A 2-year prospective evaluation of the Prostate Health Index in guiding biopsy decisions in a large cohort.

OBJECTIVES: To prospectively evaluate how the Prostate Health Index (PHI) impacts on clinical decision in a real-life setting for men with a prostate-specific antigen (PSA) level between 4 and 10 ng/mL and normal digital rectal examination. PATIENTS AND METHODS: Since 2016, the PHI has been available at no cost to eligible men in all Hong Kong public hospitals. All eligible patients who received PHI testing in all public Urology units (n = 16) in Hong Kong between May 2016 and August 2017 were prospectively included and followed up. All included men had a PHI test, with its result and implications explained; the subsequent follow-up plan was then decided via shared decision-making with urologists. Patients were followed up for 2 years, with outcomes including prostate biopsy rates and biopsy findings analysed in relation to the initial PHI measurements. RESULTS: A total of 2828 patients were followed up for 2 years. The majority (82%) had PHI results in the lower risk range (score <35). Knowing the PHI findings, 83% of the patients with elevated PSA decided not to undergo biopsy. In all, 11% and 45% opted for biopsy in the PHI score <35 and ≥35 groups, respectively. The initial detection rate of International Society of Urological Pathology (ISUP) Grade Group (GG) ≥2 cancer was higher in the PHI score ≥35 group (23%) than in the PHI score <35 group (7.9%). Amongst patients with no initial positive biopsy findings, the subsequent positive biopsy rate for ISUP GG ≥2 cancer was higher in the PHI score ≥35 group (34%) than the PHI score <35 group (13%) with a median follow-up of 2.4 years. CONCLUSION: In a real-life setting, with the PHI incorporated into the routine clinical pathway, 83% of the patients with elevated PSA level decided not to undergo prostate biopsy. The PHI pathway also improved the high-grade prostate cancer detection rate when compared to PSA-driven strategies. Higher baseline PHI predicted subsequent biopsy outcome at 2 years. The PHI can serve as a tool to individualise biopsy decisions and frequency of follow-up visits.

Adverse metabolic consequences of androgen deprivation therapy (ADT) on Asian patients with prostate cancer: Primary results from the real-life experience of ADT in Asia (READT) study.

BACKGROUND: Androgen deprivation therapy (ADT) use in prostate cancer (PCa) has seen a rising trend. We investigated the relationship between ADT and adverse changes in metabolic parameters in an Asian population. METHODS: This is an international prospective multicenter single-arm cohort yielded from the real-life experience of ADT in Asia (READT) registry. Consecutive ADT-naïve patients diagnosed of PCa and started on ADT were prospectively recruited from 2016 and analyzed. Baseline patient characteristics, PCa disease status, and metabolic parameters were documented. Patients were followed up at 6-month interval for up to 5 years. Metabolic parameters including body weight, lipid profiles, and glycemic profiles were recorded and analyzed. RESULTS: 589 patients were eligible for analysis. ADT was associated with adverse glycemic profiles, being notable at 6 months upon ADT initiation and persisted beyond 1 year. Comparing to baseline, fasting glucose level and hemoglobin A1c level increased by 4.8% (p < 0.001) and 2.7% (p < 0.001), respectively. Triglycerides level was also elevated by 16.1% at 6th month and by 20.6% at 12th month compared to baseline (p < 0.001). Mean body weight was 1.09 kg above baseline at 18th month (p < 0.001). CONCLUSION: ADT was associated with adverse metabolic parameters in terms of glycemic profiles, lipid profiles, and body weight in the Asian population. These changes developed early in the treatment and can persist beyond the first year. Regular monitoring of the biochemical profiles during treatment is paramount in safeguarding the patients' metabolic health.

A systematic review on COVID-19: urological manifestations, viral RNA detection and special considerations in urological conditions.

PURPOSE AND OBJECTIVE: We performed a systematic review on COVID-19 and its potential urological manifestations. METHODS: A literature search was performed using combination of keywords (MeSH terms and free text words) relating to COVID-19, urology, faeces and stool on multiple databases. Primary outcomes were the urological manifestations of COVID-19, and SARS-CoV-2 viral RNA detection in urine and stool samples. Meta-analyses were performed when there were two or more studies reporting on the same outcome. Special considerations in urological conditions that were relevant in the pandemic of COVID-19 were reported in a narrative manner. RESULTS: There were a total of 21 studies with 3714 COVID-19 patients, and urinary symptoms were absent in all of them. In patients with COVID-19, 7.58% (95% CI 3.30-13.54%) developed acute kidney injury with a mortality rate of 93.27% (95% CI 81.46-100%) amongst them. 5.74% (95% CI 2.88-9.44%) of COVID-19 patients had positive viral RNA in urine samples, but the duration of viral shedding in urine was unknown. 65.82% (95% CI 45.71-83.51%) of COVID-19 patients had positive viral RNA in stool samples, which were detected from 2 to 47 days from symptom onset. 31.6% of renal transplant recipients with COVID-19 required non-invasive ventilation, and the overall mortality rate was 15.4%. CONCLUSIONS: Acute kidney injury leading to mortality is common amongst COVID-19 patients, likely as a result of direct viral toxicity. Viral RNA positivity was detected in both urine and stool samples, so precautions are needed when we perform transurethral or transrectal procedures.

Clinical and Surgical Assistance in Prostate Cancer during the COVID-19 Pandemic: Implementation of assistance protocols.

PURPOSE: Propose an approach of prostate cancer (PCa) patients during COVID-19 pandemic. MATERIAL AND METHODS: We conducted a review of current literature related to surgical and clinical management of patients during COVID-19 crisis paying special attention to oncological ones and especially those suffering from PCa. Based on these publications and current urological guidelines, a manual to manage PCa patients is suggested. RESULTS: Patients suffering from cancer are likely to develop serious complications from COVID-19 disease together with an increased risk of postoperative morbidity and mortality. Therefore, the management of oncological patients should be taken into special consideration and most of the treatments postponed. In case the procedure is not deferrable, it should be adapted to the current situation. While the shortest radiotherapy (RT) regimens should be applied, surgical procedures must undergo the following recommendations proposed by main surgical associations. PCa prognosis is generally favourable and therefore one can safely delay most of the biopsies up to 6 months without interfering with survival outcomes in the vast majority of cases. In the same way, most of the localised PCa patients are suitable for active surveillance (AS) or hormonal therapy until local definitive treatment could be reconsidered. In metastatic as well as castration resistant PCa stages, adding androgen receptor targeted agents (abiraterone, apalutamide, darolutamide or enzalutamide) to androgen-deprivation therapy (ADT) could be considered in high risk patients. On the contrary, chemotherapy, immunotherapy and Radium-223 must be avoided with regard to the consequence of hematologic toxicity and risk of COVID-19 infection because of immunodepression. CONCLUSIONS: Most of the biopsies should be delayed while AS is advised in those patients with low risk PCa. ADT allows us to defer definitive local treatment in many cases of intermediate and high risk PCa. In regard to metastatic and castration resistant PCa, combination therapies with abiraterone, apalutamide, darolutamide or enzalutamide could be considered. Chemotherapy, Radium-223 and immunotherapy are discouraged.

Effect of Stepwise Voltage Escalation on Treatment Outcomes following Extracorporeal Shock Wave Lithotripsy of Renal Calculi: A Prospective Randomized Study.

PURPOSE: In this study we assessed the effects of a ramping protocol in patients undergoing extracorporeal shock wave lithotripsy of renal stones. MATERIALS AND METHODS: In this prospective study patients with renal stones were randomized to receive shock wave lithotripsy delivered using a ramping protocol in group 1 (first 1,000 shocks at energy level 5 followed by 1,000 shocks at energy level 6 and 1,000 final shocks at energy level 7) and a fixed voltage protocol in group 2 (all 3,000 shocks at energy level 7). Treatment was administered using a Modulith® SLX-F2. The primary outcome was treatment success 12 weeks after a single shock wave lithotripsy session, defined as lack of a stone or a less than 4 mm stone fragment on computerized tomography. Other outcomes included the stone-free rate and the perinephric hematoma incidence. RESULTS: A total of 300 patients (150 per group) were recruited between February 2016 and June 2018. The 2 groups did not differ in baseline parameters. Group 1 received 14.8% lower energy than group 2, which was significant (p <0.001). The treatment success rate in groups 1 and 2 was 67.8% and 73.6%, respectively, which did not statistically differ (group 1 crude OR 0.753, 95% CI 0.456-1.244, p=0.268). The stone-free rate in groups 1 and 2 was 36.6% and 41.9%, respectively, which did not differ statistically between the groups. However, in groups 1 and 2 perinephric hematoma developed in 23.8% and 43.8% of patients, respectively, which was a statistically significant difference (p <0.001). CONCLUSIONS: The fixed voltage shock wave lithotripsy and ramping protocols provided similar treatment success rates for renal stones. However, the ramping protocol reduced the incidence of perinephric hematoma after shock wave lithotripsy.

The cardiovascular risk factors in men with lower urinary tract symptoms.

OBJECTIVE: It has been hypothesized that endothelial dysfunction and pelvic atherosclerosis may contribute to lower urinary tract symptoms (LUTS). We assessed the relationship between cardiovascular risk factors and LUTS severity in male patients presented to urology clinic. METHODS: It is a cross-sectional study on patients who presented between 2013 and 2015 with LUTS. A total of 1176 male patients were encountered, and 966 were included for analysis after excluding patients with urinary tract malignancy, urethral stricture, bladder stone and history of urinary tract surgery. Cardiovascular risk factors including components of Framingham risk score, body mass index, uroflowmetry, International Prostate Symptoms Score, fasting blood glucose and serum prostate-specific antigen (PSA) were assessed. Correlation between Framingham risk score, cardiovascular risk factors and severity of LUTS was investigated. RESULTS: Multinomial logistic regression analysis showed that severe LUTS significantly associated with Framingham score (P = 0.008) and its components of total cholesterol (OR = 1.318; P = 0.010) and age (OR = 1.032; P = 0.006) compare with mild symptoms. Framingham risk score was found to correlate with storage symptoms (CC = 0.083; P < 0.0001) but not voiding symptoms (CC = - 0.029; P = 0.185). CONCLUSIONS: Severity of LUTS and storage symptom significantly increases Framingham risk score, particularly with the components of total cholesterol level and age.

Robot-assisted single-port radical prostatectomy: A phase 1 clinical study.

OBJECTIVE: To investigate the safety and feasibility of robot-assisted single-port radical prostatectomy using the da Vinci single-port surgical system. METHODS: This was a prospective phase 1 clinical study of prostate cancer patients undergoing robot-assisted single-port radical prostatectomy using the da Vinci single-port surgical system. Primary outcome measures included the conversion rate and 30-day complications after surgery. Secondary outcome measures included operative time, blood loss, hospital stay, duration of catheterization, final pathological outcomes and number of lymph nodes yielded at pelvic lymphadenectomy. RESULTS: From February to August 2017, 20 patients were included in the present study. The mean age was 67.7 ± 6.0 years. The mean preoperative prostate-specific antigen level was 15.3 ± 11.3 ng/mL, and the mean prostate size was 36.6 ± 15.5 mL. Preoperatively, 12 (60%) patients had a Gleason score of 6, four (20%) had a Gleason score of 7 and four (20%) had a Gleason score of 8-10. The mean operative time was 208.9 ± 35.2 min, and the mean blood loss was 296.3 ± 220.7 mL. None of the patients required conversion. The mean hospital stay was 5.0 ± 1.7 days. Among the patients, six (15%) had T2a disease, one (5%) had T2b disease, seven (35%) had T2c disease and nine (45%) had T3a disease on final pathology. A mean number of 8.3 ± 7.1 lymph nodes were yielded at pelvic lymphadenectomy. There were no intraoperative complications. The observed postoperative complications were Clavien grade I-II, and all resolved with conservative management. CONCLUSION: Robot-assisted single-port radical prostatectomy using the da Vinci surgical system is safe and technically feasible.

Comparison of Detrusor Muscle Sampling Rate in Monopolar and Bipolar Transurethral Resection of Bladder Tumor: A Randomized Trial.

PURPOSE: Our aim was to investigate the detrusor muscle sampling rate after monopolar versus bipolar transurethral resection of bladder tumor (TURBT). METHODS: This was a single-center, prospective, randomized, phase III trial on monopolar versus bipolar TURBT. Baseline patient characteristics, disease characteristics and perioperative outcomes were compared, with the primary outcome being the detrusor muscle sampling rate in the TURBT specimen. Multivariate logistic regression analyses on detrusor muscle sampling were performed. RESULTS: From May 2012 to December 2015, a total of 160 patients with similar baseline characteristics were randomized to receive monopolar or bipolar TURBT. Fewer patients in the bipolar TURBT group required postoperative irrigation than patients in the monopolar TURBT group (18.7 vs. 43%; p = 0.001). In the whole cohort, no significant difference in the detrusor muscle sampling rates was observed between the bipolar and monopolar TURBT groups (77.3 vs. 63.3%; p = 0.057). In patients with urothelial carcinoma, bipolar TURBT achieved a higher detrusor muscle sampling rate than monopolar TURBT (84.6 vs. 67.7%; p = 0.025). On multivariate analyses, bipolar TURBT (odds ratio [OR] 2.23, 95% confidence interval [CI] 1.03-4.81; p = 0.042) and larger tumor size (OR 1.04, 95% CI 1.01-1.08; p = 0.022) were significantly associated with detrusor muscle sampling in the whole cohort. In addition, bipolar TURBT (OR 2.88, 95% CI 1.10-7.53; p = 0.031), larger tumor size (OR 1.05, 95% CI 1.01-1.10; p = 0.035), and female sex (OR 3.25, 95% CI 1.10-9.59; p = 0.033) were significantly associated with detrusor muscle sampling in patients with urothelial carcinoma. CONCLUSIONS: There was a trend towards a superior detrusor muscle sampling rate after bipolar TURBT. Further studies are needed to determine its implications on disease recurrence and progression.

Case-Control Study of Intra-arterial Verapamil for Intraprostatic Anastomoses to Extraprostatic Arteries in Prostatic Artery Embolization for Benign Prostatic Hypertrophy.

PURPOSE: It is hypothesized that intra-arterial administration of verapamil is a safe and effective way to reverse the flow in intraprostatic anastomoses to extraprostatic arteries without compromising treatment outcomes in prostatic artery embolization (PAE) for benign prostatic hypertrophy (BPH). MATERIALS AND METHODS: A prospective study of 62 prostate sides in 31 consecutive patients (median age, 66 y; range, 60-71 y) with symptomatic BPH was undertaken. Median prostate volume was 72.4 mL (range, 48.8-85.8 mL), median International Prostate Symptom Score was 21 (range, 15-23), and median urine peak flow rate was 4 mL/s (range, 2-6 mL/s). The arterial anastomoses were classified as types I-III according to vascular morphology. Treatment safety was assessed in terms of adverse events and complications, and treatment effectiveness was assessed in terms of success rate of angiographic flow reversal. RESULTS: The PAE procedure was successfully completed in all 31 patients (100%). Adverse events in both groups were transient and mild and did not necessitate prolonged hospitalization. There was no clinical evidence of any significant nontarget ischemic complication in either group. Intraprostatic anastomosis was diagnosed in 19 of 31 patients (61.3%) and 22 of 62 prostate sides (35.5%). Success rates of verapamil treatment were 88.9% overall (20 of 22) and 100% (19 of 19) in type II and III anastomoses. There was no difference between the treatment group and the control group in clinical, urologic, and imaging outcomes of PAE. CONCLUSIONS: Intra-arterial verapamil treatment was probably safe and effective in causing flow reversal in type II and III intraprostatic anastomoses and in preventing ischemic complications in PAE for BPH without compromising PAE outcomes.

Prostate Health Index and %p2PSA Predict Aggressive Prostate Cancer Pathology in Chinese Patients Undergoing Radical Prostatectomy.

PURPOSE: To investigate the performance of prostate health index (PHI) and percentage prostate-specific antigen (PSA) isoform [-2]proPSA (%p2PSA) in predicting pathologic outcomes at radical prostatectomy (RP) in a Chinese population. METHODS: We performed a prospective study of 135 prostate cancer patients with RP. The accuracy of preoperative %p2PSA (= p2PSA/free PSA) and PHI [= (p2PSA/free PSA) × âˆšPSA] in predicting pathologic outcomes of RP including pT3 disease, pathologic Gleason score (pGS) ≥7, Gleason score (GS) upgrade at RP, tumor volume >0.5 ml, and Epstein criteria for significant tumor were calculated using multivariate analyses and area under the curve. The base model in multivariate analysis included age, PSA, abnormal digital rectal examination, and biopsy GS. RESULTS: PHI was significantly higher in patients with pT3 or pGS ≥ 7 (p < 0.001), pT3 disease (p = 0.001), pGS ≥ 7 (p < 0.001), GS upgrade (p < 0.001), tumor volume >0.5 ml (p < 0.001), and Epstein criteria for significant tumor (p = 0.001). %p2PSA was also significantly higher in all the above outcomes. The risk of pT3 or pGS ≥ 7 was 16.1 % for PHI < 35 and 60.8 % for PHI > 35 (sensitivity 84.2 %, specificity of 60.3 %), and the risk of tumor volume >0.5 ml was 25.5 % for PHI < 35 and 72.6 % for PHI > 35 (sensitivity 79.1 %, specificity 67.2 %). In multivariate analysis, adding %p2PSA or PHI to the base model significantly improved the accuracy (area under the curve) in predicting pT3 or pGS ≥ 7 (by 7.2-7.9 %), tumor volume >0.5 ml (by 10.3-12.8 %), and Epstein criteria for significant tumor (by 13.9-15.9 %). Net clinical benefit was observed in decision curve analyses for prediction of both tumor volume >0.5 ml, and pT3 or pGS ≥ 7. CONCLUSIONS: Both PHI and %p2PSA predict aggressive and significant pathologies in RP in Chinese men. This enabled identification of nonaggressive cancers for better counseling on active surveillance or treatment.

Urological malignancy in Hong Kong: the trend and the practice.

In Hong Kong, urological malignancy accounted for 9.55% of all the new cases of cancer in 2012. In the male population, prostate cancer was the third most commonly diagnosed cancer, and the fifth leading cause of cancer death. Age-standardized rate of prostate cancer incidence rose from 11.5 per 100 000 men in 1992 to 28.5 per 100 000 men in 2012. On the other hand, age-standardized rate of bladder cancer incidence dropped from 6.4 per 100 000 in 2003 to 3.0 per 100 000 in 2012. The incidence of kidney cancer remained stable in recent years, with an age-standardized rate of 4.8 per 100 000 in 2012. The introduction of the robotic surgical system has made robotic-assisted laparoscopic radical prostatectomy the most common mode of surgical treatment for prostate cancer in Hong Kong. Robotic-assisted laparoscopic radical cystectomy and robotic-assisted laparoscopic partial nephrectomy have been gaining popularity in the locality. Minimal-invasive surgical techniques as well as different systemic therapies have led to revolutionary changes in the urology community in Hong Kong. The existing territory-wide surveillance of cancer incidence and mortality trends continue to provide us with clues to aetiology and the effects of improved diagnostic and treatment techniques.

One-stop clinic for ketamine-associated uropathy: report on service delivery model, patients' characteristics and non-invasive investigations at baseline by a cross-sectional study in a prospective cohort of 318 teenagers and young adults.

OBJECTIVE: To describe a service delivery model and report the baseline characteristics of patients investigated by a non-invasive approach for ketamine-associated uropathy. PATIENTS AND METHODS: This was a cross-sectional study in a prospective cohort of patients who attended their first visit and underwent non-invasive investigations at a dedicated centre to treat ketamine-associated uropathy in Hong Kong from December 2011 to July 2013. Data on demographics, illicit ketamine use, symptoms scores and voiding function parameters at baseline were prospectively collected. Differences between active abusers and ex-abusers, and risk factors for the most symptomatic group were investigated by univariate and multivariate analysis. RESULTS: In all, 318 patients completed the non-invasive assessment at their first visit and were eligible for inclusion. In all, 174 were female and the mean (sd) age of the entire cohort was 24.4 (3.1) years. Patients had used ketamine for a mean (sd) period of 81 (36) months. The mean (sd) ketamine use per week was 18.5 (15.8) g. In all, 214 patients were active abusers while 104 were ex-abusers but had persistent lower urinary tract symptoms. The mean (sd) voided volume, bladder capacity, and bladder emptying efficiency were 111.5 (110) mL, 152.5 (126) mL and 73.3 (26.9)%, respectively. The ex-abusers had a lower symptom score (19.3 vs 24.1; P < 0.001), a larger voided volume (126 vs 85 mL; P < 0.001), and a larger bladder capacity (204.8 vs 126.7 mL; P < 0.001) compared with active abusers. Multivariate analysis found female gender was associated with a higher symptom score (odds ratio [OR] 2.39; 95% confidence interval [CI] 1.35-4.23; P = 0.003) and a smaller voided volume (OR 1.9; 95% CI 1.1-3.3; P = 0.02). Ketamine taken (g/week) was another risk factor for a higher symptom score (OR 1.03; 95% CI 1.01-1.05; P = 0.002). Status of ex-abuser was the only protective factor associated with fewer symptoms, larger voided volume and bladder capacity. CONCLUSIONS: An effective service model for recruiting patients with ketamine-associated uropathy is possible. With such a service model as a platform, further prospective studies are warranted to investigate the appropriate choice of treatment for this new clinical entity.

Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study.

OBJECTIVES: To investigate the role of low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction. METHODS: This was a double-blinded, single-center, prospective, randomized, placebo-controlled trial. After a 2-week phosphodiesterase type 5 inhibitor washout period, patients were assessed with Sexual Health Inventory for Men, International Index of Erectile Function-ED domain scores and Erection Hardness Score. Randomization into either the low-intensity extracorporeal shockwave therapy group or the sham group took place. After the 9-week treatment period, patients were followed up 4 weeks later. Follow-up assessment was in the form of International Index of Erectile Function-ED domain score and Erection Hardness Score. RESULTS: A total of 70 patients were recruited into the study, 58 patients completed the study. A total of 28 patients were randomized into the sham therapy arm, and 30 patients were randomized into the low-intensity extracorporeal shockwave therapy arm. There was no significant difference between these two groups in baseline International Index of Erectile Function-ED domain score and Erection Hardness Score. The mean International Index of Erectile Function-ED domain score of the low-intensity extracorporeal shockwave therapy arm and sham arm in week 13 were 17.8 ± 4.8 and 15.8 ± 6.1, respectively (P = 0.156). The mean Erection Hardness Scores in week 13 were 2.7 ± 0.5 and 2.4 ± 0.9, respectively (P = 0.163). When patients were stratified into different baseline Sexual Health Inventory for Men subgroups, the pre-intervention and post-intervention difference in low-intensity extracorporeal shockwave therapy was found to be significant in the subgroup with severe erectile dysfunction (low-intensity extracorporeal shockwave therapy International Index of Erectile Function-ED domain improvement: 10.1 ± 4.1 vs sham therapy International Index of Erectile Function-ED domain improvement: 3.2 ± 3.3; P = 0.003). CONCLUSION: The present trial shows the tolerability and clinical efficacy of low-intensity extracorporeal shockwave therapy in a subgroup of patients with erectile dysfunction.

High-intensity focused ultrasound strategies for treating prostate cancer.

ABSTRACT: Prostate cancer (PCa) is a significant health concern globally, necessitating effective treatment options. Typical treatment methods for early stage, particularly localized PCa, encompass radical procedures, such as radical prostatectomy (RP) and radiotherapy (RT), and nonradical focal therapy (FT). FT is a focused approach mainly used for treating small lesions limited to a specific zone of the prostate. Its objective is to achieve cancer control when minimizing damage to benign tissue. High-intensity focused ultrasound (HIFU) is one of the most used modalities in FT for the management of PCa. The progress in HIFU technology showcases continuous advancements, offering clinicians a variety of strategies to cater to diverse patient requirements. The advancements include the development of transrectal and transurethral HIFU machines that offer enhanced treatment distances, magnetic resonance imaging (MRI) fusion capabilities, real-time monitoring, and precise ablation. These improvements contribute to increased treatment effectiveness and better outcomes for patients. This narrative review aims to summarize the use of HIFU technology and its evolution, offering diverse options to clinicians, and explores the safety, effectiveness, and quality of different HIFU strategies, such as whole-gland ablation, hemigland ablation, and focal ablation. We conclude that nonwhole-gland HIFU offers similar cancer control with better short-term functional outcomes and fewer complications compared to whole-gland ablation. Combining HIFU with transurethral resection of the prostate (TURP) improves urinary function and reduces catheterization time. Focal ablation and hemigland ablation show promise in achieving cancer control when preserving continence and potency.

Patient Preference of Apalutamide Versus Enzalutamide for Recurrent or Metastatic Hormone-sensitive Prostate Cancer: An Open-label, Randomized, Crossover Trial.

BACKGROUND AND OBJECTIVE: Treatment preference regarding apalutamide versus enzalutamide in prostate cancer (PCa) and the factors influencing decisions are largely unknown. Our aim was to investigate the preference for apalutamide versus enzalutamide among prostate cancer patients and their physicians and caregivers, and factors influencing their decision. METHODS: This was a prospective, open-label, randomized, crossover trial. Patients with recurrence of localized PCa or with metastatic disease not considered as high-risk or high-volume and on continued androgen deprivation therapy were recruited. All subjects received a trial of two agents, apalutamide (A) and enzalutamide (E), for 12 wk each, with a 5-wk washout period in between. The sequencing of the drugs was randomized. The primary outcome was patient preference for one the drugs, assessed at the end of the study. Other outcomes included factors influencing patient preference, a comparison of side-effect profiles, and patients' quality of life (QoL). Physician and caregiver preferences for the drugs and factors affecting their choice were also assessed. KEY FINDINGS AND LIMITATIONS: A total of 74 patients met the eligibility criteria and were randomized to the A â†’ E or E â†’ A arm. Of these, 66 patients (89.1%; 32 A â†’ E, 34 E â†’ A) completed the study. Baseline characteristics were comparable between the two groups, and ∼90% of the patients had low-volume metastatic disease. After completion of both treatments for 12 wk each, the difference in preference for A over E was 17.8%, with similar trends for preference of A over E among physicians (18.2%) and caregivers (22.4%). Fewer side effect was the most critical factor influencing the preference of patients. Among the side effects, less fatigue was the benefit of A over E most frequently reported. No notable difference in QoL was observed between the two drugs. However, the study was terminated on interim analysis and the results might not be conclusive. CONCLUSIONS: There was a trend for preference of A over E among patients with predominantly low-volume recurrent or metastatic PCa and their physicians and caregivers. Fewer side effects was the most critical factor influencing their choice. PATIENT SUMMARY: Patients with low-volume recurrent or metastatic prostate cancer tended to prefer treatment with apalutamide over enzalutamide. Side effects were the most critical factor influencing treatment preference.

Effect of Focal Zone Size on Treatment Outcomes and Renal Injury Following Extracorporeal Shockwave Lithotripsy of Renal Calculi: A Prospective Randomized Study.

Background: The narrower focal zone (FZ) size of modern lithotripter was considered as one of the factors that resulted in suboptimal treatment result of extracorporeal shockwave lithotripsy (SWL). Therefore, we investigate the efficacy and safety of standard narrow or extended (FZ) sizes in SWL for patients with renal stones. Materials and Methods: In this prospective study conducted between April 2018 and October 2022, patients with renal stones were randomized to receive SWL with either standard or extended FZ. Treatment was delivered using a Modulith SLX-F2 lithotripter with a maximum of 3000 shocks at 1.5 Hz. The primary outcome was treatment success 12 weeks after a single SWL session, defined as the absence of a stone or stone fragment <4 mm on computed tomography. Secondary outcomes included the incidence of perinephric hematoma, stone-free rate (SFR), and changes in the urinary levels of acute renal injury markers. Results: A total of 320 patients were recruited, and 276 patients were randomized into the two groups. The two groups had similar baseline parameters. The treatment success rate was significantly better for standard FZ (74.3%) than the extended FZ group (59.3%) (p = 0.009). Standard FZ also had a significantly better SFR (Grade-A, 36.8% vs 23.0%, p = 0.013) and less pain after treatment. Both groups had similar perinephric hematoma formation rates, unplanned hospital admission rates, and changes in urinary acute renal injury markers. Conclusions: The standard narrow FZ has better treatment efficacy and similar safety compared with the extended FZ during SWL for renal stones. This clinical trial has been registered in the public domain (CCRBCTR) under trial number CUHK_CCRB00510.

Health-Related Quality of Life Assessment in Prostate Cancer Patient Undergoing Androgen Deprivation Therapy: Real-World Experience in the READT Study.

PURPOSE: To investigate the effect of androgen deprivation therapy (ADT) on health-related quality of life (HRQOL) in Asian men with all stages of prostate cancer. MATERIALS AND METHODS: READT (real-life evaluation of the effect of ADT in prostate cancer patients in Asia) was a multi-center, prospective observational study involving six sites across four Asian populations. We enrolled eligible prostate cancer patients, who opted for ADT alone or in combination without prior neoadjuvant or adjuvant ADT within 12 months. The EuroQoL-5 dimensions, 5 level scale (EQ-5D-5L) utility index scores and visual analog scale (VAS) were evaluated at baseline, month 6 and month 12. RESULTS: A total of 504 patients were recruited into READT between September 2016 and May 2020 with 52.9% diagnosed with metastatic prostate cancer. The EQ-5D-5L was evaluable in 442/504 (87.7%) of patients. Overall baseline EQ-5D-5L utility index score was 0.924 (interquartile range [IQR] 0.876-1.000). We observed a statistically significant difference in baseline EQ-5D-5L utility index score among different populations with a median EQ-5D-5L utility index score of 1 for Taiwan & Hong Kong, 0.897 for China and 0.838 for Malaysia. Similar trend was observed throughout multiple treatment time-points. Stage IV prostate cancer were significantly associated with a lower baseline EQ-5D-5L utility index score compared to stage I-III prostate cancer, producing a median disutility value of -0.080. Participants had a high median VAS (80, IQR 70-90), indicating good overall health on average during ADT initiation. CONCLUSIONS: The study highlights the differences in health state utility index scores among various Asian prostate cancer patients receiving ADT at real-world setting. Our findings will be informative and useful in cost-effectiveness evaluation and policy decision making.

Transurethral En Bloc Resection Versus Standard Resection of Bladder Tumour: A Randomised, Multicentre, Phase 3 Trial.

BACKGROUND: Conventionally, standard resection (SR) is performed by resecting the bladder tumour in a piecemeal manner. En bloc resection of the bladder tumour (ERBT) has been proposed as an alternative technique in treating non-muscle-invasive bladder cancer (NMIBC). OBJECTIVE: To investigate whether ERBT could improve the 1-yr recurrence rate of NMIBC, as compared with SR. DESIGN, SETTING, AND PARTICIPANTS: A multicentre, randomised, phase 3 trial was conducted in Hong Kong. Adults with bladder tumour(s) of ≤3 cm were enrolled from April 2017 to December 2020, and followed up until 1 yr after surgery. INTERVENTION: Patients were randomly assigned to receive either ERBT or SR in a 1:1 ratio. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was 1-yr recurrence rate. A modified intention-to-treat analysis on patients with histologically confirmed NMIBC was performed. The main secondary outcomes included detrusor muscle sampling rate, operative time, hospital stay, 30-d complications, any residual or upstaging of disease upon second-look transurethral resection, and 1-yr progression rate. RESULTS AND LIMITATIONS: A total of 350 patients underwent randomisation, and 276 patients were histologically confirmed to have NMIBC. At 1 yr, 31 patients in the ERBT group and 46 in the SR group developed recurrence; the Kaplan-Meier estimate of 1-yr recurrence rates were 29% (95% confidence interval, 18-37) in the ERBT group and 38% (95% confidence interval, 28-46) in the SR group (p = 0.007). Upon a subgroup analysis, patients with 1-3 cm tumour, single tumour, Ta disease, or intermediate-risk NMIBC had a significant benefit from ERBT. None of the patients in the ERBT group and three patients in the SR group developed progression to muscle-invasive bladder cancer; the Kaplan-Meier estimates of 1-yr progression rates were 0% in the ERBT group and 2.6% (95% confidence interval, 0-5.5) in the SR group (p = 0.065). The median operative time was 28 min (interquartile range, 20-45) in the ERBT group and 22 min (interquartile range, 15-30) in the SR group (p < 0.001). All other secondary outcomes were similar in the two groups. CONCLUSIONS: In patients with NMIBC of ≤3 cm, ERBT resulted in a significant reduction in the 1-yr recurrence rate when compared with SR (funded by GRF/ECS, RGC, reference no.: 24116518; ClinicalTrials.gov number, NCT02993211). PATIENT SUMMARY: Conventionally, non-muscle-invasive bladder cancer is treated by resecting the bladder tumour in a piecemeal manner. In this study, we found that en bloc resection, that is, removal of the bladder tumour in one piece, could reduce the 1-yr recurrence rate of non-muscle-invasive bladder cancer.

Transperineal Targeted Microwave Ablation (TMA) of localized prostate cancer guided by MRI-Ultrasound fusion and organ-based tracking: a pilot study.

BACKGROUND: To investigate the efficacy of transperineal targeted microwave ablation (TMA) in treating localized prostate cancer (PCa). METHODS: This is a single-centre prospective phase 2 trial recruiting men with low to intermediate-risk localized PCa to undergo transperineal TMA. TMA was performed with MRI-Ultrasound fusion guidance and organ-based tracking. A per-protocol 6-month MRI and biopsy were performed for all patients. The primary outcome was any cancer detected on biopsy of each ablated area. Secondary outcomes included per-patient analysis of positive biopsy, complications, urinary symptom score, erectile function and quality of life (QOL) scores. RESULTS: In the first 15 men, 23 areas were being treated. The median age was 70 years, number of TMA ablations were 5 (range 2-8), and the total ablation time and operating time was 22 (IQR 14-28) and 75 (IQR 65-85) minutes, respectively. PSA level dropped from a median of 7.7 to 2.4 ng/mL. For the primary outcome, 91.3% (21/23) ablated area had no cancer in 6-month biopsy. In per-patient analysis, 33.3% (5/15) had in or out-of-field positive biopsy at 6 months. Among these five cases, four of them were amenable to active surveillance and 1 (6.7%) case with out-of-field ISUP grade group 2 cancer received radiotherapy. The urinary symptoms, uroflowmetry, erectile function, and QOL scores had no significant difference at 6 months. One patient (out of five patients with normal erection) in the cohort complained of significant worsening of erectile function after TMA. Grade 1 complications including hematuria (33.3%), dysuria (6.7%), and perineal discomfort (13.4%) were observed. CONCLUSIONS: In this first pilot study, transperineal TMA guided by MRI-Ultrasound fusion guidance and organ-based tracking was shown to be effective, safe, and easily applicable in men with localized PCa.