MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis
- Study type
- Clinical trial
- Study name
- PRECISION
- Design
- International multicentre randomised non-inferiority trial
- Sample size
- 500 men
- Source
- N Engl J Med · 2018
- Trial registration
- NCT02380027
In plain words
In the past, every man with a high PSA had a "blind" biopsy taken from several spots in the prostate. This study showed that if an MRI scan is done first and samples are taken only from suspicious areas, more important cancers are found, fewer unimportant cancers are diagnosed, and about one in four men does not need a biopsy at all.
Key results
Treatment arms and regimens
Multiparametric MRI (T2, diffusion and dynamic contrast-enhanced; PI-RADS version 2 reporting); for a lesion scoring 3, 4 or 5, targeted biopsy only, with real-time ultrasound guidance (up to 3 lesions and 4 cores per lesion; maximum 12 cores; no standard cores); if the MRI was not suspicious, no biopsy was offered. This trial involves no drug.
10- to 12-core transrectal ultrasound-guided (TRUS) biopsy.
Source of the regimen details: Full text of the paper (PMC9084630); diagnostic trial without a drug
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
500 biopsy-naive men referred with clinical suspicion of prostate cancer (raised PSA, abnormal digital rectal examination, or both); PSA 20 ng/mL or less, digital rectal examination without evidence of extracapsular extension, and suitable for biopsy and MRI.
Endpoints
Primary outcome: proportion of men diagnosed with clinically significant cancer. Key secondary outcome: proportion of men diagnosed with clinically insignificant cancer.
Safety and side effects
Patient-reported complications at 30 days were lower in the MRI group: haematuria 30% versus 63%, haematospermia 32% versus 60%, pain at the procedure site 13% versus 23%, rectal bleeding 14% versus 22% and erectile dysfunction 11% versus 16%. Serious adverse events 2% in each group.
Clinical significance and place in guidelines
PRECISION made the "MRI-first" pathway the standard of care. The EAU guideline recommends multiparametric MRI before biopsy to avoid unnecessary biopsies and, when biopsy is performed, suggests combining targeted and systematic biopsy.
Limitations
Results depend on MRI quality and radiologist experience; follow-up of men with a non-suspicious MRI who were not biopsied was short in this initial report; the comparator biopsy was transrectal, whereas the transperineal route is now more common.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.