1. In this randomized controlled trial of men aged 50 to 60, forgoing prostate biopsies in those with elevated PSA but negative MRI reduced the diagnosis of clinically insignificant cancer.

2. MRI-negative men who did not undergo prostate biopsy did not have higher rates of incurable cancer diagnoses in follow-up screenings.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Current guidelines for prostate cancer screening recommend systematic biopsies for all men with elevated PSA levels. However, this approach often leads to overdiagnosis, primarily due to the low specificity of PSA and the high incidence of indolent, clinically insignificant cancers. Research has shown that MRI-targeted biopsies can reduce overdiagnosis. Yet, concerns persist that this method may miss clinically significant cancers, potentially allowing them to progress to an advanced, incurable stage before treatment is initiated. This study further analyzes the GÖTEBORG-2 screening trial to evaluate whether a screening algorithm beginning with PSA measurement, followed by MRI and targeted biopsy when indicated—is safe and effective for population-based prostate cancer screening. The results demonstrate that the detection of clinically insignificant cancers was significantly lower in the MRI-targeted biopsy group compared to the systematic biopsy group. Notably, there was no significant difference in detecting high-risk, clinically significant cancers between the two groups. Despite its strengths, the study has several limitations, including a restricted age range (with the maximum age at analysis being 67), a single-center design, a predominantly White participant population, and a 50% participation rate. Nonetheless, the findings suggest that a screening algorithm based on MRI-targeted biopsies can reduce unnecessary cancer diagnoses without increasing the risk of missing aggressive, potentially incurable cancers.

Click here to read the study in NEJM

In-Depth [randomized controlled trial]: This population-based trial assessed the efficacy and safety of incorporating MRI-targeted biopsy into prostate cancer screening protocols. Participants were men aged 50 to 60, living in Gothenburg, Sweden, or nearby cities between 2015 and 2020. No exclusion criteria were reported. Out of 38,316 men randomly selected for the study, 6,578 were assigned to the systematic biopsy group and 6,575 to the MRI-targeted biopsy group. In the study, an MRI was performed if a participant’s PSA level exceeded 3ng/mL, while those below this threshold were invited for future interval screenings. In the systematic biopsy group, MRI was always followed by systematic biopsy. In contrast, the MRI-targeted biopsy group underwent a biopsy only if suspicious lesions were detected on MRI. The primary outcome was the detection of clinically insignificant prostate cancer (ISUP grade 1). As of June 2022, men in the MRI-targeted biopsy group had a 57% lower risk of being diagnosed with clinically insignificant cancer compared to the systematic biopsy group (relative risk, 0.43; 95% confidence interval [CI], 0.32–0.57; p<0.001). Secondary outcomes included the detection of clinically significant cancer (ISUP grade 2 or higher) and high-risk cancer (either metastatic or ISUP grade 4 or 5). No significant difference was observed between the groups in detecting clinically significant cancer (relative risk, 0.84; 95% CI, 0.66–1.07) or high-risk cancer (relative risk, 0.65; 95% CI, 0.34–1.24). Screening-related complications were rare, with three severe adverse events reported in the systematic biopsy group and two in the MRI-targeted group. Overall, the results support the use of a screening algorithm that involves PSA measurement followed by MRI, with targeted biopsy only when indicated.

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