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

NCT07597798 | Recruiting DMC

• 2 other identifiers: EDGE number: 177704NHS Health Research Authority
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Radical Prostatectomy; Erectile Dysfunction Due to Arterial Insufficiency; Erectile Dysfunction Following Radical Prostatectomy; Robotic Radical Prostatectomy

Keywords

ED post RARP; Prostate Cancer Survivorship; Erectile dysfunction; Radical prostatectomy; Accessory pudendal artery; APA

Outcome Measures

Primary Outcomes (3)

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

Secondary Outcomes (2)

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

  12 months

• Percentage of Cases With Determinable APA Preservation Status on Video Review

  12 months

Study Arms (1)

Patients undergoing radical prostatectomy

Patients with good baseline erectile function undergoing bilateral nerve spare radical prostatectomy for localised prostate cancer.

Procedure: Robotic Radical Prostatectomy; Diagnostic Test: Penile doppler ultrasound

Interventions

Robotic Radical Prostatectomy PROCEDURE

Bilateral nerve spare radical prostatectomy

Patients undergoing radical prostatectomy

Penile doppler ultrasound DIAGNOSTIC_TEST

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

Patients undergoing radical prostatectomy

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospitals NHS foundation trust

London, W1G 8PH, United Kingdom

RECRUITING

Related Publications (3)

• Henry BM, Pekala PA, Vikse J, Sanna B, Skinningsrud B, Saganiak K, Walocha JA, Tomaszewski KA. Variations in the Arterial Blood Supply to the Penis and the Accessory Pudendal Artery: A Meta-Analysis and Review of Implications in Radical Prostatectomy. J Urol. 2017 Aug;198(2):345-353. doi: 10.1016/j.juro.2017.01.080. Epub 2017 Feb 12.

  PMID: 28202357 BACKGROUND

• Mulhall JP, Secin FP, Guillonneau B. Artery sparing radical prostatectomy--myth or reality? J Urol. 2008 Mar;179(3):827-31. doi: 10.1016/j.juro.2007.10.021. Epub 2008 Jan 25.

  PMID: 18221962 BACKGROUND

• Al-Mitwalli A, Tarim K, Wani M, Dickinson L, Lee WG, Ralph D, Tandogdu Z. Prostatic and pelvic imaging parameters to predict post radical prostatectomy erectile function recovery: a systematic review. Int J Impot Res. 2026 Jan;38(1):1-10. doi: 10.1038/s41443-025-01047-0. Epub 2025 May 2.

  PMID: 40316775 RESULT

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: May 19, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: May 19, 2026

Record last verified: 2025-12

Locations

GB (1)