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11 February 2012
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| [ Print-friendly version ] |
| Open prostatectomy versus laparoscopic prostatectomy versus robot-assisted prostatectomy for organ-confined prostate cancer |
| ISRCTN | ISRCTN59410552 |
| ClinicalTrials.gov identifier | |
| Public title | Open prostatectomy versus laparoscopic prostatectomy versus robot-assisted prostatectomy for organ-confined prostate cancer |
| Scientific title | Randomised controlled trial of laparoscopic, open and robot assisted prostatectomy as treatment for organ-confined prostate cancer |
| Acronym | LopeRA |
| Serial number at source | ICR-CTSU/2009/10021 |
| Study hypothesis | This study will demonstrate the feasibility of patient recruitment to a randomised controlled trial comparing open, laparoscopic and robot-assisted radical prostatectomy. |
| Lay summary | http://www.cancerhelp.org.uk/trials/a-trial-comparing-three-operations-for-prostate-cancer |
| Ethics approval | East London City Research Ethics Committee (REC) on 23/12/2009 (ref: 09/H0704/70) |
| Study design | Multicentre randomised feasibility study for a phase III randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Prostate cancer |
| Participants - inclusion criteria |
1. Prostate cancer patient that has chosen radical prostatectomy as treatment (with or without lymphadenectomy)
2. Clinical stage T1, T2a, T2b or T2c, N0 M0 3. Gleason score less than or equal to 7 4. Prostate specific antigen (PSA) less than or equal to 20 5. Aged greater than or equal to 18 years, male 6. Written informed consent |
| Participants - exclusion criteria |
1. Patient medically unfit for surgery
2. Prior pelvic radiotherapy or rectal excisional surgery 3. Positive bone scan or evidence of nodal metastases on magnetic resonance imaging (MRI) or computed tomography (CT) 4. Clinical stage T3 5. Neoadjuvant hormone therapy |
| Anticipated start date | 01/10/2009 |
| Anticipated end date | 30/09/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions |
There are three groups:
1. Open prostatectomy 2. Laparoscopic prostatectomy 3. Robot-assisted prostatectomy |
| Primary outcome measure(s) | Accrual rate: Aim to recruit more than 100 patients with at least 75 patients within a 12 month period (e.g. between 12 and 24 months after all centres are open to recruitment). |
| Secondary outcome measure(s) |
1. Compliance with protocol: a compliant patient will be defined as one who receives their allocated treatment and the in-patient standardised peri-operative care. We aim to show that more than 80% are compliant.
2. Clinical and patient-orientated outcomes: 2.1. Operation duration 2.2. Blood loss 2.3. Transfusion rates 2.4. Peri-operative haemoglobin change 2.5. Operative complications 2.6. Length of hospital stay 2.7. Pathological specimen positive margin rates and biochemical progression-free rates 2.8. Sexual function 2.9. Urinary continence 2.10. Quality of life measures All patients are followed up for 12 months. |
| Sources of funding | Cancer Research UK (CRUK) (UK) (ref: CRUK/09/008) |
| Trial website | |
| Publications | |
| Contact name | Prof Ara Darzi |
| Address |
St Mary's Hospital
10th Floor QEQM Building South Wharf Road |
| City/town | London |
| Zip/Postcode | W2 1NY |
| Country | United Kingdom |
| Sponsor | Imperial College London (UK) |
| Address |
G02, Sir Alexander Fleming Building
South Kensington Campus |
| City/town | London |
| Zip/Postcode | SW7 2AZ |
| Country | United Kingdom |
| Sponsor website: | http://www3.imperial.ac.uk/ |
| Date applied | 20/10/2009 |
| Last edited | 20/09/2011 |
| Date ISRCTN assigned | 12/01/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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