Assessing the sexual consequences of focal therapy for localised prostate cancer

Not Applicable

• Conditions: ocalised prostate cancer treated with focal therapy; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN11634296
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-18
• Last Update Posted: 29 November 2021
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: Stopped
• Sex: Male
• Target Recruitment: 50

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 1. Preoperative patients' expectations assessed using semi-structured telephone interviews at baseline (or before treatment)<br> 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)<br> 3. Erectile function measured by IIEF-15 at baseline and 3 months<br> 4. Ejaculatory function measured by MSHQ-EjD-SF at baseline and 3 months<br>