Abstract
The association between PSA density, prostate cancer (PCa) and BPH is well established. The aim of the present study was to establish whether PSA density can be used as a reliable parameter to predict csPCa and to determine its optimal cutoff to exclude increased PSA levels due to intraprostatic inflammation. This is a large prospective single-center, observational study evaluating the role of PSA density in the discrimination between intraprostatic inflammation and clinically significant PCa (csPCa). Patients with PSA ≥ 4 ng/ml and/or positive digito-rectal examination (DRE) and scheduled for prostate biopsy were enrolled. Prostatic inflammation (PI) was assessed and graded using the Irani Scores. Multivariable binary logistic regression analysis was used to assess if PSA density was associated with clinically significant PCa (csPCa) rather than prostatic inflammation. A total of 1988 patients met the inclusion criteria. Any PCa and csPCa rates were 47% and 24% respectively. In the group without csPCa, patients with prostatic inflammation had a higher PSA (6.0 vs 5.0 ng/ml; p=0.0003), higher prostate volume (58 vs 52 cc; p<0.0001), were more likely to have a previous negative biopsy (29% vs 21%; p=0.0005) and a negative DRE (70% vs 65%; p=0.023) but no difference in PSA density (0.1 vs 0.11; p=0.2). Conversely in the group with csPCa, patients with prostatic inflammation had a higher prostate volume (43 vs 40 cc; p=0.007) but no difference in the other clinical parameters. At multivariable analysis adjusting for age, biopsy history, DRE and prostate volume, PSA density emerged as a strong predictor of csPCA but was not associated with prostatic inflammation. The optimal cutoffs of PSA density to diagnose csPCa and rule out the presence of prostatic inflammation in patients with an elevated PSA (>4 ng/ml) were 0.10 ng/ml2 in biopsy naïve patients and 0.15 ng/ml2 in patients with a previous negative biopsy. PSA density rather than PSA, should be used to evaluate patients at risk of prostate cancer who may need additional testing or prostate biopsy. This readily available parameter can potentially identify men who do not have PCa but have an elevated PSA secondary to benign conditions.
Highlights
“There is moderate certainty that the benefits of prostate-specific antigen (PSA)-based screening for prostate cancer (PCa) do not outweigh the harms”
To date there is no evidence that inflammation or benign prostatic hyperplasia (BPH) leads to prostate cancer, but it is possible for a man to have one or both conditions and to develop PCa as well
Patients diagnosed with any PCa (GGG1) and csPCa (GGG≥2) were older, had greater PSA and PSA density suspicious digital rectal examination (DRE) and Qmax, but lower prostate volume, post void residual volume (PVR) and International Prostate Symptom Score (IPSS) than those without cancer
Summary
“There is moderate certainty that the benefits of prostate-specific antigen (PSA)-based screening for prostate cancer (PCa) do not outweigh the harms”. In 2012, based on the results of two large-scale randomized clinical trials (RCT’s), the United States Preventive Services Task Force (USPSTF) issued a grade D recommendation discouraging PSA-based screening [1]. Since this strategy could lead to a substantial number of men with aggressive disease being missed, the USPSTF issued an updated statement in 2017. To date there is no evidence that inflammation or BPH leads to prostate cancer, but it is possible for a man to have one or both conditions and to develop PCa as well. The aim of the present study was to establish whether PSA density can be used as a reliable parameter to predict csPCa and to determine its optimal cutoff to exclude increased PSA levels due to intraprostatic inflammation
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