PT  - JOURNAL ARTICLE
AU  - Robert Nam
AU  - Chirag Patel
AU  - Laurent Milot
AU  - Amanda Hird
AU  - Christopher Wallis
AU  - Patrick Macinnis
AU  - Mala Singh
AU  - Urban Emmenegger
AU  - Christopher Sherman
AU  - Masoom A Haider
TI  - Prostate MRI versus PSA screening for prostate cancer detection (the MVP Study): a randomised clinical trial
AID  - 10.1136/bmjopen-2021-059482
DP  - 2022 Nov 01
TA  - BMJ Open
PG  - e059482
VI  - 12
IP  - 11
4099  - http://bmjopen.bmj.com/content/12/11/e059482.short
4100  - http://bmjopen.bmj.com/content/12/11/e059482.full
SO  - BMJ Open2022 Nov 01; 12
AB  - Objectives Our objective was to compare prostate cancer detection rates between patients undergoing serum prostate-specific antigen (PSA) vs magnetic resonance imaging (MRI) for prostate cancer screening.Design Phase III open-label randomised controlled trial.Setting Single tertiary cancer centre in Toronto, Canada.Participants Men 50 years of age and older with no history of PSA screening for ≥3 years, a negative digital rectal exam and no prior prostate biopsy.Interventions Patients were recommended to undergo a prostate biopsy if their PSA was ≥2.6 ng/mL (PSA arm) or if they had a PIRADS score of 4 or 5 (MRI arm). Patients underwent an end-of-study PSA in the MRI arm.Primary and secondary outcome measures Adenocarcinoma on prostate biopsy. Prostate biopsy rates and the presence of clinically significant prostate cancer were also compared.Results A total of 525 patients were randomised, with 266 in the PSA arm and 248 in the MRI arm. Due to challenges with accrual and study execution during the COVID-19 pandemic, the study was terminated early. In the PSA arm, 48 patients had an abnormal PSA and 28 (58%) agreed to undergo a prostate biopsy. In the MRI arm, 25 patients had a PIRADS score of 4 or 5 and 24 (96%) agreed to undergo a biopsy. The relative risk for MRI to recommend a prostate biopsy was 0.52 (95% CI 0.33 to 0.82, p=0.005), compared with PSA. The cancer detection rate for patients in the PSA arm was 29% (8 of 28) vs 63% (15 of 24, p=0.019) in the MRI arm, with a higher proportion of clinically significant cancer detected in the MRI arm (73% vs 50%). The relative risk for detecting cancer and clinically significant with MRI compared with PSA was 1.89 (95% CI 0.82 to 4.38, p=0.14) and 2.77 (95% CI 0.89 to 8.59, p=0.07), respectively.Conclusions Prostate MRI as a stand-alone screening test reduced the rate of prostate biopsy. The number of clinically significant cancers detected was higher in the MRI arm, but this did not reach statistical significance. Due to early termination, the study was underpowered. More patients were willing to follow recommendations for prostate biopsy based on MRI results.Trial registration number NCT02799303.No data are available. Individual participant data that underlie the results reported in this article will not be shared. The study protocol will be made available online.