Open prostatectomy versus laparoscopic prostatectomy versus robot-assisted prostatectomy for organ-confined prostate cancer
| ISRCTN | ISRCTN59410552 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59410552 |
| Secondary identifying numbers | ICR-CTSU/2009/10021 |
- Submission date
- 20/10/2009
- Registration date
- 12/01/2010
- Last edited
- 25/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.cancerhelp.org.uk/trials/a-trial-comparing-three-operations-for-prostate-cancer
Contact information
Prof Ara Darzi
Scientific
Scientific
St Mary's Hospital
10th Floor QEQM Building
South Wharf Road
London
W2 1NY
United Kingdom
Study information
| Study design | Multicentre randomised feasibility study for a phase III randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial of laparoscopic, open and robot assisted prostatectomy as treatment for organ-confined prostate cancer |
| Study acronym | LopeRA |
| Study objectives | This study will demonstrate the feasibility of patient recruitment to a randomised controlled trial comparing open, laparoscopic and robot-assisted radical prostatectomy. |
| Ethics approval(s) | East London City Research Ethics Committee (REC), 23/12/2009, ref: 09/H0704/70 |
| Health condition(s) or problem(s) studied | Prostate cancer |
| Intervention | There are three groups: 1. Open prostatectomy 2. Laparoscopic prostatectomy 3. Robot-assisted prostatectomy |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/10/2009 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Mary's Hospital
London
W2 1NY
United Kingdom
W2 1NY
United Kingdom
Sponsor information
Imperial College London (UK)
University/education
University/education
G02, Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: CRUK/09/008)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results | 12/07/2014 | No | No | |
| Basic results | 25/10/2024 | No | No |
Additional files
Editorial Notes
25/10/2024: Basic results uploaded.
