Plain English Summary
http://www.cancerhelp.org.uk/trials/a-trial-comparing-three-operations-for-prostate-cancer
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICR-CTSU/2009/10021
Study information
Scientific title
Randomised controlled trial of laparoscopic, open and robot assisted prostatectomy as treatment for organ-confined prostate cancer
Acronym
LopeRA
Study hypothesis
This study will demonstrate the feasibility of patient recruitment to a randomised controlled trial comparing open, laparoscopic and robot-assisted radical prostatectomy.
Ethics approval
East London City Research Ethics Committee (REC), 23/12/2009, ref: 09/H0704/70
Study design
Multicentre randomised feasibility study for a phase III randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Prostate cancer
Intervention
There are three groups:
1. Open prostatectomy
2. Laparoscopic prostatectomy
3. Robot-assisted prostatectomy
Intervention type
Other
Phase
Phase III
Drug names
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 trial start date
01/10/2009
Overall trial end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
100
Participant 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
Recruitment start date
01/10/2009
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Mary's Hospital
London
W2 1NY
United Kingdom
Sponsor information
Organisation
Imperial College London (UK)
Sponsor details
G02
Sir Alexander Fleming Building
South Kensington Campus
London
SW7 2AZ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: CRUK/09/008)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://ubimon.doc.ic.ac.uk/Hamlyn2014/public/Proceedings_2014.pdf