Does prior surgical interventional therapy for BPH affect the oncological or functional outcomes after primary whole-gland prostate cryoablation for localized prostate cancer?

BACKGROUND: To assess whether prior interventional treatment for benign prostatic hyperplasia (BPH) influences oncologic or functional outcomes following primary whole-gland prostate cryoablation. METHODS: Among 3831 men with prostate cancer who underwent primary whole-gland prostate cryoablation, we identified 160 with a history of prior BPH interventional therapy including transurethral needle ablation (n = 6), transurethral microwave thermotherapy (n = 9), or transurethral resection of the prostate (n = 145). Patients with a history of medically treated or unspecified BPH therapy were excluded from the study. Oncological and functional outcomes were compared between men with and without prior BPH interventional therapy. RESULTS: In unadjusted analyses, prior interventional BPH therapy was associated with higher risks of postoperative urinary retention (17.5% vs. 9.6%, p = 0.001) and new-onset urinary incontinence (39.9% vs. 19.4%, p > 0.001) compared with no prior therapy. Interventional BPH therapy was not correlated with the risk of developing a rectourethral fistula (p = 0.84) or new-onset erectile dysfunction (ED) at 12 months (p = 0.08) following surgery. On multivariable regression, prior interventional BPH therapy was associated with increased risk of urinary retention (OR 1.9, 95%, p = 0.015) and new-onset urinary incontinence (OR 2.13, p < 0.001). The estimated 5 years Kaplan-Meier survival analysis showed no statistically significant difference (p = 0.3) in biochemical progression free survival between those who underwent interventional BPH therapy compared with those who did not. Local disease recurrence assessed by post cryoablation positive for-cause prostate biopsy showed no significant difference between the two groups (25.4% vs. 28.7%, p = 0.59). CONCLUSIONS: Prior interventional BPH therapy did not affect the oncologic outcomes nor did it increase the risk of rectourethral fistula or ED in sexually performing patients prior to cryosurgery. Prior interventional BPH therapy was associated with increased risk of urinary retention and incontinence after primary whole-gland prostate cryoablation for prostate cancer.

The nomogram conundrum: a demonstration of why a prostate cancer risk model in Turkish men underestimates prostate cancer risk in the USA.

PURPOSE: The utility of a nomogram is based on the patient population it is designed for-and their inherent properties and biases. Our aim was to demonstrate the variability in predictive model accuracy and utility between different populations. METHODS: Our model is based on 761 men who underwent initial TRUS biopsy at a single institution in Turkey. Patients were included if they had at least 10 cores on biopsy and PSA level <20 ng/ml. Multivariable logistic regression models were used to develop a new nomogram. External validity was tested with two different cohorts one from another institution in Turkey (N = 136) and cohort from USA (N = 2242). RESULTS: Prostate cancer (PCa) and high-grade PCa was diagnosed in 249/761 (32.7 %) and 101/761 (13.3 %) patients from Ankara, Turkey, respectively. Predictors of PCa were age (p < 0.0001, OR 2.11), PSA (p = 0.044, OR 1.44), PV (p < 0.0001, OR 0.38), %fPSA (p = 0.016, OR 0.72), and abnormal DRE (p < 0.0001, OR 2.05). The predictive accuracy (c-index) of our nomogram was 73 %. C-indices of 71 and 70 % were recorded in external validation cohorts from Turkey and the USA, respectively. Virtually ideal calibration was recorded for the internal validated predictive model, and good calibration was recorded when applied to the Istanbul cohort. However, the model/nomogram underestimates PCa risk in the US cohort. CONCLUSION: This is the first nomogram predicting the risk of PCa at initial biopsy in a Turkish population and provides a good risk estimation tool with good predictive accuracy and calibration in the Turkish populations. However, our study demonstrates the poor transferability of predictive tools to widely different populations.

Prediction of prostate cancer to urethra distance by a pretreatment nomogram: urethral thermoprotection implication in cryoablation.

INTRODUCTION: Cryoablation is a treatment option for prostate cancer (PCa) patients. A urethral warming catheter is placed to protect the prostatic urethra from cryo-injury. Thus tissue within certain depth beneath the urethral mucosa, including PCa in that zone, is not cryoablated. Preoperative predictors of PCa-to-urethra distance are important for urologists and patients to decide if undergoing cryoablation. METHODS: A total of 267 consecutive radical prostatectomy specimens were reviewed by a pathologist and the shortest PCa-to-urethra distance was recorded as 0 (PCa at urethra), 0.1-1 mm, 1.1-2 mm, 2.1-3 mm, 3.1-4 mm, 4.1-5 mm and >5 mm. Preoperative serum PSA (iPSA) and prostate biopsy (Bx) parameters such as highest Bx Gleason score (BxGS), number of positive cores, highest percentage of PCa/cores, bilateral disease, perineural invasion (PNI) and PCa location were also recorded. The PCa-to-urethra distance subdivided into two (3 and >3 mm) and all seven categories was correlated with iPSA and Bx parameters. Logistic and linear regression were used to analyze the data. RESULTS: Patients' median age and iPSA were 59 years and 5.28 ng ml(-1), respectively. PCa-to-urethra distance was <5 mm in 163 (61%) patients, 3 mm in 48% of patients. Significant univariate associations were found between shorter PCa-to-urethra distance and increasing iPSA (P<0.0001), BxGS (P=0.0016), number of positive cores (P< 0.0001), highest percentage of PCa/cores (P< 0.0001), bilateral disease (P=0.0003), PNI (P=0.01) and PCa detected in biopsies from apex (P< 0.0001), base (P=0.001) and base/medial base (P= 0.0006). In multivariate analysis, the iPSA (log), highest percentage of PCa/cores and PCa detected in the apex were significantly associated (P<0.0001) with both versions of PCa-to-urethra distance. CONCLUSIONS: Increasing iPSA, highest percentage of PCa/cores and PCa detected in the apex were associated with a shorter PCa-to-urethra distance. Inclusion of these preoperative parameters in a nomogram will help estimating the PCa-to-urethra distance and identifying better candidates for cryoablation.

Evaluating the PCPT risk calculator in ten international biopsy cohorts: results from the Prostate Biopsy Collaborative Group.

OBJECTIVES: To evaluate the discrimination, calibration, and net benefit performance of the Prostate Cancer Prevention Trial Risk Calculator (PCPTRC) across five European randomized study of screening for prostate cancer (ERSPC), 1 United Kingdom, 1 Austrian, and 3 US biopsy cohorts. METHODS: PCPTRC risks were calculated for 25,733 biopsies using prostate-specific antigen (PSA), digital rectal examination, family history, history of prior biopsy, and imputation for missing covariates. Predictions were evaluated using the areas underneath the receiver operating characteristic curves (AUC), discrimination slopes, chi-square tests of goodness of fit, and net benefit decision curves. RESULTS: AUCs of the PCPTRC ranged from a low of 56% in the ERSPC Goeteborg Rounds 2-6 cohort to a high of 72% in the ERSPC Goeteborg Round 1 cohort and were statistically significantly higher than that of PSA in 6 out of the 10 cohorts. The PCPTRC was well calibrated in the SABOR, Tyrol, and Durham cohorts. There was limited to no net benefit to using the PCPTRC for biopsy referral compared to biopsying all or no men in all five ERSPC cohorts and benefit within a limited range of risk thresholds in all other cohorts. CONCLUSIONS: External validation of the PCPTRC across ten cohorts revealed varying degree of success highly dependent on the cohort, most likely due to different criteria for and work-up before biopsy. Future validation studies of new calculators for prostate cancer should acknowledge the potential impact of the specific cohort studied when reporting successful versus failed validation.

Routine perioperative chemotherapy instillation with initial bladder tumor resection: a reconsideration of economic benefits.

BACKGROUND: Level-1 evidence has demonstrated decreased recurrence of low-grade bladder tumors when initial transurethral resection (TUR) is followed by perioperative instillation (PI) of chemotherapy. A meta-analysis determined that the number needed to treat (NNT) was 8.5 patients to prevent 1 recurrence. No benefit was demonstrated for tumors classified as T0, tumor in situ, or T2; thus, patients with those tumors were excluded from the analysis, which potentially may have resulted in underestimating the true NNT. Economic benefits were suggested, but cost calculations were not presented. The objectives of the current analysis were to recalculate the NNT considering patients who previously were excluded and to examine the economic implications based on various management alternatives for tumor recurrence. METHODS: For each study that was included in the current meta-analysis, the number of patients excluded because of 'inappropriate' pathology results was determined. A potentially more accurate NNT was calculated, and pertinent Medicare reimbursements were obtained to estimate costs. RESULTS: The added cost for 8.5 patients who underwent inpatient TUR to receive PI was $1711. Inpatient TUR ($7025) was extremely costly compared with hospital outpatient TUR ($2666), ambulatory surgery center TUR ($2113), and physician office fulguration ($1167). Although the inclusion of patients who previously were excluded resulted in a recalculated NNT of 9.6 patients, the authors used a more conservative NNT if 8.5 patients to estimate the economic impact of the 'best-case scenario.' CONCLUSIONS: Routine PI significantly lowered the overall cost if recurrences were managed in the inpatient setting, but these benefits were offset mostly or completely by outpatient management in the United States. Thus, the authors concluded that the decision to use routine PI of chemotherapy should be based on clinical effects and not on presumed economic benefits.