By Nigel Hacking
The National Institute of Health and Care Excellence (NICE) guidelines, published in 2013, stated that current evidence on the safety and efficacy of prostate artery embolization was inadequate in quantity and quality and so it should only be used in the context of research. They went on to state that a multidisciplinary team including urologists and interventional radiologists should be involved, and that randomised controlled trials or cohort studies including an appropriate registry would be encouraged.
The guidelines stated that such a registry should clearly document patient selection criteria; all complications, specifically sexual dysfunction, and efficacy outcomes and that it should include measures of urinary function, symptoms and quality of life.
The UK-ROPE is the first multidisciplinary registry in the UK to be funded jointly by NICE, the British Society of Interventional Radiology (BSIR) and the British Association of Urological Surgeons (BAUS).
NICE have appointed CEDAR, the Cardiff University Health Technology Research Centre to host the registry, prepare protocols and national ethics approvals. They will provide full statistical support and write the final report. This in turn will inform NICE when they review their guidance in 3–4 years.
This process is well underway and the registry is due to launch in May 2014.
Two cohorts will be compared. Whilst not a randomised controlled trial, these two cohorts will be matched for age, prostate size and symptoms as is practicable. Surgical treatments will include transurethral prostatectomy (TURP), holmium laser prostatectomy (HoLEP) and open prostatectomy. It is expected that 120–150 patients per cohort will be recruited in a 12-month period.
Data collection will be carried out online and analyses with reports will be available at various time points. It will be finally, available after a further 12-month follow-up, for all patients.
Data to be studied include International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF), three-day urinary diary as well as the prostate volume, flow rates, residual volumes and the enhancement pattern of the prostate after embolization. Prostatic cancer, neurogenic bladder and advanced atheroma limiting access to the internal iliac and prostatic arteries are exclusion criteria.
Length of stay, procedural factors such as the radiation dose after embolization and need for blood transfusion after prostatectomy will be collated. Complications including non-target embolization (after embolization) and retrograde ejaculation and incontinence (after prostatectomy) will be recorded and included in the final report.
Initial experience suggests that embolization will be most beneficial in the younger man with larger symptomatic prostates who would like to avoid, or at least delay, prostatectomy, if possible.
At this stage a randomised controlled trial against prostatectomy was felt to be premature. Clinical opinion is that prostate artery embolization undoubtedly holds promise and UK-ROPE has been designed to confirm this promise, but also to show which patients will benefit most as well as showing any resulting complications in a multicentre setting. This will allow more targeted questions to be tested in a randomised controlled trial over the next few years.
Funding to cover additional hospital costs in eight centres will be provided by a research grant donated by Cook Medical.
A further 8–10 centres have successfully bid for research grants, or have established local funding arrangements. All centres will have been appropriately trained and proctored prior to entering cases. Each centre will submit no less than 15 prostatic artery embolization cases.
Nigel Hacking is a consultant interventional radiologist at University Hospitals Southampton, UK. He is the chairman of the UK-ROPE Standing Committee. He has reported no disclosures pertaining to the article
