Comparison of prostate cancer detection rates of various prostate biopsy methods for patients with prostate-specific antigen levels of <10.0 ng/mL in real-world practice

Purpose: Several strategies of prostate biopsy (PBx) have been introduced to improve prostate cancer (PCa) detection rates. However, studies comparing cancer detection rates (CDRs) according to biopsy methods in real-world practice are scarce. This study aimed to investigate CDRs according to the biopsy methods for patients with prostate-specific antigen (PSA) <10.0 ng/mL. Materials and Methods: From 2006 to 2015, patients who underwent PBx were initially selected. All patients were categorized according to the biopsy methods performed (magnetic resonance imaging targeted biopsy [MR-TBx], 12+2 hypoechoic lesion target biopsy, saturation biopsy [sPBx], extended biopsy, and 12-core PBx). The CDR of MR-TBx was compared to that of sPBx and other protocols. Volume per core (VPC) was defined as prostate volume divided by the number of biopsy cores. Patients previously diagnosed with PCa were excluded. Results: Of the 1,598 patients (median PSA, 5.41 ng/mL), 401 (25.1%) were diagnosed with PCa. Among the biopsy methods, MR-TBx has the highest CDR and proportion of Gleason score ≥7 (3+4). Biopsy methods, VPC, age, prostate volume, and PSA were associated with PCa detection. In the sub-analysis for initial biopsy, MR-TBx had no significant difference with sPBx, but had higher CDR than the other biopsy protocols. For repeat biopsy, VPC, rather than the biopsy method, was associated with CDR. Conclusions: This study reaffirmed the efficacy of MR-TBx on CDR in real-world practice. In cases with barriers to performing magnetic resonance imaging, VPC might be useful for adjusting the optimal number of biopsy cores in repeat biopsy.ope

The Association of A Number of Predictive Factors for The Recurrence of Papillary Urothelial Neoplasm of Low Malignant Potential: Prognostic Analysis From Multiple Academic Centers.

PURPOSE: To identify clinically useful predictors for the recurrence of papillary urothelial neoplasm of low malignant potential (PUNLMP), we reviewed the clinical information of patients who were diagnosed and treated in multiple tertiary-care academic facilities. MATERIALS AND METHODS: Between February 2007 and April 2015, 95 patients diagnosed with PUNLMP after transurethral resection of bladder (TURB) were included in this study. Age, gender, body mass index, smoking history, the presence or absence of previous history of urothelial neoplasm, the presence or absence of gross hematuria, cytological results at the time of diagnosis, tumor diameter, and multiplicity of tumor were estimated as variablesfor analysis. Cox regression tests were used for identifying predictive factors for recurrence of PUNLMP. RESULTS: Sixty-nine cases of PUNLMP were de novo primary bladder PUNLMPs without known urothelial lesions in the urinary tract, and 26 PUNLMPs were identified on surveillance biopsies of patients with a previous history of urothelial neoplasm. During the follow-up period, recurrences developed in 13 patients (13.7%). Recurrence rates were 4.2% and 9.5% at 12 and 24 months, respectively. On univariate and multivariate Cox regression analyses, previous history of urothelial neoplasm [95% confidence interval (CI): 0.057-0.604, hazard ratio (HR) = 0.185, P = .005] and multiplicity of tumors [95% CI = 0.064-0.584, HR = 0.193, P = .004] were identified as independent predictors for recurrence-free survival of patients with PUNLMP. CONCLUSION: Tumor multiplicity and previous history of urothelial neoplasm are independent prognostic factors forprediction of recurrence of PUNLMP. More careful and closer follow-up should be recommended for PULNMPpatients with tumor multiplicity or a previous history of urothelial neoplasm.ope

Apalutamide for patients with metastatic castrationsensitive prostate cancer in East Asia: a subgroup analysis of the TITAN trial

Ethnicity might be associated with treatment outcomes in advanced prostate cancer. This study aimed to evaluate the efficacy and safety of androgen deprivation therapy (ADT) combined with apalutamide in East Asians with metastatic castration-sensitive prostate cancer (mCSPC). The original phase 3 Targeted Investigational Treatment Analysis of Novel Anti-androgen (TITAN) trial was conducted at 260 sites in 23 countries. This subgroup analysis included patients enrolled in 62 participating centers in China, Japan, and Korea. Radiographic progression-free survival (PFS), time to prostate-specific antigen (PSA) progression, and PSA changes from baseline were compared between groups in the East Asian population. The intent-to-treat East Asian population included 111 and 110 participants in the apalutamide and placebo groups, respectively. The 24-month radiographic PFS rates were 76.1% and 52.3% in the apalutamide and placebo groups, respectively (apalutamide vs placebo: hazard ratio [HR] = 0.506; 95% confidence interval [CI], 0.302-0.849; P = 0.009). Median time to PSA progression was more favorable with apalutamide than placebo (HR = 0.210; 95% CI, 0.124-0.357; P < 0.001). Median maximum percentages of PSA decline from baseline were 99.0% and 73.9% in the apalutamide and placebo groups, respectively. The most common adverse event (AE) was rash in the apalutamide group, with a higher rate than that in the placebo group (37.3% vs 9.1%). The most common grade 3 or 4 AEs were rash (12 [10.9%]) and hypertension (12 [10.9%]) for apalutamide. The efficacy and safety of apalutamide in the East Asian subgroup of the TITAN trial are consistent with the global results.ope

Is targeted biopsy really needed when performing systematic prostate biopsy to raise the detection rate for prostate cancer in patients with prostate-specific antigen ≤10 ng/mL?

Targeted biopsy with multiparametric magnetic resonance imaging and hypoechoic lesions on transrectal ultrasound has been implemented to increase prostate cancer detection rate.We compared the detection abilities of systematic prostate biopsy, hypoechoic lesion-targeted biopsy (HL-TBx), and cognitive magnetic resonance imaging-targeted biopsy (MRI-TBx) in patients with suspected prostate cancer. Between September 2014 and August 2016, 193 patients with a prostate-specific antigen level of 3 to 10 ng/mL underwent HL-TBx or MRI-TBx. In patients who refused magnetic resonance imaging examination before prostate biopsy, HL-TBx was performed. We compared cancer detection rates and pathologic outcomes between systematic prostate biopsy and HL-TBx or MRI-TBx.The cancer detection rates for HL-TBx and MRI-TBx were 40.8% and 43.8%, respectively, without a significant difference (P = .683). Of the 81 patients diagnosed with prostate cancer, most patients (77 patients, 95.1%) were diagnosed with prostate cancer by systematic prostate biopsy. The detection ability for prostate cancer was significantly better for systematic prostate biopsy than for HL-TBx or MRI-TBx (P < .001).The detection abilities for clinically significant prostate cancer similar between HL-TBx and systematic prostate biopsy. Systematic prostate biopsy alone should be recommended for detection prostate cancer in patients with a prostate-specific antigen ≤10 ng/mL.ope

Translation Validity and Reliability of the Korean Version of the DAN-PSS

Purpose: The Danish Prostate Symptom Score (DAN-PSS) is known to be a good tool for evaluating the voiding symptoms and sexual life stati in the treatment of BPH. Recently, linguistic translations into Korean have been performed with validity and reliability tests. The DAN-PSS is composed of 24 questionnaires on voiding symptom and 6 on sexual function stati. Materials and Methods: An urologist and special translators participated in the translation of the DAN-PSS into Korean. The validity and reliability of the questions on the sexual stati of the Korean DAN-PSS were tested. A total of sixty-nine men, aged from 41 to 69, who visited out institute for voiding problems, and diagnosed with BPH, were included for the questionnaires. They all replied to the Korean DAN-PSS questionnaires within 48 hours after completing the DAN-PSS questionnaires. A further forty-seven men replied twice to the Korean DAN-PSS, at 2 weeks interval. Both the validity and the reliability of the Korean DAN-PSS were evaluated. Results: There was no statistically significant difference between the DAN-PSS and its Korean version (p>0.05). Similarly, there was no statistically significant difference in the 2 sets of answers for the Korean version of the DAN-PSS at 2 week interval (p>0.05). Conclusions: The translation of the DAN-PSS into Korean was valid and reliable. The Korean DAN-PSS is as a good a tool as the DAN-PSS in the evaluatione of sexual life stati.ope

United in Fight against prOstate cancer (UFO) registry: first results from a large, multi-centre, prospective, longitudinal cohort study of advanced prostate cancer in Asia

Objectives To document the management of advanced prostate cancer including diagnosis, prognosis, treatment, and care, in real-world practice in Asia using the United in Fight against prOstate cancer (UFO) registry. Patients and Methods We established a multi-national, longitudinal, observational registry of patients with prostate cancer presenting to participating tertiary care hospitals in eight Asian countries. A total of 3636 eligible patients with existing or newly diagnosed high-risk localised prostate cancer (HRL), non-metastatic biochemically recurrent prostate cancer (M0), or metastatic prostate cancer (M1), were consecutively enrolled and are being followed-up for 5 years. Patient history, demographic and disease characteristics, treatment and treatment decisions, were collected at first prostate cancer diagnosis and at enrolment. Patient-reported quality of life was prospectively assessed using the European Quality of Life-five Dimensions, five Levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy for Prostate Cancer questionnaires. In the present study, we report the first interim analysis of 2063 patients enrolled from study start (15 September 2015) until 18 May 2017. Results Of the 2063 enrolled patients, 357 (17%), 378 (19%), and 1328 (64%) had HRL, M0 or M1 prostate cancer, respectively. The mean age at first diagnosis was similar in each group, 56% of all patients had extracapsular extension of their tumour, 28% had regional lymph node metastasis, and 53% had distant metastases. At enrolment, 62% of patients had at least one co-morbidity (mainly cardiovascular disease or diabetes), 91.8% of M1 patients had an Eastern Cooperative Oncology Group performance score of <2 and the mean EQ-5D-5L visual analogue score was 74.6-79.6 across cohorts. Treatment of M1 patients was primarily with combined androgen blockade (58%) or androgen-deprivation therapy (either orchidectomy or luteinising hormone-releasing hormone analogues) (32%). Decisions to start therapy were mainly driven by treatment guidelines and disease progression. Decision to discontinue therapy was most often due to disease progression (hormonal drug therapy) or completion of therapy (chemotherapy). Conclusion In the UFO registry of advanced prostate cancer in Asia, regional differences exist in prostate cancer treatment patterns that will be explored more deeply during the follow-up period; prospective follow-up is ongoing. The UFO registry will provide valuable descriptive data on current disease characteristics and treatment landscape amongst patients with prostate cancer in Asia.ope

Clinical studies investigating the use of leuprorelin for prostate cancer in Asia

Background: Leuprorelin is a well-established treatment for prostate cancer (PCa); however, there is limited information on its use in Asian males. This review of English language publications between January 2000 and 2016 describes the outcomes of clinical trials on leuprorelin in Asian males with PCa of any grade, stage, or histopathology. Methods: The literature search was undertaken using PubMed, Cochrane Library, and ClinicalTrials.gov databases. Results: We identified nine studies from Japan, two studies from South Korea, and one international, multisite study which included Asian sites, with a total of 1,652 males previously diagnosed with PCa. All studies included subcutaneous or depot administration of leuprorelin at varying dose levels including 3.75 mg four weekly, 11.25 mg 12 weekly, or 22.5 mg every 12 or 24 weeks. Leuprorelin was administered as monotherapy or in combination with chemotherapy or hormonal therapy. Leuprorelin appears well tolerated in Asian males and is effective in reducing serum testosterone to castration levels (<50 ng/dL (<1.7 nmol/L)) and prostate-specific antigen levels. Common adverse events included hot flushes and mild hepatic dysfunction. Leuprorelin was shown to provide reasonable survival rates in PCa (T1b-T3N0M0) and in metastatic disease; another reasonable option for these patients is radiation therapy. Leuprorelin treatment also improved the quality of life. Conclusion: Leuprorelin may be an appropriate and efficacious treatment for males with PCa (T1b-T3N0M0). Leuprorelin treatment was well tolerated and associated with improvement in the quality of life.ope

Impact of Cerebrovascular Disease on Survival Benefits from Local Treatment in Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer

PURPOSE: Local treatment has become a treatment option for patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC). Subgroup analyses based on a history of cerebrovascular disease (CVD) were performed to evaluate the impact thereof on overall survival (OS) after local treatment. MATERIALS AND METHODS: A retrospective analysis was performed for 879 patients with de novo mHSPC between August 2003 and November 2016. Patients were stratified according to prior CVD history and the type of initial treatment: androgen-deprivation therapy (ADT) alone versus local treatment consisting of radical prostatectomy (RP) or radiation therapy (RT) with ADT, with or without metastasis-directed therapy. The primary outcome was OS assessed by Kaplan-Meier analysis and Cox-regression models. RESULTS: Of 879 patients, 660 (75.1%) men underwent ADT alone, and 219 (24.9%) men underwent RP or RT with ADT, with or without metastasis-directed therapy. The median follow-up was 38 months. Multivariable analysis showed CVD history to be associated with a higher risk of overall mortality (p=0.001). In the overall cohort and in patients without a history of CVD, patients who underwent local treatment exhibited higher OS than men who received ADT alone (all p<0.001). However, the survival benefit conferred by local treatment was not seen in patients with a history of CVD (p=0.324). OS was comparable between patients who received RP and RT (p=0.521). CONCLUSION: Local treatment with or without metastasis-directed therapy may provide OS advantages for mHSPC patients without a history of CVD. Further prospective studies are needed to address these important concerns.ope

Efficacy and safety of degarelix in Korean patients with prostate cancer requiring androgen deprivation therapy: Open-label multicenter phase III study

PURPOSE: To assess the noninferiority, efficacy, and safety of degarelix in achieving and maintaining testosterone at castrate levels (≤0.5 ng/mL) in Korean patients (CS42) versus non-Asian patients with prostate cancer (PCa). METHODS: A Phase III, open-label, multicenter, single-arm trial was conducted in Korean patients with PCa. Degarelix was administered at a starting dose of 240 mg followed by monthly (28-day intervals) maintenance doses of 80 mg (240/80 mg dose regimen) for 7 months. The results were compared with non-Asian patients receiving degarelix 240/80 mg in the CS21 study. RESULTS: The estimated difference in the cumulative probabilities of testosterone ≤0.5 ng/mL from Day 28 to Day 196 between the trials was -2.3% (96.7% in CS42 vs. 99.0% in CS21). The lower limit of the 95% confidence interval was -5.5%, i.e., above the predefined noninferiority limit of -10% and thus noninferiority was established. Decreases in serum testosterone, prostate-specific antigen, and luteinizing hormone over time were similar in CS42 and CS21. There were no clinically significant differences in incidence of treatment-emergent adverse events (72% in CS42 vs. 70% in CS21) and changes in clinical chemistry and hematology parameters between the two trials. The most common adverse event was injection-site reaction. CONCLUSIONS: Overall, degarelix was effective and well tolerated in Korean patients. Testosterone suppression was noninferior to that in non-Asian patients and safety findings were as would be expected for elderly men with PCa undergoing androgen deprivation therapy.ope

Meta-analysis of Alpha Receptor Antagosist for Benign Prostatic Hyperplasia from Papers that were Published in Korea

Purpose: Many reliable articles on the effectiveness of alpha blockers have been published. Evidence-based diagnostic guidelines and therapeutic guidelines for benign prostatic hypertrophy(BPH), which is one of the most common urological diseases, have been proposed in many foreign countries. This paper examines the efficacy of alpha blocker, a common therapeutic drug for BPH, in Korean patients through meta-analysis. Materials and Methods: From 1993 to 2001, the term 'BPH' and alpha blocker for BPH were used as key words to search for related articles in the Medical Research Information Center, the National Assembly Library of the Republic of Korea, the Korean Journal of Andrology and the Korean Journal of Urology. A total of 10 articles were selected as being suitable for evaluation and these articles were ranked with levels ranging from I to V, where level I indicated a large randomized controlled trial and level V indicated a non-controlled case accumulation study. Results: There were improvements for the symptom score(45.3%), and for the maximum urinary flow rate(36.0%). The reasons for patient drop-outs were follow-up loss for 60%, drug side effects for 11%, and ineffectiveness of drug for 6.8%. The common side effects were dizziness (4.2%), orthostatic hypotension(2.2%), and headache(1.7%). The blood pressure was sustained in the normotensive patients, wheareas BP showed a tendency to be reduced in hypertensive patients. Conclusions: Treatment with alpha blocker resulted in the BPH patients in all the studies receiving sustained benefit. Yet most of these papers were short-term, non randomized case-accumulation studies. However, BPH is a chronic disease that may worsen over time. Therefore, evaluation of long term tolerability and efficacy of alpha blocker is necessary.ope