Active Observation of Biochemical Recurrence without Treatment following Radical Prostatectomy: Long-Term Analysis of Outcomes.

Biochemical recurrence (BCR) following radical prostatectomy (RP) is an unreliable predictor of prostate cancer (PC) progression. This study was a retrospective cohort analysis of prospectively collected data (407/1895) of men with BCR at a tertiary referral center. Patients were assessed for active observation (AO) compared with a treatment group (TG) utilizing doubling time (DT) kinetics. Risk assessment was based on the initial DT (>12 vs. <12 months), then based on the DT pattern (changed over time). Those with unstable, rapidly decreasing DTs received treatment. Those with increasing and slowly decreasing DTs prompted observation. The primary outcome was PC mortality, safety, and efficacy of observations based on DT kinetics. The secondary outcome was BCR patients managed with or without treatment. The median follow-up was 7.5 years (IQR 3.9−10.7). The PCSM in TG and AO was 10.7% and 0%, respectively (p < 0.001). The initial DT was >12 months in 73.6% of AO versus 22.6% of TG (p < 0.001). An increasing DT pattern was observed in 71.5% of AO versus 32.7% of TG (p < 0.001). Utilizing the Cleveland Clinic's PCSM nomogram, at 10 years, predicted and observed PCSM was 8.6% and 9.5% (p = 0.78), respectively. In conclusion, one-third of patients with BCR post-RP were managed without treatment using DT kinetics, avoiding treatment-related complications, quality-of-life issues, and expenses.

Prostate-Specific Antigen Doubling Time Kinetics following Radical Prostatectomy to Guide Need for Treatment Intervention: Validation of Low-Risk Recurrences.

Biochemical recurrence (BCR) following radical prostatectomy (RP) has a limited ability to predict prostate cancer (PC) progression, leading to overtreatment, decreased quality of life, and additional expenses. Previously, we established that one-third of men with BCR in our group experienced low-risk recurrences that were safely observed without treatment. Our retrospective cohort analysis of 407 BCR patients post RP validates the use of PSA doubling time (DT) kinetics to direct active observation (AO) versus treatment following RP. The primary outcome was no need for treatment according to the predictive value of models of ROC analysis. The secondary outcome was PC-specific mortality (PCSM) according to Kaplan−Meier analysis. A total of 1864 men underwent RP (June 2002−September 2019); 407 experienced BCR (PSA > 0.2 ng/dL, ×2), with a median follow-up of 7.6 years. In adjusted regression analysis, initial PSADT > 12 months and increasing DT were significant predictors for AO (p < 0.001). This model (initial PSADT and DT change) was an excellent predictor of AO in ROC analysis (AUC = 0.83). No patients with initial PSADT > 12 months and increasing DT experienced PCSM. In conclusion, the combination of PSADT > 12 months and increasing DT was an excellent predictor of AO. This is the first demonstration that one-third of BCRs are at low risk of PCSM and can be managed without treatment via DT kinetics.

Retrospective Concomitant Nonrandomized Comparison of "Touch" Cautery Versus Athermal Dissection of the Prostatic Vascular Pedicles and Neurovascular Bundles During Robot-assisted Radical Prostatectomy.

BACKGROUND: During robotic-assisted radical prostatectomy (RARP), the use of electrocautery near the neurovascular bundles (NVBs) frequently results in thermal injury to the cavernous nerves. The cut and "touch" monopolar cautery technique has been suggested to reduce desiccating thermal injury caused by bipolar energy when vessels are sealed. OBJECTIVE: To compare potency outcomes between an athermal technique (AT) and touch cautery (TC) to transect the prostatic vascular pedicles (PVPs) and dissect the NVBs. DESIGN, SETTING, AND PARTICIPANTS: A retrospective concomitant nonrandomized study of AT versus TC was performed in 733 men. A total of 323 undergoing AT had "thin" pedicles, easily suitable for suture ligation. TC was based on "thick" pedicles (n = 230) difficult to suture ligate. Men were excluded for an International Index of Erectile Function (IIEF-5) score of <15 or adjuvant therapies (n = 180). SURGICAL PROCEDURE: Single-surgeon RARP. MEASUREMENTS: Patient-reported outcomes with erectile function (EF) recovery defined as two affirmative answers to erections sufficient for intercourse (ESI; "are erections firm enough for penetration?" and "are the erections satisfactory?"), IIEF-5 scores 15-25, and a novel percent fullness score comparing pre- versus postoperative erection fullness. Logistic regression models assessed the correlation between cautery technique, covariates, and EF recovery. RESULTS AND LIMITATIONS: In an unadjusted analysis, preoperative IIEF-5, age, body mass index (BMI), and prostate weight were significant predictors of potency recovery. Follow-up was similar (AT 52.7 mo vs TC 54.6 mo, p = 0.534). In logistic regression, preoperative IIEF-5, age, and BMI were significant predictors of EF recovery, defined as IIEF-5 scores 15-25, ESI, and percent fullness >75%. Results were similar when IIEF-5 and percent fullness were assessed continuously. CONCLUSIONS: During transection of the PVPs and dissection of the NVBs, TC did not impact EF recovery significantly, compared with an AT. PATIENT SUMMARY: Electrocautery can be applied safely, with similar outcomes to those of an athermal technique.

Evidence for the integration of total and free testosterone levels in the management of prostate cancer.

OBJECTIVE: To comprehensively assess total and calculated free testosterone levels in a consecutive group of patients with prostate cancer (PCa) and any potential impact on disease aggressiveness and recurrence outcomes. PARTICIPANTS AND METHODS: The study included a single-centre prospective cohort of 882 patients presenting for radical prostatectomy from 2009 to 2018. Data on total testosterone (TT), sex hormone-binding globulin (SHBG), and calculated free testosterone (cFT) were prospectively collected. Stepwise logistic regression models were used to assess correlations of TT and cFT with pathological Gleason Grade Group (GGG), extraprostatic extension (EPE), seminal vesicle invasion (SVI) and biochemical recurrence (BCR). RESULTS: Total testosterone remained nearly constant across decades (40s-80s): 0.09 decrease/year (R = 0.02), while SHBG increased 0.87/year (R = 0.32) and cFT decreased 0.08/year (R = -0.02). Low cFT of <5.5 independently predicted: very-high-risk GGG (odds ratio [OR] 0.435, 95% confidence interval [CI] 0.846-0.994; P = 0.036), EPE (OR 0.557, 95% CI 0.810-0.987; P = 0.011), SVI (OR 0.396, 95% CI 0.798-1.038; P = 0.059), and BCR within 1 year after robot-assisted radical prostatectomy (OR 0.638, 95% CI 0.971-3.512, P = 0.046). TT was not a predictor. CONCLUSION: In contrast to popular belief, testosterone remained stable in men aged 40-80 years, whereas free testosterone decreased by 2-3%/year. Low cFT was an independent predictor of very-high-risk PCa and BCR.

A Systematic Review of Literature Regarding Whether Immediate Preoperative Hemoglobin A1c or Serum Glucose Are Risk Factors for Infection Following Penile Prosthesis Implantation.

Defining risks associated with diabetes mellitus (DM) in patients undergoing penile prosthesis (PP) implantation remains controversial. This systematic review seeks to assess whether preoperative hemoglobin a1c (HbA1c) or serum glucose have been shown to predict infection following PP implantation in diabetic men. A stepwise literature search was performed. Eight and four studies assessing HbA1c and serum glucose respectively were included. Overall, data exploring HbA1c and serum glucose on PP infection were heterogeneous in time period, study design, and patient populations. Contemporary studies did not support either HbA1c nor blood glucose as predictors of PP infection in diabetic men.

Impact of statin use on overall and time to biochemical failure following radical prostatectomy or radiation therapy.

OBJECTIVES: To assess the impact of statin use on overall and time to biochemical failure following primary treatment of localized prostate cancer (PCa). SUBJECTS/PATIENTS AND METHODS: 1581 patients undergoing radical prostatectomy (RP) or radiation therapy (RT) for primary treatment of PCa between July 2007 and January 2020 were evaluated for statin use, demographic/oncologic characteristics, and biochemical outcomes. Rate of biochemical failure (BF) was assessed overall and at 1, 3, and 5 years; time to BF was estimated with Kaplan-Meier. Logistic and linear regression were used to control for treatment modality and disease characteristics. RESULTS: The average age was 63.0 ± 7.5 years and median pre-treatment PSA was 6.55 (IQR 4.94). 1473 (93.2%) and 108 (6.8%) underwent RP and RT, respectively. RP patients were younger, had lower pre-PSA, lower BMI, and lower risk disease. At 3.4 ± 2.7 years follow-up, 323 (20.4%) experienced BF. When stratified by statin use, BF overall and within 1, 3, and 5 years were not different. Time to BF, was lower in patients using statins (1.8 ± 1.9 years vs. 2.4 ± 2.6 years; p = 0.016). These results persisted in multivariate analysis, wherein statin use was not associated with BF but was associated with a shorter time to BF. CONCLUSION: Overall, statin use was not associated with a reduced risk of BF in RP or RT patients. However, for patients with BF, statin use was associated with a decreased time to BF. Future investigations are warranted to further elucidate the impact of statin use on PCa recurrence.

Protective Effects of Metformin Against Biochemical Failure Following Radical Prostatectomy or Radiation Therapy in Localized Prostate Cancer.

OBJECTIVE: To assess the impact of metformin on biochemical failure (BF) in localized prostate cancers (PC) treated with radical prostatectomy or radiation therapy. MATERIALS AND METHODS: About 1449 patients undergoing radical prostatectomy (n = 1338, 92.3%) or radiation therapy (n = 108, 7.5%) for localized PC between July 2007 and January 2020 were evaluated for metformin use, demographic/oncologic characteristics, and biochemical outcomes. Androgen deprivation therapy was utilized per NCCN guidelines. BF rates were assessed overall and at 1, 3, and 5 years. Time to BF was estimated via Kaplan-Meier; logistic regression and Cox proportionate hazards models were generated to adjust for significant differences. RESULTS: Of 1449 patients, 148 (10.2%) utilized metformin at time of diagnosis, while 1,301 (89.8%) did not. Patients on metformin were significantly older, had higher body mass indexes, and more aggressive disease (Gleason score >7). At a mean ± SD follow-up of 3.6 ± 2.6 years, patients on metformin were less likely to experience BF at later timepoints; however, univariate analysis showed no differences at 1, 3, and 5 years. In multivariate analysis, patients on metformin were significantly less likely to experience BF at 5 years and overall in both treatment groups. In Cox regression, metformin was independently associated with a 40% relative risk reduction in BF. CONCLUSION: In multivariate analysis, metformin use was associated with a significant risk reduction in BF overall and at 5 years following primary treatment; this trend was not witnessed in univariate analysis. This suggests the need for future investigations of metformin's role in disease-free survival in men with localized PC.

Predictability and Practicality of Image-Based Scoring Systems for Patient Assessment and Outcome Stratification During Percutaneous Nephrolithotomy: a Contemporary Update.

Preoperative nomograms offer systematic and quantitative methods to assess patient- and stone-related characteristics and their impact on successful treatment and potential risk of complication. Discrepancies in the correlation of perioperative variables to patient outcomes have led to the individual development, validation, and application of four independent scoring systems for the percutaneous nephrolithotomy: Guy's stone score, S.T.O.N.E. nephrolithometry, Clinical Research Office of the Endourology Society nomogram, and Seoul National University Renal Stone Complexity. The optimal nomogram should have high predictive ability, be practically integrated into clinical use, and be widely applicable to urinary stone disease. Herein, we seek to provide a contemporary evaluation of the advantages, disadvantages, and commonalities of each scoring system. While the current data is insufficient to conclude which scoring system is destined to become the gold standard, it is crucial that a nephrolithometric scoring system be incorporated into common practice to improve surgical planning, patient counseling, and outcome assessment.