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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.
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LOPERA
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Randomised controlled trial of laparoscopic, open and robot assisted prostatectomy as treatment for organ-confined prostate cancer.
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Topic
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Cancer (co-adopted by Generic Relevance & Cross Cutting Themes)
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Portfolio Eligibility
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Automatically eligible
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ISRCTN
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59410552
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EudraCT
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MREC N°
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09/H0704/70
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UKCRN ID
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6766
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WHO ID
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Research Summary
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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.
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Study Type
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Interventional
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Design Type
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Treatment
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Disease(s)
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Prostate
Surgery
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Phase
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Pilot/Feasibility
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Current Status
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Open
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Closure Date
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5/31/2014
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Global Sample Size
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100
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Global Recruitment to Date
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 30% |
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Geographical Scope
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UK Multi-Centre
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Lead Country
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England
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Open to new sites
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No
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Main Inclusion Criteria
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*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
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Main Exclusion Criteria
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*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
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Chief Investigator(s)
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| Prof Ara Darzi |
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Further details, please contact
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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
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| Funder(s) |
CTAAC
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| Sponsor(s) |
Imperial College London
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