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 volunteersQualifiers
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
Other
Prospective
Treatments tested in this trial
Robotic Radical Prostatectomy
Procedure/SurgeryBilateral nerve spare radical prostatectomy
Penile doppler ultrasound
Diagnostic testStimulated PDUS to assess erectile machinery after ertogenic intracavernosal injection before and after robotic radical prostatectomy
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
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