentially curative treatment including salvage surgery, brachytherapy (BT), external beam radiotherapy, high-intensity focused ultrasound and cryotherapy. Systematic review shows that high-dose-rate (HDR) BT and stereotactic body radiotherapy (SBRT) have the best outcomes in terms of biochemical control and lowest side effects. The reirradiation options for previously irradiated prostate cancer (RO-PIP) trial aims to determine the feasibility of recruitment to a trial randomising patients to salvage HDR-BT or SBRT and provide prospective data on patient recorded toxicity outcomes that will inform a future phase III trial.Methods and analysis The primary endpoint of the RO-PIP feasibility study is to evaluate the patient recruitment potential over 2 years to a trial randomising to either SBRT or HDR-BT for patients who develop local recurrence of prostate cancer following previous radiation therapy. The aim is to recruit 60 patients across 3 sites over 2 years and randomise 1:1 to SBRT or HDR-BT. Secondary objectives include recording clinician and patient-reported outcome measures to evaluate treatment-related toxicity. In addition, the study aims to identify potential imaging, genomic and proteomic biomarkers that are predictive of toxicity and outcome based on hypoxia status, a prognostic marker of prostate cancer.Ethics and dissemination This study has been approved by the Yorkshire and The Humber—Bradford Leeds Research Ethics Committee (Reference: 21/YH/0305, IRAS: 297060, January 2022). The results will be presented in national and international conferences, published in peer-reviewed journals and will be communicated to relevant stakeholders. A plain English report will be shared with the study participants, patients’ organisations and media.Trial registration number ISRCTN 12238218 (Amy Ackroyd NIHR CPMS Team).