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 number | NCT02380027 |
| Secondary identifying numbers | 18902 |
- 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
Contact information
Mr Veeru Kasivisvanathan
Scientific
Scientific
Royal Free Hampstead NHS Trust
Department of Oncology
Pond Street
London
NW3 2QG
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Diagnosis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a 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 | 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 study start date | 01/07/2015 |
| Completion date | 01/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Planned Sample Size: 470; UK Sample Size: 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
- Belgium
- Canada
- England
- Finland
- France
- Italy
- Netherlands
- United Kingdom
Study participating centres
Erasmus University Medical Centre
-
Netherlands
Netherlands
Helsinki University Hospital
-
Finland
Finland
Ghent University Hospital
-
Belgium
Belgium
Jewish General Hospital
-
Canada
Canada
North West London Hospitals NHS Trust
HA1 3UJ
United Kingdom
United Kingdom
Radboud University
Nijmegen Medical Centre
-
Netherlands
-
Netherlands
Royal Free London NHS Foundation Trust
NW3 2QG
United Kingdom
United Kingdom
Sapienza University of Rome
-
Italy
Italy
University Lille Nord de France
-
France
France
University College London Hospital (lead site)
NW1 2BU
United Kingdom
United Kingdom
Sponsor information
UCL Clinical Trials Unit
Hospital/treatment centre
Hospital/treatment centre
Rockefeller Office Room 233
Rockefeller Building
21 University Street
London
WC13 6DE
England
United Kingdom
"ROR" |
https://ror.org/001mm6w73 |
|---|
Funders
Funder type
Government
National Institute for Health Research
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 12/10/2017 | 09/08/2019 | Yes | No |
| Results article | results | 10/05/2018 | 09/08/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
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.
