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NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions.
LOPERA

Randomised controlled trial of laparoscopic, open and robot assisted prostatectomy as treatment for organ-confined prostate cancer.

Specialty
Cancer (co-adopted by Surgery)
Portfolio Eligibility
Automatically eligible
ISRCTN 59410552
EudraCT
MREC N° 09/H0704/70
UKCRN ID 6766
WHO ID
Research Summary
LopeRA is a multi-centre randomised controlled trial, phase III feasibility study. Patients are randomised to laparoscopic versur open versus robot-assisted radical prostatectomy. The primary aim is to demonstrate feasibility of patient recruitment. Ultimately, results of 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 the cost effectiveness of each approach.
Study Type Interventional
Design Type Treatment
Disease(s) Prostate
Phase Pilot/Feasibility
Current Status Closed - in follow-up
Closure Date 6/13/2013
Global Sample Size 100
Global Recruitment to Date
  30%
Geographical Scope UK Multi-Centre
Lead Country England
Health care professionals can obtain a copy of the protocol by clicking here
Additional Information

If you are a patient or relative this link will take you to a description of the trial in plain English on CancerHelp UK.

Main Inclusion Criteria
*Prostate cancer patient that has chosen radical prostatectomy as treatment (with or without lymphadenectomy);
*Clinical stage T1, T2a, T2b or T2c, N0 M0;
*Gleason score ≤7;
*PSA ≤20;
*Aged ≥18 years;
*Written informed consent
Main Exclusion Criteria
*Patient medically unfit for surgery;
*Prior pelvic radiotherapy or rectal excisional surgery;
*Positive bone scan or evidence of nodal metastases on MRI or CT;
*Clinical stage T3;
* Neoadjuvant hormone therapy
Chief Investigator(s)
Prof Ara Darzi
Further details, please contact
Miss Deborah Piercy

The Institute for Cancer Research
ICR Clinical Trials & Statistics Unit (ICR-CTSU),
Section of Clinical Trials,
Sir Richard Doll Building
15 Cotswold Road
Sutton
SM2 5NG
UNITED KINGDOM

Tel: 020 8722 4057
Fax: 020 8770 7876
Deborah.Piercy@icr.ac.uk
Funder(s) CTAAC
Sponsor(s) Imperial College of Science, Technology and Medicine




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