Condition category
Cancer
Date applied
20/10/2009
Date assigned
12/01/2010
Last edited
15/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Ara Darzi

ORCID ID

Contact details

St Mary's Hospital
10th Floor QEQM Building
South Wharf Road
London
W2 1NY
United Kingdom

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 measures

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

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

http://www3.imperial.ac.uk/

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

Results - basic reporting

Publication summary

2014 results in: http://ubimon.doc.ic.ac.uk/Hamlyn2014/public/Proceedings_2014.pdf

Publication citations

Additional files

Editorial Notes