Category: Latest Articles

Novel syphon ureteral access sheath has potential to improve renal pressures and irrigant flow

September 8, 2021/by

Abstract

Objective

This paper describes a novel syphoning ureteral access sheath (UAS) intended for use during flexible uretero-renoscopy (URS). We aimed to assess if in vitro it could reduce intrarenal pressure (IRP) and increase irrigation flow compared to traditional UAS.

Methods

A validated phantom kidney with fiber optic pressure sensing capabilities was used to assess IRP. Standardized 80cm H20 irrigation via a ureterorenoscope was instilled through a traditional (11/13 Fr and 12/14 Fr) UAS and compared to the novel 11/13Fr syphoning UAS. Measured minute volume, calculated hourly flow volume and steady state IRP were compared.

Results

The traditional 11/13 Fr and 12/14 Fr UAS has statistically poorer irrigation flow compared to the novel syphoning UAS of 19,3 vs 29,3ml/min (p=0.0004) and 22,7 vs 29,3ml/min (p=0.0021) respectively. The steady state IRP were 20mmHg for the traditional 11/13Fr and 13mmHg for the 12/14Fr compared to 0mmHg for the novel UAS.

Conclusion

The described novel UAS is different from traditional devices by incorporating a syphon mechanism. Our in vitro assessment demonstrates that the novel UAS holds clinical potential to reduce IRP while allowing a significant increase in irrigant flow compared to larger diameter traditional UAS.

Outcomes of Freehand Transperineal Prostate Biopsy with Omission of Antibiotic Prophylaxis

September 7, 2021/by

Abstract

Objective

To assess the utility of antimicrobial prophylaxis when performing freehand systematic transperineal biopsy.

Patients and Methods

From 1/2012 to 2/2020, freehand transperineal prostate biopsy via angiocatheters or the PrecisionPoint Transperineal Access System was performed on consecutive men with clinical suspicion of prostate cancer or confirmed prostate cancer. Biopsies were performed by a single urologist (developer of the PrecisionPoint system). Clinical data was collected retrospectively. Pre-procedural antibiotics were given to all patients through September 6th, 2016. After this date, antibiotics were omitted from those without risk factors (chronic catherization, concurrent endoscopic procedure, history of sepsis after transrectal (TR) biopsy, history of TR biopsy within the last year, prosthetic joints/heart valves). Patients were assessed one week after biopsy for symptoms, Emergency Department visits, and hospital admissions. Patients who received antimicrobial prophylaxis were compared to those who did not and infectious complications were analyzed. Additionally, oncologic outcomes are reported.

Results

988 biopsies (median PSA 7.7 ng/ml) were included in the analysis on 756 men. 538 biopsies (54.4%) received prophylaxis and 450 (48.6%) did not receive prophylaxis. There was a statistical difference in the median age (67 vs 69 years, p < 0.001), abnormal DRE (13% vs 5%, p < 0.001), and history of mpMRI (15% vs 31%, p < 0.001) between the prophylaxis and no prophylaxis cohorts, respectively. There were no documented complications in those who received antibiotics. Within the no prophylaxis cohort, there were three (0.66%) complications (p = 0.09). Two (0.44%) patients had UTIs and one (0.22%) patient experienced post-procedural urinary retention. No patients required hospital admission or ED visit. Clinically significant cancer was detected in 152 (40.0%) and 64 (39.0%) men on initial biopsy and prior negative biopsy, respectively.

Conclusions

This data suggests that antimicrobial prophylaxis may be safely omitted in selected patients when utilizing the freehand transperineal approach.

Urine dna for monitoring chemoradiotherapy response in muscle‐invasive bladder cancer: A pilot study

September 7, 2021/by

Abstract

Objective

To assess the utility of antimicrobial prophylaxis when performing freehand systematic transperineal biopsy.

Patients and Methods

From 1/2012 to 2/2020, freehand transperineal prostate biopsy via angiocatheters or the PrecisionPoint Transperineal Access System was performed on consecutive men with clinical suspicion of prostate cancer or confirmed prostate cancer. Biopsies were performed by a single urologist (developer of the PrecisionPoint system). Clinical data was collected retrospectively. Pre-procedural antibiotics were given to all patients through September 6th, 2016. After this date, antibiotics were omitted from those without risk factors (chronic catherization, concurrent endoscopic procedure, history of sepsis after transrectal (TR) biopsy, history of TR biopsy within the last year, prosthetic joints/heart valves). Patients were assessed one week after biopsy for symptoms, Emergency Department visits, and hospital admissions. Patients who received antimicrobial prophylaxis were compared to those who did not and infectious complications were analyzed. Additionally, oncologic outcomes are reported.

Results

988 biopsies (median PSA 7.7 ng/ml) were included in the analysis on 756 men. 538 biopsies (54.4%) received prophylaxis and 450 (48.6%) did not receive prophylaxis. There was a statistical difference in the median age (67 vs 69 years, p < 0.001), abnormal DRE (13% vs 5%, p < 0.001), and history of mpMRI (15% vs 31%, p < 0.001) between the prophylaxis and no prophylaxis cohorts, respectively. There were no documented complications in those who received antibiotics. Within the no prophylaxis cohort, there were three (0.66%) complications (p = 0.09). Two (0.44%) patients had UTIs and one (0.22%) patient experienced post-procedural urinary retention. No patients required hospital admission or ED visit. Clinically significant cancer was detected in 152 (40.0%) and 64 (39.0%) men on initial biopsy and prior negative biopsy, respectively.

Conclusions

This data suggests that antimicrobial prophylaxis may be safely omitted in selected patients when utilizing the freehand transperineal approach.

Learning Curve Analysis of Single‐Port Robot‐Assisted Extraperitoneal Prostatectomy Using the CUSUM Method

September 6, 2021/by

Abstract

Single-port (SP) was recently implemented as an alternative robotic system for extraperitoneal radical prostatectomy (EPP). The primary aim of this study is to characterize the learning curve (LC) for the SP-EPP for an experienced multi-port (MP) robotic surgeon. All consecutive SP-EPP cases (N=150) performed by a single surgeon from initial experience in a high-volume tertiary care center were prospectively included. The cumulative sum Method (CUSUM) was used retrospectively to create the LCs for SP-EPP surgery based on several outcomes used to gauge the surgeon’s performance relative to those previously obtained with the current gold standard (MP-Robot Assisted Radical Prostatectomy (MP-RALP);N=80). The evaluation of a surgical transition from MP to SP prostatectomy analyzed with the Statistical Process Control and the CUSUM method revealed a smooth and safe LC divided into four phases of 30-40 cases and a decrease of surgical time, blood loss and postoperative complication rate after the first learning phase.

Natural history of small asymptomatic kidney and residual stones over a long‐term follow‐up: systematic review over 25 years

September 6, 2021/by

Abstract

Single-port (SP) was recently implemented as an alternative robotic system for extraperitoneal radical prostatectomy (EPP). The primary aim of this study is to characterize the learning curve (LC) for the SP-EPP for an experienced multi-port (MP) robotic surgeon. All consecutive SP-EPP cases (N=150) performed by a single surgeon from initial experience in a high-volume tertiary care center were prospectively included. The cumulative sum Method (CUSUM) was used retrospectively to create the LCs for SP-EPP surgery based on several outcomes used to gauge the surgeon’s performance relative to those previously obtained with the current gold standard (MP-Robot Assisted Radical Prostatectomy (MP-RALP);N=80). The evaluation of a surgical transition from MP to SP prostatectomy analyzed with the Statistical Process Control and the CUSUM method revealed a smooth and safe LC divided into four phases of 30-40 cases and a decrease of surgical time, blood loss and postoperative complication rate after the first learning phase.

Adjuvant therapy in patients with sarcomatoid RCC: Post hoc analysis from ECOG‐ACRIN E2805

September 4, 2021/by

Abstract

Objectives

To study the effects on adjuvant therapy in patients with sarcomatoid RCC enrolled in the randomized phase 3 clinical trial E2805.

Materials and Methods

The original trial (E2805) is a randomized, double-blinded phase 3 clinical trial comparing outcomes in 1,943 patients with RCC accrued between 2006 and 2010, and treated with up to 1 year of adjuvant placebo, sunitinib, or sorafenib. The current study analyses the cohort of patients with sRCC that participated in E2805.

Results

171 patients (8.8%) had sarcomatoid features. 52 patients received sunitinib, 58 received sorafenib, and 61 received placebo. Most patients were pT3-4 (71.1%, 63.7%, 70.5%, respectively) and 17.3%, 19.0%, 27.9% had pathologically positive lymph nodes. 59.6%, 62.1%, and 62.3% of the patients were UCLA UISS very-high risk. Forty-nine percent of patients with subsequent development of metastatic disease recurred in the lung, followed by 30% in the lymph nodes, and 13% in the liver. There was a high local recurrence rate in the renal bed (16%, 29%, and 18%, respectively). Five-year DFS rates were 33.6%, 36.0%, and 27.8%, for sunitinib, sorafenib and placebo, respectively; [HR (95% CI) 0.74(0.45–1.20) for sunitinib versus placebo, and HR 0.82(0.53–1.28) for sorafenib versus placebo].

Conclusions

Adjuvant therapy with sunitinib or sorafenib did not show an improvement of DFS or OS in patients with RCC with sarcomatoid features.

Robot Assisted Salvage Seminal Vesicle Excision for isolated recurrence after Low Dose Rate Prostate Brachytherapy

August 30, 2021/by

Objective

To assess the incidence of testicular cancer in trans women (male sex assigned at birth, female gender identity) using gender-affirming hormonal treatment.

Patients and Methods

Data of trans women starting hormonal treatment at our gender identity clinic between 1972 and 2017 were linked to the national pathology database to obtain testicular cancer diagnoses. The standardised incidence ratio (SIR) was calculated using the number of observed testicular cancer cases in our cohort and the number of expected cases based on age-specific Dutch incidence rates. Subgroup analyses were performed in testicular tissues sent for histopathological analysis at the time of bilateral orchidectomy, and when follow-up exceeded 5 years.

Results

The cohort consisted of 3026 trans women with a median follow-up time of 2.3 interquartile range (IQR) (1.6–3.7) years. Two testicular cancer cases were identified whilst 2.4 cases were expected (SIR 0.8, 95% confidence interval 0.1–2.8). In addition, one testicular cancer case was encountered in an orchidectomy specimen (0.1%). In the 523 trans women with a follow-up time of >5 years (median [IQR] 8.9 [6.4–13.9] years), no testicular cancer was observed.

Conclusion

Testicular cancer risk in trans women is similar to the risk in cis men. The testicular cancer cases occurred within the first 5 years after commencing hormonal treatment, and the percentage of cases encountered at the time of bilateral orchidectomy was low. As no testicular cancer was observed in trans women with a long follow-up period, long-term hormonal treatment does not seem to increase testicular cancer risk.

Update from the Canadian Urological Association

August 30, 2021/by

Objective

To assess the activity and safety of sequential lutetium-177 (177Lu)-PSMA-617 and docetaxel vs docetaxel on a background of androgen deprivation therapy (ADT) in men with de novo metastatic hormone-naïve prostate cancer (mHNPC).

Patients and Methods

UpFrontPSMA (NCT04343885) is an open-label, randomized, multicentre, phase 2 trial, recruiting 140 patients at 12 Australian centres. Key eligibility criteria include: prostate cancer with a histological diagnosis within 12 weeks of screening commencement; prostate-specific antigen (PSA) >10 ng/mL at diagnosis; ≤4 weeks on ADT; evidence of metastatic disease on computed tomography (CT) and/or bone scan; high-volume prostate-specific membrane antigen (PSMA)-avid disease with a maximum standardized uptake value >15; and absence of extensive discordant fluorodeoxyglcuose (FDG)-positive, PSMA-negative disease. 68Ga-PSMA-11 and 18F-FDG positron-emission tomography (PET)/CT undergo central review to determine eligibility. Patients are randomized 1:1 to experimental treatment, Arm A (177Lu-PSMA-617 7.5GBq q6w × 2 cycles followed by docetaxel 75 mg/m2 q3w × 6 cycles), or standard-of-care treatment, Arm B (docetaxel 75 mg/m2 q3w × 6 cycles). All patients receive continuous ADT. Patients are stratified based on disease volume on conventional imaging and duration of ADT at time of registration. The primary endpoint is the proportion of patients with undetectable PSA (≤0.2 ng/L) at 12 months after study treatment commencement. Secondary endpoints include safety, time to castration resistance, overall survival, PSA and radiographic progression-free survival, objective tumour response rate, early PSMA PET response, health-related quality of life, and frequency and severity of adverse events. Enrolment commenced in April 2020.

Results and Conclusions

The results of this trial will generate data on the activity and safety of 177Lu-PSMA-617 in men with de novo mHNPC in a randomized phase 2 design.

Case of the month from San Raffaele Hospital, Milan, Italy: Pushing the limits of simultaneous bilateral endoscopic surgery for renal stones

August 30, 2021/by

Objective

To assess the activity and safety of sequential lutetium-177 (177Lu)-PSMA-617 and docetaxel vs docetaxel on a background of androgen deprivation therapy (ADT) in men with de novo metastatic hormone-naïve prostate cancer (mHNPC).

Patients and Methods

UpFrontPSMA (NCT04343885) is an open-label, randomized, multicentre, phase 2 trial, recruiting 140 patients at 12 Australian centres. Key eligibility criteria include: prostate cancer with a histological diagnosis within 12 weeks of screening commencement; prostate-specific antigen (PSA) >10 ng/mL at diagnosis; ≤4 weeks on ADT; evidence of metastatic disease on computed tomography (CT) and/or bone scan; high-volume prostate-specific membrane antigen (PSMA)-avid disease with a maximum standardized uptake value >15; and absence of extensive discordant fluorodeoxyglcuose (FDG)-positive, PSMA-negative disease. 68Ga-PSMA-11 and 18F-FDG positron-emission tomography (PET)/CT undergo central review to determine eligibility. Patients are randomized 1:1 to experimental treatment, Arm A (177Lu-PSMA-617 7.5GBq q6w × 2 cycles followed by docetaxel 75 mg/m2 q3w × 6 cycles), or standard-of-care treatment, Arm B (docetaxel 75 mg/m2 q3w × 6 cycles). All patients receive continuous ADT. Patients are stratified based on disease volume on conventional imaging and duration of ADT at time of registration. The primary endpoint is the proportion of patients with undetectable PSA (≤0.2 ng/L) at 12 months after study treatment commencement. Secondary endpoints include safety, time to castration resistance, overall survival, PSA and radiographic progression-free survival, objective tumour response rate, early PSMA PET response, health-related quality of life, and frequency and severity of adverse events. Enrolment commenced in April 2020.

Results and Conclusions

The results of this trial will generate data on the activity and safety of 177Lu-PSMA-617 in men with de novo mHNPC in a randomized phase 2 design.

World News

August 29, 2021/by Admin

Objective

To assess the activity and safety of sequential lutetium-177 (177Lu)-PSMA-617 and docetaxel vs docetaxel on a background of androgen deprivation therapy (ADT) in men with de novo metastatic hormone-naïve prostate cancer (mHNPC).

Patients and Methods

UpFrontPSMA (NCT04343885) is an open-label, randomized, multicentre, phase 2 trial, recruiting 140 patients at 12 Australian centres. Key eligibility criteria include: prostate cancer with a histological diagnosis within 12 weeks of screening commencement; prostate-specific antigen (PSA) >10 ng/mL at diagnosis; ≤4 weeks on ADT; evidence of metastatic disease on computed tomography (CT) and/or bone scan; high-volume prostate-specific membrane antigen (PSMA)-avid disease with a maximum standardized uptake value >15; and absence of extensive discordant fluorodeoxyglcuose (FDG)-positive, PSMA-negative disease. 68Ga-PSMA-11 and 18F-FDG positron-emission tomography (PET)/CT undergo central review to determine eligibility. Patients are randomized 1:1 to experimental treatment, Arm A (177Lu-PSMA-617 7.5GBq q6w × 2 cycles followed by docetaxel 75 mg/m2 q3w × 6 cycles), or standard-of-care treatment, Arm B (docetaxel 75 mg/m2 q3w × 6 cycles). All patients receive continuous ADT. Patients are stratified based on disease volume on conventional imaging and duration of ADT at time of registration. The primary endpoint is the proportion of patients with undetectable PSA (≤0.2 ng/L) at 12 months after study treatment commencement. Secondary endpoints include safety, time to castration resistance, overall survival, PSA and radiographic progression-free survival, objective tumour response rate, early PSMA PET response, health-related quality of life, and frequency and severity of adverse events. Enrolment commenced in April 2020.

Results and Conclusions

The results of this trial will generate data on the activity and safety of 177Lu-PSMA-617 in men with de novo mHNPC in a randomized phase 2 design.