Actively Recruiting

Age: 18Years - 79Years
MALE
ID07597798

EVERiST: Erectile Function Recovery After Bilateral Neurovascular Bundle Sparing Robot-Assisted Radical Prostatectomy With or Without Accessory Pudendal Artery Detected by Multiparametric MRI: A Feasibility Study

Led by University College, London · Updated on 2026-05-19

40

Participants Needed

1

Research Sites

26 weeks

Total Duration

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AI-Summary

What this Trial Is About

Prostate cancer is the most common cancer among men in the UK, with treatments including surgery to remove the prostate or radiotherapy. Both can affect quality of life, mainly due to erectile dysfunction and urinary leakage. This study explores whether preserving an accessory pudendal artery (APA), an extra artery found in up to one in three men, during nerve-sparing robotic prostate surgery improves recovery of erectile function. The research focuses on men with good baseline sexual function undergoing robotic surgery at University College London Hospital. Participants will have preoperative multiparametric MRI scans to detect the presence of an APA and robotic surgery videos will be reviewed to see if the artery was preserved. Up to 40 men aged 18 to 79 with localized prostate cancer and good baseline erectile function will be included. Follow-up includes questionnaires on erectile function and quality of life at baseline, 6 weeks, 6 months, and 12 months after surgery. Additional imaging like a 3-month postoperative MRI and optional penile Doppler ultrasound will be performed for those with an APA. Participants will undergo regular assessments including patient-reported outcome measures and imaging tests to evaluate erectile function recovery. The study will also review surgical videos to assess preservation of the APA. The main outcomes include recruitment feasibility, follow-up completion, and identification of the APA on MRI scans. This feasibility study aims to inform a larger trial that could improve surgical approaches and patient counseling for prostate cancer treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 79Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men aged 18 to 79 years diagnosed with localized prostate cancer (cT2-T3a N0 M0)
  • Underwent multiparametric MRI of the prostate before biopsy
  • Medically fit for robotic-assisted radical prostatectomy (RARP)
  • Diagnostic quality prostate biopsies matching MRI findings for surgical planning
  • Scheduled for bilateral nerve-sparing RARP based on multidisciplinary team recommendation
  • Sexually active with no or mild erectile dysfunction (IIEF-EFD score 64)
  • Desire to preserve erectile function for sexual intercourse
  • Able to read English and give informed consent
Not Eligible

You will not qualify if you...

  • Moderate or severe erectile dysfunction (IIEF-EFD score <24)
  • Previous neo-adjuvant androgen deprivation therapy
  • Prior surgery for benign prostatic enlargement
  • Previous prostate cancer treatments (radiotherapy, brachytherapy, focal therapy, chemotherapy)
  • History of pelvic or penile fracture
  • Prior surgery for erectile dysfunction
  • Poor quality prostate MRI or biparametric MRI without contrast
  • Established vascular disease such as ischemic heart disease, cerebrovascular disease, or peripheral vascular disease

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for multiparametric MRI and eligibility assessment

Surgery

Duration - 1 day

Participants undergo bilateral nerve-sparing robotic-assisted radical prostatectomy to treat localized prostate cancer.

1 visit (in-person) for the surgical procedure

Post-operative Follow-up

Duration - 12 months

Participants are followed up to assess erectile function recovery and surgical outcomes using patient-reported outcome measures and optional diagnostic tests.

Visits at 6 weeks, 3 months (including optional mpMRI for some participants), 6 months, and 12 months post-surgery; optional penile Doppler ultrasounds before and after surgery

Trial Site Locations

Total: 1 location

1

University College London Hospitals NHS foundation trust

London, United Kingdom, W1G 8PH

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Variations in the Arterial Blood Supply to the Penis and the Accessory Pudendal Artery: A Meta-Analysis and Review of Implications in Radical Prostatectomy.

Brandon Michael Henry, Przemysław A Pękala, Jens Vikse...

https://pubmed.ncbi.nlm.nih.gov/28202357

Prostatic and pelvic imaging parameters to predict post radical prostatectomy erectile function recovery: a systematic review.

Abdullah Al-Mitwalli, Kayhan Tarim, Mudassir Wani...

https://pubmed.ncbi.nlm.nih.gov/40316775