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Utility of PSA density in patients with PI-RADS 3 lesions across a large multi-institutional collaborative
Johnathan Drevik1, Zafardjan Dalimov1, Robert Uzzo2
1Einstein Healthcare Network, Department of Urology, Philadelphia, PA.
Introduction:
Prostate MRI detecting PI-RADs = 3 lesions has low diagnostic utility for prostate malignancy. Use of PSA density has been suggested to further risk-stratify these men, to potentially avoid biopsies in favor of monitoring. We evaluate the ability of PSA density (PSAd) to risk-stratify PIRADs 3 lesions across patients who underwent a prostate biopsy in a large multi-institutional collaborative.
Materials And Methods:
Pennsylvania Urology Regional Collaborative (PURC) is a voluntary quality improvement collaborative of 11 academic and community urology practices in Pennsylvania and New Jersey. A retrospective analysis was performed on all patients in the PURC database that had a prostate MRI with PI-RADs 3 lesions only. PSA just before the MRI and prostate size reported on MRI were used to calculate the PSA. Clinicopathologic data were evaluated. Univariable analysis using Chi-Square and Kruskal Wallis tests and multivariable logistic regression were used to identify predictors of any PCa, and clinically significant prostate cancer (csPCa) was defined as ≥ Grade Group 2 (GG2.) RESULTS: Between May 2015 and March 2021, 349 patients with PIRADs 3 lesions only were identified and comprised the cohort of interest. Median PSA was 5.0 with a prostate volume of 58cc and a median PSA density of 0.11, 10.6% of the cohort was African American with 81.4% being Caucasian. Significant prostate cancer was detected in 70/349 (20.0%) men. Smaller prostate volume, abnormal DRE, and higher PSAd were significantly associated with clinically significant prostate cancer on univariable analysis. In men with PSAd <0.15, 31/228 (13.6%) harbored csPCa. Multivariable analysis confirmed that men with PSAd >0.15 were more likely to harbor clinically significant prostate cancer (P < 0.001).
Conclusion:
Across a large regional collaborative, patients with PIRADs 3 lesions on mpMRI were noted to have clinically significant cancer in 20% of biopsies. Using a PSA density cut-off of 0.15 may result in missing clinically significant prostate cancer in 13.6%. This information is useful for prebiopsy risk stratification and counseling.
Insights
Prostate MRI PI-RADS 3 lesions have low utility. PSA density (PSAd) can help risk-stratify these cases, potentially avoiding unnecessary biopsies. A PSAd cutoff of 0.15 may miss clinically significant prostate cancer.
Area of Science:
- Urology
- Radiology
- Oncology
Background:
- Prostate MRI PI-RADS 3 lesions have limited diagnostic value for malignancy.
- PSA density (PSAd) is proposed to improve risk stratification for these lesions.
- Avoiding unnecessary prostate biopsies is a key clinical goal.
Purpose of the Study:
- To evaluate the efficacy of PSA density in risk-stratifying men with PI-RADS 3 lesions.
- To determine if PSAd can help differentiate between indolent and clinically significant prostate cancer.
- To assess the rate of clinically significant prostate cancer in PI-RADS 3 lesions based on PSAd levels.
Main Methods:
- Retrospective analysis of 349 patients with PI-RADS 3 lesions from the Pennsylvania Urology Regional Collaborative (PURC).
- Calculation of PSA density (PSAd) using PSA levels and prostate volume from MRI.
- Univariable and multivariable logistic regression to identify predictors of clinically significant prostate cancer (csPCa, Grade Group ≥2).
Main Results:
- 20% of patients with PI-RADS 3 lesions were diagnosed with csPCa.
- Lower prostate volume, abnormal DRE, and higher PSAd were associated with csPCa.
- In men with PSAd <0.15, 13.6% had csPCa, while multivariable analysis showed PSAd >0.15 predicted csPCa (P < 0.001).
Conclusions:
- PI-RADS 3 lesions on prostate MRI have a 20% detection rate for clinically significant prostate cancer.
- A PSA density cutoff of 0.15 may miss a significant proportion of csPCa.
- PSAd is a valuable tool for pre-biopsy risk stratification and patient counseling in PI-RADS 3 cases.
