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

2026年5月13日 更新者:University College, London

EVERiST: Erectile Function Recovery After Bilateral neuroVascular Bundle Sparing Robot Assisted Radical prostatEctomy in Patients With or Without an Accessory Pudendal aRtery Detected on diagnoSTic Multiparametric MRI: A Feasibility Study

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.

調査の概要

詳細な説明

Prostate cancer is the most common cancer among men in the UK and the second leading cause of cancer-related deaths, with over 55,000 new cases diagnosed each year. It is a major health concern, but when caught early, localized prostate cancer can often be treated successfully. Treatments such as surgery (radical prostatectomy) or radiotherapy aim to cure the disease. Over the years, imaging techniques have advanced significantly. A specialized scan called multi-parametric MRI (mpMRI) is now routinely used to diagnose prostate cancer and to guide biopsies, allowing doctors to precisely target areas of concern.

Despite these advances, prostate cancer surgery, even with modern robotic-assisted techniques, can have long-lasting side effects. These include erectile dysfunction (ED) and urinary incontinence, both of which can have a significant impact on a patient's quality of life. In fact, poor sexual function is one of the most commonly reported problems after surgery, affecting many patients' mental and emotional wellbeing. Every year, around 8,000 men undergo radical prostatectomy in England through the NHS, and the majority experience some degree of these side effects.

Surgical techniques such as neurovascular bundle (NVB) sparing are designed to protect the nerves and blood vessels around the prostate that are critical for erectile function. However, recovery of erectile function after NVB-sparing surgery is unpredictable, and many patients do not regain their full sexual function. The reasons for this are not fully understood. Some experts believe that erectile dysfunction may be due to damage to blood vessels, while others suggest nerve damage is the primary cause. It's likely that both factors play a role.

One overlooked issue might be variations in pelvic anatomy. In up to 38% of men, the blood vessels that supply the penis-such as the accessory pudendal arteries (APAs)-can be in different locations than expected. These variations are often not considered during conventional nerve-sparing procedures, which focus on preserving structures behind the prostate. If these additional arteries are damaged or removed during surgery, it could contribute to erectile dysfunction.

Fortunately, new tools offer the potential to address this. High-resolution mpMRI scans, which are already part of the standard diagnostic process for prostate cancer, can map the location of these blood vessels before surgery. Additionally, robotic-assisted surgery allows surgeons to record the entire operation in detail. By analyzing these recordings alongside the pre-surgery MRI scans and post-surgery outcomes, researchers can better understand how preserving these arteries affects recovery of erectile function.

This is feasibility study aims to explore whether identifying and preserving accessory pudendal arteries during surgery can improve erectile function outcomes for prostate cancer patients. The goal is to assess whether it's feasible to incorporate these imaging and surgical techniques into regular practice. If successful, this research could guide surgeons in refining their methods, help patients make better-informed decisions, and ultimately improve recovery outcomes for men undergoing prostate cancer surgery.

This is a prospective, single-centre, non-interventional feasibility study evaluating functional and imaging outcomes in patients with localized prostate cancer undergoing bilateral neurovascular bundle (NVB)-sparing robotic-assisted radical prostatectomy (RARP) at University College London Hospitals.

The study will recruit 20-40 sexually active men, aged 18 years or older, with good baseline erectile function (IIEF-EF ≥24). All procedures will be performed by one of four designated surgeons (Mr Zafer Tandogdu, Mr Ben Lamb, Mr Ashwin Sridhar, Prof Greg Shaw) to minimise surgical variability.

Data collection: Demographics, medical history, and preoperative multi-parametric MRI (mpMRI) parameters will be recorded. Functional outcomes will be assessed using validated Patient-Reported Outcome Measures (PROMs) at baseline, 6 weeks, 6 months, and 12 months post-surgery. Standard UCLH andrology follow-up will continue, with optional telephone consultations instead of clinic visits.

Additional assessments:

  • 3-month follow-up mpMRI will be performed only in participants with an accessory pudendal artery (APA) identified on their baseline mpMRI, to assess vessel patency.
  • Penile Doppler ultrasound (optional) will be offered to participants considering intracavernosal injections for erectile dysfunction, both before and after surgery.

Surgical quality assessment: Intraoperative videos (routine recordings made for training) will capture only the operative field, excluding identifiable patient features. These anonymised recordings will be securely stored and reviewed by high-volume surgeons for assessment of surgical technique. Theatre staff consent procedures have been implemented to address GDPR and confidentiality.

Participation is entirely voluntary. The aim is to assess the feasibility of recruitment, data collection, and follow-up procedures to inform a larger future study.

The aim of this project is to assess the feasibility and acceptability of conducting a full-scale observational study that investigates whether imaging-detected accessory pudendal arteries (APAs) influence erectile function outcomes following nerve-sparing robot-assisted radical prostatectomy (RARP).

In other words, the main goal of this feasibility study is to test whether it is possible and practical to run a larger future study. The investigators will explore whether men can be successfully recruited and followed up, and whether imaging and surgical data can be collected and analysed in a reliable way. This will lay the groundwork for a definitive study on whether preserving APAs affects erectile recovery after prostate surgery.

研究の種類

観察的

入学 (推定)

40

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • London、イギリス、W1G 8PH
        • 募集
        • University College London Hospitals NHS Foundation Trust
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Zafer Tandogdu, PhD, MD, FRCS

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Patients undergoing radical prostatectomy
Patients with good baseline erectile function undergoing bilateral nerve spare radical prostatectomy for localised prostate cancer.
Bilateral nerve spare radical prostatectomy
Stimulated PDUS to assess erectile machinery after ertogenic intracavernosal injection before and after robotic radical prostatectomy

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants Enrolled During the Recruitment Period
時間枠:12 months
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
時間枠: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
時間枠:12 months
Percentage of participants in whom an accessory pudendal artery (APA) is identified and mapped on pre-operative multiparametric MRI imaging.
12 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants With Complete Intraoperative Video Recording Available for APA Assessment
時間枠:12 months
Percentage of participants with intraoperative surgical video recordings of sufficient quality to allow evaluation of accessory pudendal artery preservation.
12 months
Percentage of Cases With Determinable APA Preservation Status on Video Review
時間枠:12 months
Percentage of recorded surgeries in which accessory pudendal artery preservation status (preserved vs not preserved) can be determined by intraoperative video analysis.
12 months

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月15日

一次修了 (推定)

2027年7月15日

研究の完了 (推定)

2028年1月15日

試験登録日

最初に提出

2025年12月25日

QC基準を満たした最初の提出物

2026年5月13日

最初の投稿 (実際)

2026年5月19日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月19日

QC基準を満たした最後の更新が送信されました

2026年5月13日

最終確認日

2025年12月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • EDGE number: 177704
  • NHS Health Research Authority (その他の識別子:IRAS number: 335003)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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