Open prostatectomy versus laparoscopic prostatectomy versus robot-assisted prostatectomy for organ-confined prostate cancer
| ISRCTN | ISRCTN59410552 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59410552 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | ICR-CTSU/2009/10021 |
| Sponsor | Imperial College London (UK) |
| Funder | Cancer Research UK (CRUK) (UK) (ref: CRUK/09/008) |
- 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
Plain English summary of protocol
http://www.cancerhelp.org.uk/trials/a-trial-comparing-three-operations-for-prostate-cancer
Contact information
Scientific
St Mary's Hospital
10th Floor QEQM Building
South Wharf Road
London
W2 1NY
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised feasibility study for a phase III randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(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). |
| Key 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. |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
W2 1NY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN59410552_BasicResults.pdf
- Basic results
Editorial Notes
25/10/2024: Basic results uploaded.
