Retreating localised prostate cancer with either repeat radiotherapy or brachytherapy

Not Applicable

• Conditions: Cancer; Prostate cancer

• Registration Number: ISRCTN12238218
• Lead Sponsor: niversity of Leeds

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Last Update Posted: 22 April 2024
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 60

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 <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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility measured using overall, and recruitment site-specific recruitment rates collected monthly over the 24-month recruitment period