LopeRA

Disease site: Urological

Treatment Modality: Surgery

Status: Open to recruitment

LopeRA is a randomised controlled trial of laparoscopic, open and robot assisted prostatectomy as treatment for organ-confined prostate cancer. It is currently a feasibility study.

The primary endpoint is the success of recruitment and randomisation. The aim is to recruit 75 patients in a 12 month period (e.g. between the 12th and 24th month after all centres have been open to recruitment). In total it is planned that more than 100 patients will be recruited to the trial. Secondary endpoints include clinical and patient-orientated outcomes and compliance.

Patients with organ-confined prostate cancer become eligible for the trial once they have decided on surgical treatment. All recruited patients will be randomly assigned to receive either open, laparoscopic or robot assisted radical prostatectomy.

Ultimately, results from a phase III study will provide evidence as to whether the proposed advantages of minimally invasive techniques translate into improved oncological, clinical and quality of life outcomes. In addition, results will provide evidence to support cost effectiveness of each approach.