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Zhong, Jim; Brown, Sarah; Serra, Maria; Shuttleworth, Pam; Bownes, Peter; Thompson, Christopher; Reed, Rachel; Reeves, Kimberley; Dubec, Michael; McHugh, Damien; Eccles, Cynthia; Chuter, Robert; Tsang, Yat Man; Taylor, N Jane; West, Catharine; Buckley, David; Scarsbrook, Andrew; Choudhury, Ananya; Hoskin, Peter; Henry, Ann

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)

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  • Medientyp: E-Artikel
  • Titel: 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)
  • Beteiligte: Zhong, Jim; Brown, Sarah; Serra, Maria; Shuttleworth, Pam; Bownes, Peter; Thompson, Christopher; Reed, Rachel; Reeves, Kimberley; Dubec, Michael; McHugh, Damien; Eccles, Cynthia; Chuter, Robert; Tsang, Yat Man; Taylor, N Jane; West, Catharine; Buckley, David; Scarsbrook, Andrew; Choudhury, Ananya; Hoskin, Peter; Henry, Ann
  • Erschienen: BMJ, 2022
  • Erschienen in: BMJ Open
  • Sprache: Englisch
  • DOI: 10.1136/bmjopen-2022-068580
  • ISSN: 2044-6055
  • Schlagwörter: General Medicine
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>ISRCTN 12238218 (Amy Ackroyd NIHR CPMS Team).</jats:p></jats:sec>
  • Zugangsstatus: Freier Zugang