Among men aged 50 to 60 years with elevated PSA, use of MRI-targeted biopsy alone reduces the risk of prostate cancer overdiagnosis at the cost of missing a small proportion of clinically significant cancers, according to new study findings published in the New England Journal of Medicine.

Among 17,980 men aged 50 to 60 years in the GÖTEBORG-2 trial who underwent PSA screening, investigators randomly assigned 5994 to a reference group and 11,986 to an experimental group. All men in the reference group who had a PSA level of 3 ng/mL or higher underwent systematic biopsy. Select patients in the reference group with suspicious lesions on MRI, defined as PI-RADS score 3 to 5, also separately underwent targeted biopsy. Men in the experimental group who had a PSA level of 3 ng/mL or higher underwent targeted biopsy alone for suspicious PI-RADS 3 to 5 lesions. Those with PSA of 10 ng/mL or higher underwent systematic biopsy regardless. The finding of clinically insignificant prostate cancer (Gleason 3+3) was the study’s primary outcome.

The investigators found Gleason score 3+3 prostate cancer in a smaller proportion of the experimental than reference group (0.6% vs 1.2%), resulting in a significant 54% lower risk of overdiagnosis of clinically insignificant cancer with targeted biopsy alone, Jonas Hugosson, MD, PhD, of Sahlgrenska University Hospital in Gothenburg, Sweden, and colleagues reported. Gleason 3+3 cancers detected by targeted biopsy tended to be larger, the investigators noted.

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The likelihood of diagnosing clinically significant Gleason 3+4 or higher prostate cancer was 19% lower in the experimental group compared with the reference group, a nonsignificant difference between the groups, Dr Hugosson’s team reported. Systematic biopsy alone detected clinically significant cancer in an additional 10 patients in the reference group. All cases were intermediate-risk Gleason 3+4 with mostly low-volume disease that was managed with active surveillance, according to the investigators. Four patients received treatment.

Antibiotic prescription for urinary tract infection within 30 days was required by 0.1% of the reference group and 0.03% of the experimental group. Hospitalization within 30 days of biopsy occurred in 0.07% of the reference group and 0.008% of the experimental group. Urosepsis was the cause for 2 patients in the reference group and 1 patient in the experimental group. Dr Hugosson and colleagues noted that the cohort was relatively young, which probably contributed to low adverse event rates.

“Whether newer biopsy techniques, such as transperineal biopsy and image-guided fusion technology, may improve the diagnostic performance of the screening algorithm is unknown,” Dr Hugosson’s team acknowledged.

In an accompanying editorial, Roman Gulati, MS, of the Fred Hutchinson Cancer Research Center in Seattle, Washington, noted that prostate cancer screening and management are evolving.

“The history of PSA screening has shown us that difficult trade-offs between too much and too little diagnosis are inevitable,” Gulati wrote. “A reckoning is now needed with regard to whether more acceptable trade-offs can be achieved with the use of variables that are available before diagnosis, such as triage testing or MRI-targeted biopsy, or after diagnosis, such as relabeling clinically insignificant prostate cancer or using appropriate conservative management. The GÖTEBORG-2 trial provides another useful data point.”


Hugosson J, Månsson M, Wallström J, et al; the GÖTEBORG-2 Trial Investigators. Prostate cancer screening with PSA and MRI followed by targeted biopsy only. N Engl J Med 387:2126-2137. doi:10.1056/NEJMoa2209454

Gulati R. Reducing prostate cancer overdiagnosis. N Engl J Med 387:2187-2188. doi:10.1056/NEJMe2214658

This article originally appeared on Renal and Urology News