Condition category
Cancer
Date applied
16/09/2020
Date assigned
18/09/2020
Last edited
08/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Prostate cancer is a form of cancer that develops in the prostate gland. Focal therapy involves treating just the cancer, while leaving the rest of the prostate and surrounding tissue intact. The aim of this study is to collect information about changes in men's sexual function after focal therapy to provide men with accurate information they can use when deciding which treatment to choose.

Who can participate?
Men who were treated for prostate cancer with irreversible electroporation (IRE) in the past 2 years can be enrolled in the retrospective arm of the study. Men who will be treated for prostate cancer with focal therapy with high-intensity focused ultrasound (HIFU), cryotherapy or IRE can take part in the prospective arm.

What does the study involve?
Men in the retrospective arm will be asked to fill in questionnaires about the quality of their erections and ejaculation. A telephone interview will be organised to collect more in-depth data about the changes in their sexual function after the treatment (covering topics such as erection, ejaculation, orgasm, changes in the size or shape of the penis, etc).
Men in the prospective arm will have an evaluation before surgery using the same questionnaires, and a first telephone interview to record their expectations. Another evaluation including questionnaires and a second telephone interview will be scheduled 3 months after surgery to collect more in-depth data about the changes in their sexual function after the treatment (covering topics such as erection, ejaculation, orgasm, changes in the size or shape of the penis, etc).

What are the possible benefits and risks of participating?
The researchers will try to accommodate patients' schedule to minimise the inconvenience in taking part in the interviews. Participants may worry about experiencing some discomfort discussing intimate matters with a researcher. The study team will make sure that the training of the interviewer and interview methods used allow men to feel at ease during the interview. Participants will receive compensation in the form of £40 vouchers and will help future patients benefit from more accurate information before treatment.

Where is the study run from?
University College London (UK)

When is the study starting and how long is it expected to run for?
April 2020 to February 2021

Who is funding the study?
Angiodynamics (USA)

Who is the main contact?
Gaelle Fiard
g.fiard@ucl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Gaelle Fiard

ORCID ID

http://orcid.org/0000-0003-3049-5318

Contact details

Division of Surgery and Interventional Science
University College London
3rd Floor
Charles Bell House
43-45 Foley Street
London
W1W 7TS
United Kingdom
+44 (0)7568764334
g.fiard@ucl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 278558

Study information

Scientific title

Sexual Assessment after Focal therapy with various Energy sources (SAFE): a mixed-methods study

Acronym

SAFE

Study hypothesis

Focal therapy has arisen as a promising tissue-preserving treatment option for men with localised prostate cancer, offering to better preserve men's genito-urinary function. However, most of the evaluation of function has taken place at a relatively high, non-granular level. However, most of the data used to provide informed consent for patients is obtained from retrospective – usually single-centre – series, or derived from prospective studies whose primary outcome was oncological. The aim of the SAFE study is to address this need by collecting in-depth details of men's sexual function after focal therapy with various energy sources, using qualitative research methods and validated questionnaires.

Ethics approval

Approved 02/09/2020, North West - Greater Manchester West Research Ethics Committee (Barlow House 3rd Floor, 4 Minshull Street, Manchester M1 3DZ, +44 (0)2071048285; gmwest.rec@hra.nhs.uk), REC ref: 20/NW/0335

Study design

Mixed-methods study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

See additional files

Condition

Localised prostate cancer treated with focal therapy

Intervention

1. Self-administered validated questionnaires
2. Semi-structured telephone interviews

Men in the retrospective arm will be asked to fill in validated questionnaires exploring and quantifying the quality of their erections and ejaculation. A telephone interview will be organised to collect more in-depth data about the evolution of their sexual function after the treatment (covering topics such as erection, ejaculation, orgasm, changes in the size or shape of the penis, etc).

Men in the prospective arm will have a baseline evaluation before surgery, using the same questionnaires, and a first telephone interview to record their expectations. Another evaluation including questionnaires and a second telephone interview will be scheduled 3 months after surgery to collect more in-depth data about the evolution of their sexual function after the treatment (covering topics such as erection, ejaculation, orgasm, changes in the size or shape of the penis, etc).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Qualitative sexual outcomes gathered using semi-structured telephone interviews at 3 months after focal therapy (prospective cohort)

Secondary outcome measures

1. Preoperative patients' expectations assessed using semi-structured telephone interviews at baseline (or before treatment)
2. Qualitative sexual outcomes gathered using semi-structured telephone interviews at various time points ranging from 6 months and 24 months after surgery (retrospective arm - the researchers will select patients to cover as many timepoints as possible but don’t know yet which ones precisely)
3. Erectile function measured by IIEF-15 at baseline and 3 months
4. Ejaculatory function measured by MSHQ-EjD-SF at baseline and 3 months

Overall trial start date

03/04/2020

Overall trial end date

28/02/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Retrospective cohort:
1. Men treated with focal IRE in the last 24 months agreeing to be approached after receiving the invitation letter
2. Preoperative normal sexual function (retrospective)
3. Signed informed consent by the patient

Prospective cohort:
1. Men with a histological diagnosis of prostate cancer on trans-rectal or transperineal template prostate biopsies
2. Gleason score ≤7
3. Clinical stage ≤T2cNoMo (radiological T3a allowed)
4. Serum PSA ≤15ng/ml
5. Local staging imaging as per guidelines to demonstrate localised disease (this may include MRI, CT, bonescan or functional imaging)
6. MRI-visible unilateral or anterior disease accessible to focal HIFU, cryotherapy or IRE
7. Baseline potency with erections sufficient for penetration
8. Signed informed consent by the patient

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

50

Participant exclusion criteria

Retrospective cohort:
1. Men with preoperative (remembered) altered sexual function or no sexual activity
2. Salvage treatment
3. Non-English readers and speakers
4. Vulnerable men unable to provide informed consent

Prospective cohort:
1. Men with baseline erectile dysfunction and erections insufficient for penetration
2. Men who had prostate surgery for cancer control e.g., radical prostatectomy, HIFU, cryosurgery, photodynamic therapy
3. Men undergoing whole-gland treatment
4. Non-English readers and speakers
5. Vulnerable men unable to provide informed consent

Recruitment start date

25/09/2020

Recruitment end date

30/11/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospitals NHS Foundation Trust
250 Euston Road
London
NW1 2PG
United Kingdom

Trial participating centre

London Urology Specialists
Emmanuel Kaye House 37 Devonshire Street
London
W1G 6QA
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
UCL Gower Street
London
WC1E 6BT
United Kingdom
+44 (0)203 447 5696
UCLH.randd@nhs.net

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Industry

Funder name

AngioDynamics

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. The protocol will be submitted for publication shortly.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Gaelle Fiard (g.fiard@ucl.ac.uk). Anonymised data can be made available and patients will be consenting to it. Anonymised scores on validated questionnaires and transcripts can be obtained for verification purposes.

Intention to publish date

28/02/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

08/10/2020: Uploaded protocol Version 1.0, 29 June 2020 (not peer reviewed). The participant information sheets have been uploaded. 17/09/2020: Trial's existence confirmed by North West - Greater Manchester West Research Ethics Committee.