Magnetic resonance imaging-targeted biopsy compared to standard trans-rectal ultrasound guided biopsy for the diagnosis of prostate cancer in men without prior biopsy

ISRCTN	ISRCTN18440098
DOI	https://doi.org/10.1186/ISRCTN18440098
ClinicalTrials.gov (NCT)	NCT02380027
Protocol serial number	18902
Sponsor	UCL Clinical Trials Unit
Funder	National Institute for Health Research

Submission date: 29/04/2015
Registration date: 29/04/2015
Last edited: 09/08/2019

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-using-mri-to-help-diagnose-prostate-cancer-precision

Contact information

Mr Veeru Kasivisvanathan
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Diagnosis
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	PRostate Evaluation for Clinically Important disease: Sampling using Image-guidance Or Not?
Study acronym	PRECISION
Study objectives	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(s)	National Research Ethics Service Committee East Midlands - Leicester, ref: 15/EM/0188
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Proportion of men with clinically significant cancer detected
Key secondary outcome measure(s)	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
Completion date	01/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Male
Target sample size at registration	150
Total final enrolment	500
Key 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
Key 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
Date of first enrolment	01/07/2015
Date of final enrolment	01/10/2017

Locations

Countries of recruitment

United Kingdom
England
Belgium
Canada
Finland
France
Italy
Netherlands

Study participating centres

Erasmus University Medical Centre

-
Netherlands

Helsinki University Hospital

-
Finland

Ghent University Hospital

-
Belgium

Jewish General Hospital

-
Canada

North West London Hospitals NHS Trust

HA1 3UJ
United Kingdom

Radboud University

Nijmegen Medical Centre
-
Netherlands

Royal Free London NHS Foundation Trust

NW3 2QG
United Kingdom

Sapienza University of Rome

-
Italy

University Lille Nord de France

-
France

University College London Hospital (lead site)

NW1 2BU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in repository
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	10/05/2018	09/08/2019	Yes	No
Protocol article	protocol	12/10/2017	09/08/2019	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

09/08/2019: The following changes were made to the trial record:
1. Publication references added.
2. The total final enrolment was added.
22/07/2019: ClinicalTrials.gov number added.
09/06/2016: Link to Cancer Help UK lay summary added.