Zhong, Jim, Brown, Sarah, Serra, Maria, Shuttleworth, Pam, Bownes, Peter, Thompson, Christopher, Reed, Rachel, Reeves, Kimberley, Dubec, Michael, McHugh, Damien et al (show 10 more authors)
(2022)
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, 12 (11).
e068580-.
|
PDF
Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP) Feasibility study investigating toxicity outcomes f.pdf - Published version Download (2MB) | Preview |
Abstract
<h4>Introduction</h4>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.<h4>Methods and analysis</h4>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.<h4>Ethics and dissemination</h4>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.<h4>Trial registration number</h4>ISRCTN 12238218 (Amy Ackroyd NIHR CPMS Team).
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | Prostate disease, RADIOTHERAPY, Magnetic resonance imaging |
| Divisions: | Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Population Health Faculty of Health and Life Sciences > Institute of Population Health > School of Health Sciences |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 16 Feb 2023 14:23 |
| Last Modified: | 09 Mar 2023 02:04 |
| DOI: | 10.1136/bmjopen-2022-068580 |
| Open Access URL: | http://dx.doi.org/10.1136/bmjopen-2022-068580 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3168447 |
Dimensions
Dimensions
