Assessing the sexual consequences of focal therapy for localised prostate cancer
| ISRCTN | ISRCTN11634296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11634296 |
| IRAS number | 278558 |
| Secondary identifying numbers | IRAS 278558 |
- Submission date
- 16/09/2020
- Registration date
- 18/09/2020
- Last edited
- 23/11/2021
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Cancer
Plain English summary of protocol
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 2022 (updated 17/05/2021, previously: August 2021)
Who is funding the study?
Angiodynamics (USA)
Who is the main contact?
Gaelle Fiard
g.fiard@ucl.ac.uk
Contact information
Scientific
Division of Surgery and Interventional Science
University College London
3rd Floor, Charles Bell House
43-45 Foley Street
London
W1W 7TS
United Kingdom
 ORCID ID |
0000-0003-3049-5318 |
|---|---|
| Phone | +44 (0)7568764334 |
| g.fiard@ucl.ac.uk |
Study information
| Study design | Mixed-methods study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | ISRCTN11634296_PIS_retrospective_V2.0_28Aug20.docx |
| Scientific title | Sexual Assessment after Focal therapy with various Energy sources (SAFE): a mixed-methods study |
| Study acronym | SAFE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 03/04/2020 |
| Completion date | 28/02/2022 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 25/09/2020 |
| Date of final enrolment | 30/11/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
NW1 2PG
United Kingdom
37 Devonshire Street
London
W1G 6QA
United Kingdom
Sponsor information
University/education
Joint Research Office
UCL Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 (0)203 447 5696 |
|---|---|
| UCLH.randd@nhs.net | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 28/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The protocol will be submitted for publication shortly. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2.0 | 28/08/2020 | 08/10/2020 | No | Yes |
| Participant information sheet | version V2.0 | 28/08/2020 | 08/10/2020 | No | Yes |
| Protocol file | version V1.0 | 29/06/2020 | 08/10/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No |
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
Editorial Notes
23/11/2021: The study was stopped due to the delay in the study set up because of Covid-19, and the fact that the CI had to move overseas.
17/05/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/05/2021 to 30/11/2021.
2. The overall end date was changed from 31/08/2021 to 28/02/2022.
3. The intention to publish date was changed from 31/08/2022 to 28/02/2023.
4. The plain English summary was updated to reflect these changes.
19/11/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2020 to 30/05/2021.
2. The overall trial end date was changed from 28/02/2021 to 31/08/2021.
3. The intention to publish date was changed from 28/02/2022 to 31/08/2022.
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.
