EVERiST: Impact of Image Detected Accessory Pudendal Artery on Erection Recovery After Nerve Sparing Prostatectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-79
SponsorUniversity College, London

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients with localised prostate cancer undergoing radical prostatectomy with bilateral nerve sparing.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Robotic Radical Prostatectomy

    Procedure/Surgery

    Bilateral nerve spare radical prostatectomy

  • Penile doppler ultrasound

    Diagnostic test

    Stimulated PDUS to assess erectile machinery after ertogenic intracavernosal injection before and after robotic radical prostatectomy

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Patients undergoing radical prostatectomy2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants Enrolled During the Recruitment Period

Number of eligible participants who provide informed consent and are enrolled in the study during the 12-month recruitment period.

Time frame
12 months
2

Percentage of Participants Completing Follow-up Through 12 Months

Percentage of enrolled participants who complete all scheduled post-operative follow-up assessments up to 12 months after surgery.

Time frame
12 months
3

Percentage of Participants With Accessory Pudendal Artery Identified on Pre-operative mpMRI

Percentage of participants in whom an accessory pudendal artery (APA) is identified and mapped on pre-operative multiparametric MRI imaging.

Time frame
12 months

Secondary outcomes

1

Percentage of Participants With Complete Intraoperative Video Recording Available for APA Assessment

Percentage of participants with intraoperative surgical video recordings of sufficient quality to allow evaluation of accessory pudendal artery preservation.

Time frame
12 months
2

Percentage of Cases With Determinable APA Preservation Status on Video Review

Percentage of recorded surgeries in which accessory pudendal artery preservation status (preserved vs not preserved) can be determined by intraoperative video analysis.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.