Is prostate biopsy necessary in patients with negative or similar MRI and low PSA density?

A new meta-analysis found that PI-RADS 4 and 5 lesion assessment on magnetic resonance imaging (MRI) as well as prostate-specific antigen density (PSAID) is predictive of clinically significant prostate cancer (csPCa). were the only predictive factors associated with.

In a meta-analysis, recently published jama network open, researchers reviewed data from 72 studies involving a total of 36,366 patients (mean age 65.6 years) with suspected cSPCA. According to the meta-analysis, all patients in the reviewed studies had transrectal and/or transperineal prostate biopsy, and prostate MRI before biopsy.

The researchers found that 30 percent of unnecessary prostate biopsies could be avoided if physicians skipped biopsy for patients with PSAD levels below .10 ng/mL and MRI lesion assessment of PI-RADS 3 or less. By increasing the PSAD level threshold to below .15 ng/mL, the study authors suggested that 48 percent of unnecessary biopsies could be eliminated.

“Our results suggest that combining PI-RADS with PSAD will reduce the number of unnecessary biopsies and improve diagnostic yield. Although a staged approach based on PI-RADS and PSAD has been used in some institutions to guide decisions toward prostate biopsy, current guidelines are against biopsy in patients with similar MRI findings given the low PSAD and lack of level 1 Do not advise. The evidence,” maintained lead study author Arya Haj-Mirjian, MD, MPH, who is affiliated with the Center for Evidence-Based Imaging and the Department of Radiology at Brigham and Women's Hospital in Boston, and colleagues. “This meta-analysis provides evidence that could potentially influence the development of these guidelines.”

three main things

  1. PI-RADS and PSAD for risk stratification. PI-RADS 4 and 5 lesion assessment on MRI, along with prostate-specific antigen density (PSAD), serve as valuable prognostic factors for clinically significant prostate cancer (cSPCA). Integrating both PI-RADS and PSAD may aid in risk stratification and decision making regarding prostate biopsy.
  2. Reduction in unnecessary biopsies. Meta-analysis shows that incorporating PSAD level and MRI lesion assessment can lead to a significant reduction in unnecessary prostate biopsies. Thresholds for PSAD, typically below 0.10 ng/mL2Can help identify patients who may not need an immediate biopsy, potentially avoiding unnecessary procedures.
  3. Improved diagnostic yield. The combination of PI-RADS with PSAD increases the diagnostic yield for detecting cSPCA. Sensitivity rates and negative predictive values ​​are remarkably high when using specific thresholds for PSAD with MRI lesion assessment, which may help optimize biopsy decisions while maintaining diagnostic accuracy.

The combination of no focal lesions, PI-RADS 2 or lower lesion assessment on MRI, and a PSAD level less than 0.10 ng/mL2 had a sensitivity rate of 83 percent, compared with 66 percent for PSAD less than 0.15 ng/mL2 and 35 percent for PSAD less than 0.15 ng/mL. The percentage was. According to the meta-analysis authors, less than 0.20 ng/mL2.

Based on findings from eight of 10 studies, the researchers also noted that PI-RADS 3 lesion assessment and avoidance of prostate biopsy in patients with PSAD less than 0.10 ng/mL had a sensitivity rate of 85 percent and a negative predictive value of 93. Maintained. Percent.

For patients without focal lesions, PI-RADS assessment less than or equal to PI-RADS 3 and PSAD level less than 0.10 ng/mL2, the meta-analysis authors pointed to a 97 percent sensitivity rate and 94 percent NPV. .

“Despite high sensitivity, 3% to 5% of CSPCA cases may still be missed by this approach. This concern could be addressed by future prospective studies by using a lower threshold for PSAD and incorporating additional variables for further risk stratification,” Haj-Mirjian and colleagues said.

Regarding study limitations, the authors acknowledged that only a few of the reviewed studies examined clinical variables. They also acknowledged that the evaluation of the combination of PI-RADS assessment and PSAD was based on a pooled analysis of six to 11 studies with cohorts of 1,454 to 5,288 patients.

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