Population-Based Prostate Cancer Screening With Magnetic Resonance Imaging or Ultrasonography

Abstract

IMPORTANCE Screening for prostate cancer using prostate-specific antigen (PSA) testing can lead to problems of underdiagnosis and overdiagnosis. Short, noncontrast magnetic resonance imaging (MRI) or transrectal ultrasonography might overcome these limitations. OBJECTIVE To compare the performance of PSA testing, MRI, and ultrasonography as screening tests for prostate cancer. DESIGN, SETTING, AND PARTICIPANTS This prospective, population-based, blinded cohort study was conducted at 7 primary care practices and 2 imaging centers in the United Kingdom. Men 50 to 69 years of age were invited for prostate cancer screening from October 10, 2018, to May 15, 2019. INTERVENTIONS All participants underwent screening with a PSA test, MRI (T2 weighted and diffusion), and ultrasonography (B-mode and shear wave elastography). The tests were independently interpreted without knowledge of other results. Both imaging tests were reported on a validated 5-point scale of suspicion. If any test result was positive, a systematic 12-core biopsy was performed. Additional image fusion-targeted biopsies were performed if the MRI or ultrasonography results were positive. MAIN OUTCOMES AND MEASURES The main outcome was the proportion of men with positive MRI or ultrasonography (defined as a score of 3-5 or 4-5) or PSA test (defined as PSA Ն3 μg/L) results. Key secondary outcomes were the number of clinically significant and clinically insignificant cancers detected if each test was used exclusively. Clinically significant cancer was defined as any Gleason score of 3+4 or higher. RESULTS A total of 2034 men were invited to participate; of 411 who attended screening, 408 consented to receive all screening tests. The proportion with positive MRI results (score, 3-5) was higher than the proportion with positive PSA test results (72 [17.7%; 95% CI, 14.3%-21.8%] vs 40 [9.9%; 95% CI, 7.3%-13.2%]; P < .001). The proportion with positive ultrasonography results (score, 3-5) was also higher than the proportion of those with positive PSA test results (96 [23.7%; 95% CI, 19.8%-28.1%]; P < .001). For an imaging threshold of score 4 to 5, the proportion with positive MRI results was similar to the proportion with positive PSA test results (43 [10.6%; 95% CI, 7.9%-14.0%]; P = .71), as was the proportion with positive ultrasonography results (52 [12.8%; 95% CI, 9.9%-16.5%]; P = .15). The PSA test (Ն3 ng/mL) detected 7 clinically significant cancers, an MRI score of 3 to 5 detected 14 cancers, an MRI score of 4 to 5 detected 11 cancers, an ultrasonography score of 3 to 5 detected 9 cancer, and an ultrasonography score of 4 to 5 detected 4 cancers. Clinically insignificant cancers were diagnosed by PSA testing in 6 cases, by an MRI score of 3 to 5 in 7 cases, an MRI score of 4 to 5 in 5 cases, an ultrasonography score of 3 to 5 in 13 cases, and an ultrasonography score of 4 to 5 in 7 cases. CONCLUSIONS AND RELEVANCE In this cohort study, when screening the general population for prostate cancer, MRI using a score of 4 or 5 to define a positive test result ...

The diagnostic impact of UK regional variations in age‐specific prostate‐specific antigen guidelines

“…In contrast, the five-strata model 10 led to the most men avoiding referral (14.6%), but also the most missed diagnoses (11.5%). A further consideration is whether it is time to abandon age-reference PSA models and move to alternative screening tests such as PSA density (PSA corrected for prostate volume), novel biomarkers such as Prostate Health Index (PHI) and 4K, or indeed primary MRI [6][7][8].…”

ESUR/ESUI position paper: developing artificial intelligence for precision diagnosis of prostate cancer using magnetic resonance imaging

“…It is also important to remember that while multiparametric, multiplane MRI has been extensively clinically validated, bpMRI with single axial imaging plane imaging has not undergone such rigorous evaluations for being able to direct prostate biopsies [14]. With promising studies underway to ascertain the value of bpMRI alone [39], this might change in the future. Readers should note that in the sub-analysis of the 4M data there was a 70% increase in the uncertain category when single plane bpMRI was evaluated [12].…”

Comparative Effectiveness of Techniques in Targeted Prostate Biopsy

“…The dynamic contrast-enhanced (DCE) phase plays a predominant role in post-treatment evaluation [38]. A recent prospective, blinded-cohort study evaluated bpMRI combined with ultrasonography (B-mode and shear wave elastography) as an alternative to population screening for PCa [39]. Any suspicious lesions identified on mpMRI (internal mpMRI score 3-5) or TRUS were targeted in the biopsy, in addition to a 12-core TP biopsy.…”