Randomised controlled trial of laparoscopic, open and robot assisted prostatectomy as treatment for organ-confined prostate cancer (LOPERA).
Disease site: Urological Prostate cancer
Treatment modality: Surgery
Status: In active follow-up
LopeRA 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.
Chief Investigator: Professor the Lord Ara Darzi, Imperial College, London
ICR-CTSU Scientific Lead: Dr Emma Hall
Trial management contact: Deborah Piercy - Trial Manager, [email protected]
Sponsor: Imperial College London
Funding: Cancer Research UK (CRUK/09/008)
Further information on the LopeRA trial may be found on the following sites:
Monthly accrual figures are available from the UK Clinical Trials Gateway
Patient friendly information on the LopeRA trial at CancerHelp UK
Publications and presentations
Mayer E, Piercy D, Kerr K, Lewis R, Griffin C, Cohen D, Corbishley C, Vale J, Hall E, Darzi A. November, ed. Randomised controlled trial (RCT) of Laparascopic, OPEn and robot- assisted prostatectomy as treatment for organ-confined prostate cancer. LopeRA feasibility study. NCRI National Cancer Conference; 2011; Liverpool.
Mayer EK, Piercy D, Cohen DC, Kerr K, Lewis R, Corbishley C, Hall E, Vale JA, Darzi A, and on behalf of the LOPERA Trial Management Group. Randomised controlled trial of laparoscopic open and robot assisted prostatectomy as treatment for organ-confined prostate cancer. The Hamlyn Symposium on Medical Robotics; 2010; London. Imperial College.