NCT07597798 EVERiST: Impact of Image Detected Accessory Pudendal Artery on Erection Recovery After Nerve Sparing Prostatectomy
| NCT ID | NCT07597798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Radical Prostatectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2027-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2026-01-15 with a primary completion date of 2027-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prostate cancer is the most common cancer amongst men in the United Kingdom, and two common curative treatments are surgery to remove the prostate (radical prostatectomy) or radiotherapy. Both treatments can affect quality of life, mainly because of problems with erections and urinary leakage. Many men feel disappointed or regret their treatment choice because of changes in their sexual function. Surgeons often use a 'nerve-sparing' technique to reduce the risk of erectile dysfunction (ED), but many men still experience erection problems afterwards. A way to improve erectile function recovery after surgery further would be to identify accessory (additional) arteries to the penis. Up to one in three men have an extra artery called the accessory pudendal artery (APA). Preserving this artery during surgery may improve recovery of erections by protecting blood flow and reducing the risk or severity of ED. Until recently, surgeons could only try to see these arteries during the operation, and no study has tested whether they are preserved or whether this makes a difference. This has changed with the advent of imaging. Men already have an advanced MRI scan (called a multiparametric MRI) before prostate cancer treatment. These scans can also show whether an APA is present. In addition, robotic surgery, now the gold standard for radical prostatectomy, allows operations to be video recorded. This allows comparison of what was seen on the scan with what happened during surgery and then monitoring of recovery afterwards. Early research suggests that men with an APA have better erections before surgery. This study will test whether preserving the APA during surgery helps erections recover afterwards. In this first phase of the research (Phase 1), a feasibility study will be carried out at University College London Hospital. The study will invite 20-40 men with good sexual function before surgery, who are having robotic prostatectomy with a nerve-sparing approach. Multiparametric MRI scans will be used to identify whether an APA is present and video recordings will be collected to see if the artery was preserved. Participants will complete simple questionnaires on erections and quality of life before and after surgery up to 1 year. To assess whether the artery was preserved, an extra MRI scan will be organised after surgery for those with an APA, as well as penile ultrasound to assess erectile machinery. Ethical approval has already been obtained from the regulatory bodies, and the study is ready to start recruiting participants. The results will allow planning of a larger, national study (Phase 2). That study will test whether preserving the APA improves erectile recovery, reduces the severity of ED, and improves quality of life. If confirmed, this research could lead to modification in surgical approach, more personalised counselling before surgery, and reduced long-term need for costly ED treatments within the NHS.
Eligibility Criteria
Inclusion Criteria: * Men diagnosed with cT2-T3a N0 M0 PCa aged between 18 and 79 from all ethnic backgrounds. * Patients who underwent a prostate mpMRI before prostate biopsy. * Medically fit to undergo RARP. * Diagnostic quality prostate biopsies concordant with a diagnostic quality prostate mpMRI adequate to provide a surgical plan. * Scheduled for RARP with a recommendation of NVB spare based on multidisciplinary meetings informed by mpMRI, biopsy result and clinical factors. * Sexually active men with no to mild ED at baseline based on IIEF-EFD (\>=24) questionnaire. * Preference to preserve erectile function for sexual intercourse. * Ability to read English sufficiently to understand PIS and able to give informed consent. Exclusion Criteria: * Established moderate/ severe ED (IIEF-EFD \<24) * Patients who received neo-adjuvant androgen deprivation therapy. * Patients with previous surgery for benign prostatic enlargement * Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy. * Previous pelvic or penile fracture * Previous surgery for ED * Poor quality prostate mpMRI or biparametric MRI (no contrast) * Established vascular disease (ischaemic heart disease, cerebrovascular disease, peripheral vascular disease)
Frequently Asked Questions
Who can join the NCT07597798 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 79 Years, studying Radical Prostatectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07597798 currently recruiting?
Yes, NCT07597798 is actively recruiting participants. Visit ClinicalTrials.gov or contact University College, London to inquire about joining.
Where is the NCT07597798 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07597798 clinical trial?
NCT07597798 is sponsored by University College, London. The trial plans to enroll 40 participants.