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
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
Additional files
- ISRCTN11634296_PROTOCOL_V1.0_29June20.pdf Uploaded 08/10/2020
- ISRCTN11634296_PIS_retrospective_V2.0_28Aug20.docx Uploaded 08/10/2020
- ISRCTN11634296_PIS_prospective_V2.0_28Aug20.docx.docx Uploaded 08/10/2020