Digital rectal examination impact on PSA derivatives and prostate biopsy triggers: a contemporary study.

OBJECTIVE: To evaluate the impact of the digital rectal exam (DRE) on PSA measurements and clinical decision-making. METHODS: Healthy male volunteers between 50 and 70 years old were recruited during a 30-day public screening program. PSA levels were measured using two different methods (standard enhanced chemiluminescence immunoassay-ECLIA, and novel immunochromatography assay-ICA/rapid PSA) in the same blood sample. Two blood samples were drawn; first before DRE and the second 30-40 min after DRE. The effect of DRE on PSA levels and its impact on clinical decision-making for individual patients were evaluated based on different biopsy trigger cutoffs. RESULTS: ECLIA-PSA was measured in 74 participants both pre- and 37 ± 5 min post-DRE, mean age 57.2 ± 8.3 years, and mean prostate volume 33.6 (20-80) cm3. Both total and free ECLIA-PSA increased significantly after DRE (mean increase of 0.47 and 0.26 ng/ml, respectively, both p < 0.001). Different internationally accepted biopsy triggers were reached after DRE only: 5 total PSA > 3 ng/ml, 13 increase > 0.75 ng/ml, 3 PSA density > 0.15, and 1 free/total PSA < 0.18. On two occasions, patients were pushed away from biopsy trigger after DRE due to free/total PSA > 0.18. ICA-PSA was detectable (> 2.0 ng/ml) in 5 of 45 measured samples (11%) before DRE and 13/45 (29%) after DRE, p = 0.0316. Four among five detectable ICA-PSA tests increased after DRE. CONCLUSION: Performing DRE immediately before PSA measurement might change the clinical decision-making on a significant number of occasions (roughly 1 in 3); even though the mean increase (0.47 ng/ml) looks deceivingly small. Further studies are required that include gold standard tests (biopsy, or imaging).

The Biopsychosocial Burden of Prostate Biopsy at the Time of Its Indication, Procedure, and Pathological Report.

PURPOSE: To explore the burden of prostate biopsy at the time of its indication, procedure, and pathological report in the prostate cancer-screening scenario that is neglected and underestimated in the literature. METHODS: Prostate biopsy was offered to 47 consecutive patients with prostate-specific antigen (PSA) over 4 ng/dl or suspicious digital rectal examination (DRE) of whom 16 had undergone a biopsy. Comprehensive validated questionnaires at Time 0 (prebiopsy), Time 1 (before diagnosis, 20 days after biopsy), and Time 2 (after diagnosis, 40 days after biopsy) accessed patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI), hopelessness (BHS), and depression (BDI), added to the emotional thermometers including five visual analog scales for distress, anxiety, depression, anger, and need for help. The Mann-Whitney or Friedman tests were obtained among times and studied variables. RESULTS: Prostate biopsy did not significantly impact patients' erectile and voiding functions while a higher Beck anxiety index (BAI) was observed at Time 0 (6.89 ± 6.33) compared to Time 1 (4.83 ± 2.87), p=0.0214, and to Time 2 (4.22 ± 4.98), p=0.0178. At Time 0, patients that experienced a previous biopsy presented higher distress (3.1 ± 3.0 vs. 1.6 ± 2.3), p=0.043, and emotional suffering thermometer scores (2.3 ± 3.3 vs. 0.9 ± 2.4) compared to those undergoing the first biopsy, p=0.036. At Time 2, patients with positive biopsies compared with those with negative ones showed no significant difference in outcome scores. The sample power was >90%. CONCLUSIONS: To be considered in patients' counseling and care, the current study supports the hypothesis that the peak burden of prostate biopsy occurs at the time of its indication and might be higher for those experiencing rebiopsy, significantly impacting patients' psychosocial domains. TRIAL APPROVAL: This trial is registered under number NCT03783741.

Steroid Hormone Receptors as Potential Mediators of the Clinical Effects of Dutasteride: A Prospective, Randomized, Double-Blind Study.

This study characterizes the clinical and morphofunctional effects of a 5α-reductase inhibitor on steroid hormone receptors in normal human prostate tissue, as potential mediators of the clinical effects of dutasteride. This work was a prospective, double-blind, and randomized study that evaluated 49 men aged between 45 and 70 years, with no alterations in a digital rectal examination and prostate-specific antigen measurements between 2.5 and 4.0 ng/mL. These patients underwent prostate biopsy guided by transretal ultrasound with prostate neoplasia being ruled out, and the patients were divided into two groups, with one group receiving dutasteride ( n = 25) and one group receiving a placebo ( n = 24). The patients were clinically assessed each quarter, and at the end of 12 months they underwent new laboratory tests, prostate rebiopsy, and histopathological, immunohistochemical and clinical analyses. The estrogen receptor-beta (ERß) and androgen receptor immunoreactivities were higher, and the proliferation/apoptotic ratio was significantly lower with predominance of the apoptotic process, followed by a significant reduction in the prostate volume and the total serum prostate-specific antigen levels in the dutasteride group when compared with the placebo group, with a clear supremacy of ERß. There were no significant variations in the serum estrogen and testosterone levels, in the body mass index, or in the ERα immunoreactivities in the dutasteride and placebo groups. The results demonstrated the importance of the ERß pathway in the activation mechanisms of apoptosis, exerting a protective effect in the normal prostate, indicating that this receptor might be an important mediator of the clinical effects of dutasteride.