Reirradiation Options for Previously Irradiated Prostate cancer (RO-PIP): Feasibility randomised clinical trial investigating toxicity outcomes following reirradiation with ultra-hypofractionated external beam radiotherapy vs. high dose rate brachytherapy

niversity of Leeds0 个研究点目标入组 60 人开始时间: 2022年7月1日最近更新: 2024年4月22日

适应症

试验速览

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36351720/ (added 10/11/2022)

•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 <50 ng/ml
•4. Baseline plasma testosterone level required
•5. Willing and able to provide informed consent
•6. Primary prostate cancer treatment must have been with external beam radiotherapy (EBRT) or brachytherapy (BT)
•7. Biochemical recurrence at least 2 years after primary radiation treatment completed
•8. Performance status WHO 0-2
•9. Reasonable urinary function (IPSS <20 and Qmax >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)

•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

发起方

niversity of Leeds