medwireNews: The ProScreen trial points to the potential of a single round of prostate cancer screening involving a prostate-specific antigen (PSA) test, a kallikrein panel, and a magnetic resonance imaging (MRI) scan.
“[T]he screening intervention detected 1 high-grade prostate cancer per 196 men and 1 low-grade prostate cancer per 909 men invited to be screened,” report the researchers in JAMA.
But they caution that “[t]hese preliminary findings should be interpreted provisionally, pending results of the primary mortality outcome.”
Jeffrey Tosoian (Vanderbilt University Medical Center, Nashville, Tennessee, USA) and fellow authors of an accompanying editorial commend the investigators “for carrying out this highly informative study.”
They continue: “Although prior studies have demonstrated the benefits and harms of PSA screening followed by systematic biopsy, the current trial informs a more contemporary, pragmatic approach to screening, with appropriate use of biomarkers and imaging to optimize patient selection for biopsy.”
In the population-based clinical trial, conducted in Helsinki and Tampere in Finland, 61,193 men aged 50–63 years who did not have a prior prostate cancer diagnosis were randomly assigned to either be or not be invited for prostate cancer screening. And of the 15,201 men invited to undergo screening, 7744 (51%) participated.
Screening involved an initial PSA test, followed by additional testing for high-grade prostate cancer with a 4-kallikrein panel for those with a PSA level of at least 3.0 ng/mL. Participants with a kallikrein panel score of at least 7.5% were referred for a prostate MRI and those with abnormal findings underwent targeted biopsies. Men with a negative MRI only underwent biopsy if they had an elevated PSA density (≥0.15 ng/mL), in which case a systematic 12-core biopsy was recommended.
A total of 161 prostate cancers were detected among the men who underwent screening, of which 32 were low grade, 128 were high grade, and one had an unknown grade. This gave a cumulative incidence of 0.41% for low-grade cancers and 1.65% for high-grade cancers.
The corresponding rates among the men allocated to the intervention group who did not participate – based on data from the Finnish Cancer Registry – were 0.10% and 0.60%, while they were 0.26% and 1.13% for the entire intervention group.
Among the men who were not invited for screening (control group), the cumulative incidence of low- and high-grade prostate cancers was 0.14% and 0.62%, respectively.
Comparing the entire intervention group with the control group, Anssi Auvinen, from Tampere University, and team found a risk difference of 0.11% for low-grade prostate cancer and 0.51% for high-grade cancer.
They note, however, that “the absolute differences between the 2 randomized groups were small and their clinical importance remains unclear.”
But the editorialists highlight that “[c]ompared with early findings from the European Randomized Study of Screening for Prostate Cancer, the current study achieved comparable detection of high-grade cancer (1.7% vs 1.8%), while drastically reducing overdetection of low-grade disease (0.4% vs 3.2%).”
Tosoian et al continue: “This improvement is the result of more careful selection of patients for biopsy using biomarkers and MRI, reflecting the clear clinical advantages offered by current diagnostic tools relative to a PSA-only approach.”
And they conclude: “Although the long-term benefits of this approach will be better elucidated with follow-up, these early data already reflect more favorable stage distribution, more frequent management with active surveillance, and reduced use of androgen deprivation therapy in the screened population.
“With additional, collaborative efforts spanning research and clinical practice, even better care of patients is on the horizon.”
The findings were presented simultaneously at the 39th Annual European Association of Urology Congress in Paris, France.
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JAMA 2024; doi:10.1001/jama.2024.3841
JAMA 2024; doi:10.1001/jama.2024.4089
EAU 2024; Paris, France: 5–8 April