Are 10-, 10-12-, or > 12-mm prostate biopsy core quality control cutoffs reasonable?

PURPOSE: To explore the role of prostate biopsy core length on prediction of index tumor clinical significance and localization on radical prostatectomy (RP) and time to recurrence, hypothesizing 10-, 10-12-, or > 12-mm minimum core as potential biopsy quality control. METHODS: Assessed 2424 prostate biopsy cores and corresponding RP of 202 patients submitted to the first set of 12 cores prostate biopsy between 2010 and 2015. Analyzed biopsy core length, age, prostate volume (PV), free and total PSA ratio, PSA density, RP index tumor clinical significance, extension, localization, surgical margins, and cancer control. Prostate biopsy confronted to surgical specimens defined Gleason grade-grouping system (1-5) agreement. RESULTS: Median age was 63.7 years, PSA 10.1 ng/dl, PSA density 28%, and mean follow-up 5 years. Recurrence was identified in 64 (31.7%) patients and predicted by PSA > 10 at time of diagnosis (p = 0.008), seminal vesicle invasion (p = 0.0019), core tumor percentage (p = 0.033), and tumor localization predominantly in the prostate base (p = 0017). The mean core length was longer in index tumor positive cores (p = 0.043) and in tumors classified as clinically insignificant (p = 0.011), without impact on tumor localization (basal vs apical p = 0.592; left vs. right p = 0.320). Biopsy core length categories (≤ 10, 10-12 and > 12 mm) did not significantly impact Gleason grade-grouping agreement or time to recurrence (p > 0.05). Core length was not significantly different in all Gleason grade-groupings 1-5 (p = 0.312). CONCLUSION: Prostate biopsy core length impacts tumor characterization; however, 10 mm minimum core length and even 10-12- and > 12-mm categories failed as a biopsy quality control in our data.

Is there room for behavioral and modifiable health-related targets in the lower urinary tract symptoms' scenario.

PURPOSE: To better understand potential modifiable risk factors guiding preventive interventions against lower urinary tract symptoms (LUTS). METHODS: A prospective cross-sectional study, including healthy men aged 40-70 years under routine urological evaluation, measured the strength of association between the International Prostate Symptom Score (IPSS) and socio-demographic, lifestyle, and health-related factors using logistic and linear regression adjusted for confounding factors. Men with urethral or prostate surgery were excluded. RESULTS: Among 743 men, mean age 59.64 ± 9.66, 22.6% reported moderate, and 5.0% severe LUTS. The adjusted odds of severe LUTS increased with: increasing age (OR = 1.07, 95% CI = 1.05-1.09, p < .0001), increasing prostate volume (OR = 1.02, 95% CI = 1.01-1.04, p = .004), decreasing education (tertiary qualification, no versus yes, OR = 2.34; 95% CI = 1.16-4.70; p = .0133), delayed ejaculation (yes versus no, OR = 2.63, 95% CI = 1.43-4.83, p < .0001), and increasing blood pressure (systolic ≥130 mmHg, OR = 2.03, 95% CI = 1.44-2.86, p < .0001 or diastolic ≥85 mmHg, OR = 1.47, 95% CI = 1.03-2.10, p = .0345); severe LUTS decreased with: increasing the weekly sexual frequency (OR = 0.80, 95% CI = 0.69-0.91, p = .0012) and increasing HDL cholesterol (OR = 0.98, 95% CI = 0.97-0.99, p = .037). Odds were not significant for age of sexual initiation, precocious ejaculation, masturbatory pattern, physical activity, smoking, alcohol consumption, penile length (objective and subjective), abdominal circumference, obesity, comorbid conditions, metabolic syndrome, serum glycaemia, testosterone, SHBG, PSA, and estradiol. CONCLUSIONS: One in every four men under routine urological evaluation who considered themselves healthy present moderate and severe LUTS. Modifiable behavioral (education, sexual frequency, and ejaculation) and health-related (blood pressure and HDL cholesterol) targets were identified for future interventional studies and potential preventive actions and patient counseling.

Gleason underestimation is predicted by prostate biopsy core length.

PURPOSE: To evaluate whether core length impacts biopsy accuracy and Gleason score underestimation compared to radical prostatectomy (RP) specimens. METHODS: From 2010 to 2011, 8,928 cores were trans-rectal obtained from 744 consecutive patients (178 RP, 24%), 557 by an experienced performer (>250/year) and 187 (25%) by in-training urology residents. Prospectively analyzed variables were core length, age, prostate volume, free and total prostate-specific antigen (PSA), PSA density and free/total PSA ratio. RESULTS: Mean core length for Gleason upgrading on RP (42.7%, n = 76) was 11.61 (±2.5, median 11.40) compared to 13.52 (±3.2, median 13.70), p < 0.001 for perfect biopsy-RP Gleason agreement (57.3%, n = 102). In multivariate analysis, for each unit of core length increment in millimeter, the Gleason upgrading risk decreased 89.9%, p = 0.049 [odds ratio (OR) 0.10, 95% confidence interval (CI) 0.01-0.99]. Biopsy positivity between experienced (35.5%) and in-training performer (30.1%) was not significantly different (p = 0.20), with comparable mean patient age (65.1 vs. 64.1), prostate volume (52.3 vs. 50.7) and median PSA (5.2 vs. 5.1), respectively. Denoting wider variability in terms of core length, in-training performers obtained significantly larger cores for positive biopsies (11.33 ± 3.42 vs. 10.83 ± 3.68), p = 0.043, compared to experienced performer (11.39 ± 3.36 vs. 11.37 ± 3.64), p = 0.30. In multivariate analysis, PSA density (OR 1.14, 95% CI 1.02-1.28) and age (OR 1.04, 95% CI 1.01-1.07) were significantly associated with biopsy positivity, p = 0.021 and p = 0.011, respectively. CONCLUSION: While core length on trans-rectal biopsy independently affects Gleason upgrading on RP specimens, performer experience has minor impact on Gleason discordance or biopsy positivity due to a sharp learning curve.

Moreau Strain Bacillus Calmette-Guérin Low Versus Standard Dose in the Treatment of High-Grade T1 Bladder Cancer: A Retrospective Observational Cohort Study.

PURPOSE: To evaluate recurrence, progression, and cancer-specific mortality of high-grade T1 non-muscle-invasive bladder cancer by assessing receipt of a low dose of the underexplored bacillus Calmette-Guérin (BCG) Moreau strain in a retrospective observational cohort study. PATIENTS AND METHODS: From January 2006 to December 2015, a total of 219 consecutive patients with high-grade T1 non-muscle-invasive bladder cancer received half-dose (40 mg; n = 109) or standard-dose (80 mg; n = 110) BCG Moreau strain after transurethral resection of the bladder. BCG therapy was initiated 2 or 3 weeks after transurethral resection of the bladder using the following protocol: 6 weekly doses, 12 monthly, 4 once every 3 months, and 2 once every 6 months, with a total of 24 doses. RESULTS: Comparing the half-dose and standard-dose treatment groups, in a median follow-up of 74.6 months, recurrence (n = 51, 46.8% vs. n = 60, 54.5%, P = .28), progression (n = 18, 16.5% vs. n = 16, 14.5%, P = .69), and disease-specific mortality (n = 9, 8.3% vs. n = 5, 4.5%, P = .26) were not significantly different on Kaplan-Meier curves and log-rank test, respectively. Charlson comorbidity index was an independent predictor of death from disease (hazard ratio = 1.341; 95% confidence interval, 1.033-1.740; P = .0274); no predictor of recurrence or progression was identified. Treatment intolerance occurred in 1 (0.9%) versus 6 (5.4%) patients (P = .12), respectively. No hospital admission or systemic BCG toxicity was reported. CONCLUSION: To our knowledge, this is the largest low-dose Moreau BCG strain study in high-grade T1 scenario. A half dose of BCG Moreau strain might be safe and effective in terms of tumor control, progression, or cancer-specific mortality with a low complication rate, which is central to the worldwide scenario of BCG shortage, and can help regulatory agencies approve efficient daughter BCG strains.

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.