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)

BMJ Open. 2022 Nov 8;12(11):e068580. doi: 10.1136/bmjopen-2022-068580.

Abstract

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).

Keywords: Magnetic resonance imaging; Prostate disease; RADIOTHERAPY.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Brachytherapy* / adverse effects
  • Brachytherapy* / methods
  • Feasibility Studies
  • Humans
  • Male
  • Prospective Studies
  • Prostatic Neoplasms* / pathology
  • Proteomics
  • Radiosurgery* / adverse effects
  • Radiosurgery* / methods
  • Radiotherapy Dosage
  • Re-Irradiation*

Associated data

  • ISRCTN/ISRCTN12238218