Sexual Assessment after Focal Energy treatment/SAFE study V1.0
Research type
Research Study
Full title
Sexual Assessment after Focal therapy with various Energy sources: a mixed methods study
IRAS ID
278558
Contact name
Gaelle Fiard
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2020/02/48 , UCL Data Protection Registration number
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
Focal therapy, by sparing prostate tissue and neurovascular bundles, intends to treat prostate cancer with reduced treatment-related sexual side effects. The evaluation of sexual function should therefore be of the utmost importance when evaluating the results of focal therapy. Still, most data available were analysed retrospectively or obtained from prospective studies whose primary outcome was oncological. Studies often focused on erectile function, while components such as orgasmic and ejaculatory function were often under-reported. Other aspects such as morphometric penile modifications have been studied among patients treated by high-intensity focused ultrasound and cryotherapy, but fewer data are available regarding more recent energies such as irreversible electroporation (IRE). A decrease in sexual function was often noted at 3 months without supporting anatomical explanation, warranting further exploration.
Using mixed research methods, the SAFE study aims at eliciting detailed sexual outcomes after focal therapy, focusing on the early postoperative status. The study will comprise two cohorts: a retrospective cohort of patients treated with focal irreversible electroporation, and a prospective cohort of patients treated with 3 focal therapy modalities (HIFU, cryotherapy, IRE).
Patients will be recruited from 2 sites (NHS UCLH and London Urology Associates), eligible patients will be sexually-active patients treated by IRE in the last 24 months (retrospective cohort), or patients candidate to focal therapy with HIFU, cryotherapy or IRE (prospective cohort).
Semi-structured telephone interviews will be conducted, recorded, transcribed and analysed to offer in-depth insight on patients' expectations and detailed patient experiences of post-operative sexual outcomes.
The study is set to last for 6 months. A financial compensation (voucher) will be offered to participants.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
20/NW/0335
Date of REC Opinion
2 Sep 2020
REC opinion
Further Information Favourable Opinion