Condition category
Cancer
Date applied
29/04/2015
Date assigned
29/04/2015
Last edited
09/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Mr Veeru Kasivisvanathan

ORCID ID

Contact details

Royal Free Hampstead NHS Trust
Department of Oncology
Pond Street
London
NW3 2QG
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18902

Study information

Scientific title

PRostate Evaluation for Clinically Important disease: Sampling using Image-guidance Or Not?

Acronym

PRECISION

Study hypothesis

1. The proportion of men with clinically significant cancer detected by multi-parametric MRI-targeted biopsy (MRI-TB) will be no less than that detected by standard 12-core TRUS biopsy
2. The proportion of men with clinically insignificant cancer detected by multi-parametric MRI-targeted biopsy (MRI-TB) will be less than that detected by standard 12-core TRUS biopsy

Ethics approval

National Research Ethics Service Committee East Midlands - Leicester, ref: 15/EM/0188

Study design

Randomised; Interventional; Design type: Diagnosis

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 to request a participant information sheet

Condition

Topic: Cancer, Renal disorders; Subtopic: Prostate Cancer, Renal disorders; Disease: Prostate, All Renal disorders

Intervention

Arm 1 - 12-core transrectal prostate biopsy
Men undergo standard 12-core transrectal prostate biopsy. A trans-rectal ultrasound probe is used to visualise prostate anatomy and 12 prostate samples are taken. This may be done under local anaesthetic.

Arm 2 - MRI arm.
Men undergo a multi-parametric MRI. If there is a suspicious area then these men undergo MRI-targeted prostate biopsy. Up to three suspicious areas are targeted with up to 4 cores to each suspicious area. Software assisted registration may be used. A trans-rectal ultrasound probe is used to visualise prostate anatomy and the prostate samples are taken. This may be done under local anaesthetic. Men with an MRI without any suspicious areas do not undergo biopsy.

Men in each arm are followed up routinely for 30-days post intervention.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Proportion of men with clinically significant cancer detected

Secondary outcome measures

1. Proportion of men with clinically insignificant cancer detected
2. Proportion of men in MPMRI arm who avoid biopsy
3. Proportion of men in whom MPMRI score for suspicion of clinically significant cancer was 3, 4 or 5 but no clinically significant cancer was detected
4. Proportion of men who go on to definitive local treatment (e.g. radical prostatectomy, radiotherapy, brachytherapy) or systemic treatment (e.g. hormone therapy, chemotherapy)
5. Cancer core length of the most involved biopsy core (maximum cancer core length, MCCL)
6. Proportion of men with post-biopsy adverse events
7. Health related quality of life
8. Proportion Gleason grade upgrading in men undergoing radical prostatectomy
9. Cost per diagnosis of cancer

Overall trial start date

01/07/2015

Overall trial end date

01/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
2. Serum PSA ≤ 20ng/ml
3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer)
4. Fit to undergo all procedures listed in protocol
5. Able to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned Sample Size: 470; UK Sample Size: 150

Participant exclusion criteria

1. Prior prostate biopsy
2. Prior treatment for prostate cancer
3. Contraindication to MRI
4. Contraindication to prostate biopsy
5. Men in whom artifact would reduce the quality of the MRI
6. Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
7. Unfit to undergo any procedures listed in protocol

Recruitment start date

01/07/2015

Recruitment end date

01/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Erasmus University Medical Centre
-
Netherlands

Trial participating centre

Helsinki University Hospital
-
Finland

Trial participating centre

Ghent University Hospital
-
Belgium

Trial participating centre

Jewish General Hospital
-
Canada

Trial participating centre

North West London Hospitals NHS Trust
HA1 3UJ
United Kingdom

Trial participating centre

Radboud University
Nijmegen Medical Centre
-
Netherlands

Trial participating centre

Royal Free London NHS Foundation Trust
NW3 2QG
United Kingdom

Trial participating centre

Sapienza University of Rome
-
Italy

Trial participating centre

University Lille Nord de France
-
France

Trial participating centre

University College London Hospital (lead site)
NW1 2BU
United Kingdom

Sponsor information

Organisation

UCL Clinical Trials Unit

Sponsor details

Rockefeller Office Room 233
Rockefeller Building
21 University Street
London
WC13 6DE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/06/2016: Link to Cancer Help UK lay summary added.