Prostate cancer Cancer
Conditions
Interventions
Phase 1- Recruitment and registration:
This two-arm randomised (1:1) feasibility study will aim to prospectively recruit 30 patients over 24 months into each treatment arm (BT and SABR) giving a total
Sponsors
University of Leeds
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Biopsy-proven locally recurrent prostate cancer 3. T1-3 N0 M0 Any Gleason/ISUP grade group adenocarcinoma prostate with most recent PSA 0 ml/s on flow tests) 10. > 10-year life expectancy 11. No metastatic disease (PET-CT - any of choline/fluciclovine/PSMA) 12. No prior prostatectomy (TURP >3 months before randomisation is acceptable) 13. No history of inflammatory bowel disease 14. Suitable for procedure under general anaesthesia 15. Androgen Deprivation Therapy may be initiated at the discretion of the treating oncologist but this must be started at the time of the first salvage radiotherapy treatment (at first fraction of EBRT or at HDR-BT)
Exclusion criteria
Exclusion criteria: 1. Not compliant with any inclusion criteria 2. Do not have a prostate biopsy confirming locally recurrent prostate cancer or who are unfit for a prostate biopsy 3. Unfit for a general anaesthetic due to other comorbidities 4. Contraindications to MRI 5. Clinical or radiological evidence of metastatic prostate disease 6. Medical or psychiatric condition that impairs their ability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility measured using overall, and recruitment site-specific recruitment rates collected monthly over the 24-month recruitment period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Toxicity following salvage ultra-hypofractionated external beam radiotherapy (EBRT) or high-dose rate brachytherapy (HDR-BT) to inform future RCT design will be measured using: 1.1. Patient-reported outcome measures (PROMs) in terms of impact on quality of life and urinary, bowel, and sexual function using the EPIC-26, EORTC QLQ-C30, and IPSS questionnaires at baseline, 1, 3, 6, 12, and 24 months 1.2 Clinician-reported toxicity outcomes collected using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 at baseline, 1, 3, 6, 12, 18, and 24 months 2. Identification of MRI biomarkers that may be predictive of genitourinary and gastrointestinal toxicity (measured by PROMs as detailed above) using multiparametric MRIs at baseline and at 1-month and 1-year post-treatment 3. Image quality and repeatability of prostate functional imaging for detecting hypoxia measured using the diffusion coefficient (D), perfusion fraction (f), and pseudo-diffusion coefficient (D*) on IVIM sequences and the rate of relaxation per second (R2*) on BOLD sequences at 1-month and 1-year post-treatment 4. Changes in a hypoxia-associated gene signature and proteomic/cytokine signatures following primary radiation (and exploration of the prognostic value of such changes) measured using blood and urine samples collected at baseline and 1, 3, and 6 months after radiation treatment | — |
Countries
United Kingdom
Outcome results
None listed