End-fire versus side-fire: a randomized controlled study of transrectal ultrasound guided biopsies for prostate cancer detection.

Objectives: To compare prostate cancer detection rates between end-fire and side-fire ultrasound guided prostate biopsy techniques.Methods: A prospective randomized controlled trial was performed in patients who underwent prostate biopsy between 2009 and 2014. Patients were randomly assigned to the end-fire or side fire biopsy groups and underwent transrectal ultrasound guided prostate biopsy. The overall prostate cancer detection rate was compared between the two probe configurations. Trial was registered at Clinical Trials.gov with identifier: NCT00851292.Results: A total of 730 patients were included and randomized, 371 patients underwent prostate biopsy with side-fire probe and 359 patients with the end-fire probe. Prostate cancer detection rates were 52.4% in the end fire group and 45.6% in the side fire group (p = .066).Conclusions: No significant difference was found in detection rate of prostate cancer between the end-fire and side-fire probe in transrectal ultrasound guided prostate biopsy, neither for detection rate of prostate cancer in the apex.

A Urine Based Genomic Assay to Triage Patients with Hematuria for Cystoscopy.

PURPOSE: Current clinical guidelines recommend cystoscopy in patients who present with hematuria to rule out a bladder tumor. We evaluated whether our previously developed urine assay was able to triage patients with hematuria for cystoscopy in a large prospective cohort. MATERIALS AND METHODS: A urine sample was collected before cystoscopy and mutation/methylation status of 6 genes was determined on cellular DNA. The existing diagnostic model was validated on this cohort. Logistic regression was applied to investigate other potential variables. The primary end point was the model performance as indicated by the AUC. Secondary end points were sensitivity, specificity and negative predictive value. Clinical usefulness was determined by the net benefit approach. RESULTS: In 838 patients biomarker status could be determined for all genes. Urothelial cancer was observed in 112 patients (98 of 457 in the gross and 14 of 381 in the microscopic hematuria group). Validation of the existing model resulted in an AUC of 0.93. Logistic regression analysis identified type of hematuria as a significant additional variable. Adding type of hematuria resulted in an AUC of 0.95 (96% sensitivity, 73% specificity, 99% negative predictive value). The assay identified all upper tract tumors not visible by cystoscopy (in 6). Net benefit analysis showed that the urine assay should be preferred over current clinical practice. Implementing the urine assay as a triage tool could lead to a 53% reduction in cystoscopies. CONCLUSIONS: The urine assay detected urothelial cancer with a very high accuracy and can be used to triage patients presenting with hematuria for cystoscopy.

Long-term follow-up after active surveillance or curative treatment: quality-of-life outcomes of men with low-risk prostate cancer.

PURPOSE: To compare long-term (4-10 years) quality of life (QoL) of men with low-risk prostate cancer (PCa) treated by different modalities and a reference group without PCa. METHODS: In this cross-sectional study, four groups were sent a one-time QoL-questionnaire; PCa patients (1) following the structured Prostate cancer Research International Active Surveillance protocol, (2) who underwent radical prostatectomy (RP) in the context of the European Randomized study of Screening for Prostate Cancer-section Rotterdam, (3) who underwent radiotherapy (RT) at an academic hospital in The Netherlands, and (4) an age-matched reference group of men without PCa. The QoL-questionnaire addressed prostate-specific health (EPIC), generic health (SF-12), and anxiety (STAI-6). Statistical significance (p ≤ 0.05) and clinical relevance (≥0.5 SD) of differences between groups were assessed. RESULTS: The AS, RP, RT, and reference group response rates amounted to 74% (122/165), 66% (70/106), 66% (221/335), and 75% (205/273), respectively. At a mean of 6.6 years of follow-up, active surveillance (AS)-men reported better urinary function [M = 93.0 (SD = 10.6) vs. 80.0 (SD = 19.1), p ≤ 0.001], less urinary incontinence [M = 90.0 (SD = 14.6) vs. 70.1 (SD = 28.8), p ≤ 0.001], and better sexual function [M = 40.9 (SD = 24.6) vs. 14.8 (17.7), p ≤ 0.001, clinically relevant] than RP-men. Compared to RT, AS-men reported better sexual function [M = 40.9 (SD = 24.6) vs. 25.8 (SD = 25.0), p = 0.069]. The four groups reported similarly low anxiety levels; the number of highly anxious men (STAI ≥ 44) ranged from 8 to 13%. For all QoL domains, men on AS and men without PCa reported very similar scores. CONCLUSIONS: Prostate-specific function of AS-men was significantly better than that of RP-men. When comparing AS to RT, a borderline significant difference in sexual function was seen. Men who followed an AS strategy for a long-term period were not anxious and accepted it well, suggesting that AS may be a good treatment option for men with low-risk PCa.

Cancer survivors' preference for follow-up care providers: a cross-sectional study from the population-based PROFILES-registry.

BACKGROUND: The best practice for the organization of follow-up care in oncology is under debate, due to growing numbers of cancer survivors. Understanding survivors' preferences for follow-up care is elementary for designing patient-centred care. Based on data from prostate cancer and melanoma survivors, this study aims to identify: 1) preferences for follow-up care providers, for instance the medical specialist, the oncology nurse or the general practitioner; 2) characteristics associated with these preferences and 3) the preferred care provider to discuss cancer-related problems. MATERIAL AND METHODS: Survivors diagnosed with prostate cancer (N = 535) and melanoma (N = 232) between 2007 and 2013 as registered in The Netherlands Cancer Registry returned a questionnaire (response rate was 71% and 69%, respectively). A latent class cluster model analysis was used to define preferences and a multinomial logistic regression analysis was used to identify survivor-related characteristics associated with these preferences. RESULTS: Of all survivors, 29% reported no preference, 40% reported a preference for the medical specialist, 20% reported a preference for both the medical specialist and the general practitioner and 11% reported a preference for both the medical specialist and the oncology nurse. Survivors who were older, lower/intermediate educated and women were more likely to have a preference for the medical specialist. Lower educated survivors were less likely to have a preference for both the medical specialist and the general practitioner. Overall, survivors prefer to discuss diet, physical fitness and fatigue with the general practitioner, and hereditary and recurrence with the medical specialist. Only a small minority favored to discuss cancer-related problems with the oncology nurse. CONCLUSION: Survivors reported different preferences for follow-up care providers based on age, education level, gender and satisfaction with the general practitioner, showing a need for tailored follow-up care in oncology. The results indicate an urgency to educate patients about transitions in follow-up care.

Short-term outcomes of the prospective multicentre 'Prostate Cancer Research International: Active Surveillance' study.

OBJECTIVE: To evaluate the short-term outcomes of the prospective international Prostate Cancer Research International: Active Surveillance ('PRIAS') study (Dutch Trial Register NTR1718), as active surveillance (AS) for early prostate cancer might provide a partial solution to the current overtreatment dilemma in this disease. PATIENTS AND METHODS: The first 500 (of >950) participants with asymptomatic T1c/T2 prostate cancer, with a prostate-specific antigen (PSA) level of < or =10.0 ng/mL, a PSA density of <0.2 ng/mL/mL, a Gleason score of < or =3 + 3 = 6, and one or two positive biopsy cores, were analysed. The follow-up protocol consisted of frequent PSA measurements, digital rectal examinations, and standard repeat biopsies (the first after 1 year). The primary outcome is survival free of active therapy; the secondary endpoints are reasons for stopping AS, findings in 1-year repeat biopsies, and outcomes after radical prostatectomy (RP). RESULTS: Patients were included between December 2006 and July 2008. The median (25-75th percentile) follow-up after diagnosis was 1.02 (0.6-1.5) years. The 2-year survival rate free from active therapy was 73%. Of the 82 men who changed to active therapy during the follow-up, 68 (83%) did so based on the protocol. Of the 261 repeat biopsies available for analysis, 90 (34%) showed no cancer, while 57 (22%) showed a Gleason score of >6 or more than two positive biopsy cores. There was a relatively unfavourable PSA doubling time of 0-10 years in 53% (102/194) and 62% (33/53) of men with favourable and unfavourable re-biopsy results, respectively. After RP, four of 24 (17%) men had T3 disease and 12 (50%) had a Gleason score of >6. CONCLUSION: AS seems feasible, but mortality outcomes are unknown. A strict follow-up protocol including standard 1-year repeat biopsies resulted in a quarter of men stopping AS after 2 years.