JAMA Oncol. Participants were high-risk, hormone-naive patients with newly diagnosed M0 prostate cancer starting long-term HT for the first time. Radiotherapy is encouraged in this group, but mandated for patients with node-negative N0 M0 disease only since November Planned RT use was recorded at entry. These nonrandomized data were consistent with previous trials that support routine use of RT with HT in patients with N0M0 disease.
Here we report devic successful detection of white visceral fat browning in a treated transgenic mouse model by longitudinal Z-Spectrum Imaging. Patients with low-risk disease, without intervention and minimum followup of 6 months were considered to have elected AS. Using our proposed MPUC risk stratification, patients were classified as lower—, high—, or highest—risk. The median wait time from OR booking to case completion was 55 days, however, the median wait time from the urology referral to procedure completion Shrimp health benefits was days. Karyotype was XY in 60, XX in 51 and mosaic in 14 patients. Kaplan—Meier method was used for recurrence—free survival RFS estimates. Joe kaplan prostate device total of patients were identified, with a Joe kaplan prostate device followup of However, previous works acquired distribution of lung lesions and ventilation defect region. These references were subsequently analyzed for patient population, statistical methods, tumor size, 5-year recurrence rates as lrostate as overall and cancer-specific survival rates OS, CSS.
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JAMA Oncol. Participants were high-risk, hormone-naive patients with newly diagnosed M0 prostate cancer starting long-term HT for the first time. Radiotherapy is encouraged in this group, but mandated for patients with node-negative N0 M0 disease only since November Planned RT use was recorded at entry.
These nonrandomized data were consistent with previous trials that support routine use of RT with HT in patients with N0M0 disease.
Research arms have recruited at overlapping times, but, throughout, the control arm has consistently been use of HT, with RT where appropriate. This article describes the prognosis for men with newly diagnosed, high-risk M0 disease, split by nodal involvement, to complement the outcomes that we have reported for patients with metastatic disease allocated to the control arm of the trial.
There is limited information on the natural history of patients with newly diagnosed, high-risk M0 prostate cancer receiving androgen deprivation therapy ADT either alone or with RT. Radiotherapy was to be given approximately 6 to 9 months after randomization, to allow adequate time for hormone response and avoid combination of RT and docetaxel for relevant patients. The intended use of RT is a stratification factor at trial entry.
We hypothesized that RT was associated with better prognosis in men with M0 disease, regardless of nodal involvement. We hypothesized that radiotherapy was associated with better prognosis in men with M0 prostate cancer, regardless of nodal involvement. Failure-free survival outcomes favored planned use of radiotherapy for patients with both N0M0 hazard ratio, 0. All patients were intended for first-line treatment with long-term HT for the first time, and this must have started no longer than 12 weeks prior to randomization.
Baseline investigations must have been completed prior to randomization, which included computed tomography or magnetic resonance imaging MRI of the pelvis and abdomen; bone scan or equivalent, for example, whole-body MRI; chest x-ray if chest was not included in the computed tomography or MRI; electrocardiogram; and PSA test.
There were no age restrictions; patients had to be fit for chemotherapy and have no significant cardiovascular history. For this cohort analysis, we selected men with newly diagnosed prostate cancer, which we defined as being diagnosed within 6 months prior to randomization, that was nonmetastatic, and who were randomized to the control arm of the STAMPEDE Trial between October and May Hormone therapy was to continue for at least 2 years or until disease progression. Treatment after these points was at the discretion of the consulting clinician.
Details of disease progression were obtained from progression forms. Details of reported RT were obtained from the RT detail form. All patients gave written, informed consent. Exact RT technique was at site discretion. Guidance was given within the trial protocol section 6.
Conformal or intensity-modulated radiotherapy IMRT should be used in all patients. Where patients have good clinical evidence that nodes are tumor free or where nodal radiotherapy is contraindicated eg, significant bowel disease , treatment may be given to the prostate gland and seminal vesicles only.
Conventionally an upper limit of 10 mm in short axis dimension is used to define normal size lymph node. Survival was defined as time from randomization to death from any cause. Failure-free survival was defined as time from randomization to the first of the following events: biochemical failure as defined herein ; progression either locally, in lymph nodes, or in distant metastases; or death from prostate cancer. Biochemical failure, based on the PSA nadir in the first 24 weeks after randomization, was defined as:.
Cause of death was determined by central review without reference to the allocated treatment. These analyses are nonrandomized and post hoc. Analyses were performed using Stata, version 13, using standard survival analysis methods. Kaplan-Meier estimates were used to produce survival curves. Median follow-up was determined through reverse censoring on death. The analyses of reported RT use employed a landmark approach, 13 , 14 in which analyses were timed from 6 months after randomization, to allow for RT to be started.
Radiotherapy schedules were grouped according to field and fractionation conventional or hypofractionated. Figure 1 shows the cohort selection process. Of eligible patients randomized to the trial from October 5, , to May 1, , were allocated to the control arm.
The data set was frozen in May , with median interquartile range [IQR] follow-up of 17 months in this cohort, and Figure 2 shows time from 6-month landmark to FFS by reported radical RT status, split by time-specified nodal status at baseline. There were patients with N0M0 disease randomized prior to November 15, Figure 1 shows the men planned for and receiving RT.
Failure-free survival was better among patients planned for radical RT against those not planned, with adjusted HR, 0. The exploratory landmark analysis selection in Figure 1 , timed from 6 months after randomization, compared patients who received RT against those not reporting RT regardless of planned use. A total of patients were failure free and uncensored at 6 months, so included in this analysis, receiving RT and 46 not reporting RT.
Failure-free survival was better with received RT: adjusted HR, 0. Figure 1 shows the patients planned for and receiving RT. Twenty-nine of 97 patients planned for RT did not report receiving it: 5 experienced disease progression within 6 months after randomization, and 24 had no RT data.
Failure-free survival was better among those planned for radical RT than those not planned: adjusted HR, 0. A total of patients were event free and uncensored at 6 months and included in the landmark analysis by reported RT regardless of planned use.
Failure-free survival was better among patients receiving RT: adjusted HR, 0. Reported RT is summarized for the subcohorts in Table 2. Table 2 also shows adverse effects associated with radical RT, using Radiation Therapy Oncology Group late toxic effect grading, for all patients receiving RT, split by nodal subcohorts.
Reported adverse effects were similar for patients with and without nodal involvement, with no grade 4 or 5 adverse effects reported. We selected a cohort of men with nonmetastatic, newly diagnosed, hormone-naive prostate cancer, at high risk of dying from the disease, who were treated with long-term ADT with or without RT. We found median FFS of 63 months for the full M0 cohort, from study entry.
Comparisons with other published series must be made with caution because of differences in case mix and the start time of estimate Table 3. Guidelines on RT doses and volumes were included in the protocol in an attempt to standardize practice. With publication of PR07 in , 18 the trial management group took the positive decision to mandate RT in this subgroup to ensure that the trial standard of care was updated to reflect the new evidence base.
Previous widespread concerns that RT was inappropriate in patients with high-risk nonmetastatic disease, due to high probability of occult metastases, thus appear to be misplaced, although RT could act by an abscopal effect.
However, the data presented here show a substantial effect of RT on FFS, consistent with that seen in the patients with N0M0 disease within the same data set, and also the published randomized data in patients with N0M0 disease.
Table 2 lists the RT fractionation to prostate and seminal vesicles and to lymph nodes. The data presented here are further consistent with the recent study published using retrospective, observational data from the US National Cancer Data Base, which reported data on men who received a diagnosis between and The main strengths of our cohort include the fact that patients were from multiple centers and that data were collected in a consistent, prospective fashion.
However, there are limitations. First, our substantive cohort was drawn from the control arm of a clinical trial, inevitably applying eligibility restrictions. Second, this is not a formally planned, randomized comparison and so numbers are small, and there are likely to be unmeasured confounders not accounted for in the analyses and potentially important differences in baseline characteristics because only men who were considered fit for RT were planned for RT and definitions of fitness for RT may have varied by site.
We therefore might expect men planned for RT to have better prognosis than men not planned for RT, and the treatment effect seen here to be an overestimate of the benefit, but the consistency of effect with those previously published randomized trials enforces confidence in there being a positive effect of RT. No such trial has reported or is planned to report, and construction of one would be at great financial cost while taking many years to provide reliable long-term data.
The control arm of a high recruiting trial, such as STAMPEDE, therefore makes efficient use of the wealth of data collected for the trial while incurring no extensive additional costs and simultaneously providing treatment safety and efficacy answers. We show here that a combination of both early ADT and RT, in suitable men, is effective in delaying time to first relapse, as well as being tolerable in terms of acute toxicity. Survival outcomes in this cohort of men with nonmetastatic, newly diagnosed disease were shown to be good, with time to progression increased by RT to the prostate with or without the pelvis, for patients both with and without nodal involvement.
Corresponding Author: Melissa R. Published Online: November 25, Author Contributions: Ms Spears and Mr Sydes had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Critical revision of the manuscript for important intellectual content: All authors. Conflict of Interest Disclosures: None reported. Additional Contributions: It was the decision of the trial management group to submit the manuscript for publication. Access to summary data and reports was available to all other co-authors. All individuals involved in the data analysis are identified as authors for the article. All Rights Reserved.
Figure 1. View Large Download. Table 1. FFS and survival for the full M0 control arm cohort eFigure 2. Clin Oncol R Coll Radiol. PubMed Google Scholar Crossref. Lancet Oncol. Google Scholar Crossref. Eur Urol.
BJU Int. Final report of the intergroup randomized study of combined androgen-deprivation therapy plus radiotherapy versus androgen-deprivation therapy alone in locally advanced prostate cancer. J Clin Oncol. Normal pelvic lymph nodes: evaluation with CT after bipedal lymphangiography. Speeding up the evaluation of new agents in cancer. J Natl Cancer Inst. Landmark analysis at the year landmark point. Circ Cardiovasc Qual Outcomes.
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The primary endpoint was MFS. Secondary endpoints included time to PSA progression, time to first use of new antineoplastic therapy, OS, and safety. Median duration of treatment was Nadir testosterone values following initiation of androgen—deprivation therapy ADT have been shown in several studies to be prognostic for outcome, including time to castration—resistant prostate cancer TTCRPC and cancer—specific survival CSS.
Using cryopreserved serum from the PR. Canadian patients in the PR. Descriptive statistics and correlation analyses were performed, with longitudinal changes categorized as stable, increasing, decreasing, or mixed. The prognostic value of individual steroid tertiles, as well as E 1 :E 2 , E 2 :T and DHT:T ratios were assessed by Kaplan—Meier analysis and Cox proportional hazards adjusted for baseline clinical variables.
A total of patients were included in the analysis who had a cryopreserved serum available within two years of randomization, with patients having two subsequent annual samples available for measurement. Limitations include the number of events for some groups. Serum sex steroids, including both androgens and estrogens, may act as prognostic biomarkers in men receiving ADT for recurrent prostate cancer.
Further investigation is warranted to support clinical use. The Genitourinary Research Consortium GURC identified a need to incorporate emerging trial evidence to develop a treatment algorithm to support physicians who treat advanced prostate cancer. A national working group of uro—oncologists, medical oncologists, and radiation oncologists examined clinical trial evidence and subsequently engaged in consensus discussions to develop a practice algorithm for the treatment and management of patients with metastatic castrate—resistant prostate cancer.
All patients should be offered clinical trials, if available. Lines of therapy include various sequences of androgen receptor AR —targeted agents, chemotherapy, and radium—, and consider patient risk status, medical comorbidities, and toxicity profiles of therapy. The emergence of new therapies in metastatic prostate cancer provide physicians with sequencing possibilities and opportunities for individualizing therapy.
The GURC practice algorithm is a tool to support the management of advanced metastatic prostate cancer. Further research may involve assessment of outcomes and economic analyses to determine the value of these algorithms in the community and academic settings. Since the algorithm was nationally developed and designed to reflect evidence—based and expert—consensus practice recommendations, it is possible some provinces will have funding policies that are incongruent with the algorithm.
In such cases, the variation of treatment access across provinces can be further examined. We conducted a retrospective 20—year cohort study in Saskatchewan male patients aged 40—89 years diagnosed with BPH between and There is a paucity of long—term data on the outcomes of salvage cryotherapy for locally recurrent prostate cancer following radiation therapy RT.
We aimed to investigate long—term outcomes by performing an analysis of case series from two centres. Patients undergoing salvage cryotherapy for biopsy—proven, localized radiorecurrent prostate cancer RRPCa from — were prospectively accrued. Preoperative characteristics, perioperative morbidity, and postoperative data were reviewed from a prospectively maintained database. A total of patients were identified, with a median followup of One hundred ninety—nine Salvage cryotherapy is, therefore, a viable treatment option for localized RRPCa.
Prospective trials are required for validation. A significant proportion of men will not benefit from salvage radiotherapy SRT after radical prostatectomy RP. Imaging was double—read with consensus.
There was documentation of the treatment plan before and after imaging to assess management impact. Median PSA at imaging was 0. The findings had a significant impact on patient management and treatment outcomes.
Oxybutynin has long been the only drug approved for the treatment of overactive bladder OAB in children. Some children have a suboptimal response or suffer from side effects, dictating the necessity for other drugs to gain approbation. Our objectives were to assess and compare the efficacy and safety of fesoterodine and oxybutynin XL in the treatment of children with OAB.
We performed a randomized, double—blind trial with a crossover design in 64 children with OAB aged 5—14 years. Every child received a daily dose of one of the two study drugs feso 4 mg or oxy XL 10 mg for an eight—week period. After a washout of three days, they did a second eight—week period with the other agent.
Followup visits were scheduled Weeks 0, 2, 10, A three—day voiding diary was filled out before each visit. The efficacy and safety of the drugs were assessed through changes on the voiding diaries, the Patient Perception of Bladder Condition PPBC score, side effects, vital signs, urinalysis, post—void residual, electrocardiography ECG , and blood tests.
At the end of the study, children were asked to choose witch drug they preferred. At each visit, the safety and efficacy were evaluated, as previously described. Patients were either in Group 1 or 2 feso—oxy or oxy—feso.
Both groups were similar. All had improvement of the parameters evaluated at four months. We could not demonstrate a significant difference between the two drugs. The differences between the PPBC score of the two drugs was of 0. All noted side effects were mild and there were no major adverse events. Fesoterodine or oxybutynin XL appeared to be effective and safe treatment options for OAB in children. According to our current data, the efficacy and safety of both molecules seems similar.
Boys with hypospadias often undergo reconstructive surgery to improve cosmetic appearance and functional outcomes. There is a paucity of research regarding the parental disclosure of past urological procedures, specifically hypospadias repair. Our objective was to determine the rate of parental disclosure in boys undergoing hypospadias repair and to evaluate the parental perspectives regarding concerns and amount of support in relation.
Data was analyzed using descriptive statistics and Chi—squares. One hundred and forty—two survey responses were collected. The majority of respondents were North American There was a significant difference in nervousness to disclose if the condition was distal vs. To our knowledge, this is the first study to evaluate perceptions and attitudes around disclosure in patients with hypospadias and their families.
The majority of respondents were planning to disclose the operation to their child and were not offered any guidance or support as to the optimal way to disclose. Half of those parents thought they could benefit from resources to help them with this process. Further research is required to understand the impact of disclosure and to create tools to help caregivers with this responsibility. The role of breastfeeding BF in preventing urinary tract infections UTIs in infants with prenatal hydronephrosis PHN has, to our knowledge, not been investigated.
From —, we prospectively screened patients with HN. The primary outcome was UTI rate. Univariate and multivariate analyses of predetermined UTI risk factors were done. BF had no effect on the rate of fUTI in this population, regardless of the intensity or duration.
Although there has been indication in the literature that BF may provide some protection for infants against developing infections, in our cohort of infants with HN, no protective effect was seen for fUTI. CAP and etiology of the HN were the driving factors.
Urinary bacteria may contribute to the development of calcium stone disease. Previous epidemiological studies have demonstrated a correlation between culture proven urinary tract infections and stone disease.
Flies were pulverized and cultured on lysogeny broth agar plates on Days 1—5 to determine if UTI89 persisted in the flies. Stone burden was assessed with a fecal crystal assay and survival curve analysis.
Dosing with UTI89 did not affect the survival of healthy flies fed normal food. There was a trend towards decreased survival in flies exposed to the combination of UTI89 and oxalate food. These findings suggest that the presence of a non—urease producing E.
The incidence and risk factors for stone development in this population remain unknown. After obtaining ethics approval, we retrospectively reviewed the data of patients who underwent HD between and at two tertiary care centres. We included patients who have been initiated on HD for at least three months and had computed tomography scans or ultrasound imaging both prior to and post—initiation of HD.
Patients with stones antedating HD were excluded. De novo stones were defined as either symptomatic or asymptomatic calculi found on imaging. Epidemiological data, serum analyses, and comorbidities were collected and compared between stone—formers and non—stone—formers using univariate, multivariate logistic regression analysis, and adjusted odds ratio OR.
A total of patients were included in the analysis, The mean age was After HD, 18 The stone—former group had significantly lower serum magnesium levels 0. Binary logistic regression analysis demonstrated that serum uric acid levels adjusted OR 1.
Less de novo stones were noted in hypertensive patients, in whom hypertension may represent a surrogate for absent urine production. Moses technology has been shown to improve the fragmentation efficiency and reduced stone retropulsion both in in vivo and in vitro studies. However, there are no randomized trials evaluating effectiveness of this new technology during laser lithotripsy.
Therefore, the objective was to compare regular and Moses modes of holmium laser lithotripsy in terms of stone fragmentation efficiency and perioperative complications. After obtaining ethics approval, a prospective, double—blind, randomized trial was conducted for patients undergoing holmium laser lithotripsy. Patients were randomly assigned to have holmium laser lithotripsy with either regular or Moses modes. Both patients and surgeons were blinded to the laser mode.
All procedures were performed by four experienced urologists. Demographic data, stone parameters, perioperative complications, and success rates were compared.