Title: Videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in patients with penile cancer: a feasibility randomised controlled trial
Funder: Department of Health and Social Care

Abstract: Research question Is it feasible to perform a randomised controlled trial (RCT) comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men with penile or urethral cancer requiring inguinal lymphadenectomy, and determine the design of such an RCT. Background Penile cancer is one of the rare types of male cancer. Overall, there were about 637 cases of penile cancers in the UK in 2015 and there were approximately 134 deaths in 2016. However, the incidence of penile cancer in Western countries is increasing. In the UK, penile cancer services are centralised such that only 12 specialist centres are involved in the management of penile cancer patients. The main treatments of penile cancer in men with invasive penile cancer is primarily surgical resection of the tumour. Lymph node involvement is one of the most important prognostic indicators in penile cancer. Radical inguinal lymphadenectomy is the main treatment option for manging metastatic inguinal lymph node involvement. Radical inguinal lymphadenectomy can be performed by an open approach (current standard of care) or by using a videoendoscopic approach. There is currently significant uncertainty as to which is the better method for performing radical inguinal lymphadenectomy. Aims and objectives The aim of this proposal is to assess the feasibility of performing a RCT comparing videoendoscopic radical inguinal lymphadenectomy versus open radical inguinal lymphadenectomy in men diagnosed with penile or urethral cancer requiring inguinal lymphadenectomy, and determine the design of such an RCT. Methods We plan to perform a feasibility randomised controlled trial that will recruit 50 people with penile cancer requiring radical inguinal lymphadenectomy and randomise them to videoendoscopic radical inguinal lymphadenectomy (25 participants) versus open radical inguinal lymphadenectomy (25 participants). We will assess the acceptability of the trial to patients and clinicians. We will also assess a number of outcomes including oncological clearance, complications, and health-related quality of life until 6 months. Timelines for delivery The study is scheduled to take 36 months in total: Pre-award: ethical and regulatory approval 4 months prior to recruitment will be used for site set-up 23 months for recruitment 6 months after recruitment for completion of follow up data collection 3 months after all follow up data has been collected for data analysis (including advisory group meetings for design of subsequent definitive study). 6. Anticipated impact and dissemination The findings of this study and the subsequent definitive trial will have implications for the management of men with penile or urethral cancer in the UK and globally. The trial will be registered in ClinicalTrials.gov and the protocol will be made available publicly. Data from the trial will be presented at National and International meetings and published in a journal. The findings will be also be disseminated through the European Reference Network which covers Rare Urogenital conditions (eUROGEN) and through the British Association of Urological Surgeons (BAUS). Further dissemination of trial results will be to charitable organisations and patient groups including dissemination via social media.

Lay abstract: Cancers of penis and urethra (outlet for passing urine)are rare male genital cancers (600 new cases and 134 deaths annually in UK). As part of the treatment, patients may require an operation called radical inguinal lymphadenectomy , a procedure to remove groin lymph nodes. This is a major surgical procedure and is usually performed as an open operation: 20% to 60% of patients develop complications, some of which lead to long-standing pain and disfigurement. Video endoscopic inguinal lymphadenectomy (VEIL) is a relatively new minimally invasive procedure in which the groin lymph nodes are removed using key hole surgery. VEIL may have fewer overall complications than open surgery, although some complications may be more common such as lymphoecoele (collection of lymph under the skin). This can sometimes cause pain and require additional treatments. Furthermore, there is uncertainty about whether the reduction in complications in VEIL is because of careful selection of patients and whether the cancer recurrence is similar in VEIL as in open surgery. This uncertainty can only be resolved through a well-designed randomised controlled trial (RCT), a type of study which ensures that similar types of patient receive VEIL and open surgery. A previous RCT in USA comparing the two procedures for mainly skin cancers could not recruit sufficient people because of patient preference for VEIL. The method of presenting the trial to participants and participants understanding of the trial could be one of the major reasons for poor recruitment despite the uncertainty about long-term cancer recurrence. There are no other published or ongoing RCTs comparing VEIL versus open surgery. The aim of this research is to find out whether it is possible to conduct a RCT to compare VEIL versus open inguinal lymphadenectomy in patients diagnosed with penile cancer. Fifty patients will take part in this study and will be followed up for 6 months. Half will undergo VEIL while the other half will undergo open surgery. Participants in each group will be chosen by the study. This study will look at whether this type of study is acceptable to patients and clinicians and will help design a larger trial ( definitive RCT ) to find out if VEIL or open surgery is better for patients and NHS. A patient representative was involved in the preparation of this grant proposal. This patient representative and additional patient representatives will be involved in the management and steering committees, advisory group meetings for designing the definitive RCT, writing the participant information sheet and plain language report, and in dissemination. Additional patients will be involved in the qualitative research that will look at the acceptability of the two treatments. Dissemination will be via patient groups, social media, presentations at conferences, and publications in medical journals.

Research activity codes: 6.4 SURGERY
Health categories: CANCER AND NEOPLASMS