Nutritional supplement with fermented soy in men with an elevated risk of prostate cancer and negative prostate biopsies: General and oncological results from the prospective PRAECAP trial.

INTRODUCTION & OBJECTIVES: To investigate the effect of a dietary supplement containing fermented soy on PSA, IPSS, changes in prostate volume and prostate cancer development after a 6-month challenge in men at increased risk of prostate cancer and negative previous biopsies. MATERIALS & METHODS: Patients with an elevated risk of PCa, defined by either 1 of the following criteria: PSA > 3 ng/ml, suspect lesion at digital rectal examination (DRE), suspect lesion at transrectal ultrasound (TRUS) / magnetic resonance imaging (MRI) and previous negative prostate biopsies (at least 8 cores) within 12 months before inclusion. Statistical analysis was carried out using a non-parametric one-sided paired Wilcoxon rank sum test, chi-square test and Fisher's exact test. RESULTS: In this trial, 94 patients where eligible for analysis. A PSA response was detected in 81% of the cases. In 25.8% (24/93) of patients, a decrease of at least 3 points on the IPSS was observed. The median prostate volume did not statistically change after 6 months (p=0.908). Patients with PSA modulation required fewer investigations and had fewer positive biopsies (p<0.001) and significantly fewer ISUP≥3 lesions (p=0.02). CONCLUSIONS: We observed a significantly lower PSA level after a 6-month challenge with a fermented soy-containing supplement, and an effect on IPSS in a subset of patients. Prescribing a fermented soy supplement in patients with an increased PCa risk could lead to a better selection of patients at real increased risk of having occult PCa.

Protein Biomarker Discovery Studies on Urinary sEV Fractions Separated with UF-SEC for the First Diagnosis and Detection of Recurrence in Bladder Cancer Patients.

Urinary extracellular vesicles (EVs) are an attractive source of bladder cancer biomarkers. Here, a protein biomarker discovery study was performed on the protein content of small urinary EVs (sEVs) to identify possible biomarkers for the primary diagnosis and recurrence of non-muscle-invasive bladder cancer (NMIBC). The sEVs were isolated by ultrafiltration (UF) in combination with size-exclusion chromatography (SEC). The first part of the study compared healthy individuals with NMIBC patients with a primary diagnosis. The second part compared tumor-free patients with patients with a recurrent NMIBC diagnosis. The separated sEVs were in the size range of 40 to 200 nm. Based on manually curated high quality mass spectrometry (MS) data, the statistical analysis revealed 69 proteins that were differentially expressed in these sEV fractions of patients with a first bladder cancer tumor vs. an age- and gender-matched healthy control group. When the discriminating power between healthy individuals and first diagnosis patients is taken into account, the biomarkers with the most potential are MASP2, C3, A2M, CHMP2A and NHE-RF1. Additionally, two proteins (HBB and HBA1) were differentially expressed between bladder cancer patients with a recurrent diagnosis vs. tumor-free samples of bladder cancer patients, but their biological relevance is very limited.

Mapping 3 procedure coding systems to the International Classification of Health Interventions (ICHI): coverage and challenges.

OBJECTIVE: To study the coverage and challenges in mapping 3 national and international procedure coding systems to the International Classification of Health Interventions (ICHI). MATERIALS AND METHODS: We identified 300 commonly used codes each from SNOMED CT, ICD-10-PCS, and CCI (Canadian Classification of Health Interventions) and mapped them to ICHI. We evaluated the level of match at the ICHI stem code and Foundation Component levels. We used postcoordination (modification of existing codes by adding other codes) to improve matching. Failure analysis was done for cases where full representation was not achieved. We noted and categorized potential problems that we encountered in ICHI, which could affect the accuracy and consistency of mapping. RESULTS: Overall, among the 900 codes from the 3 sources, 286 (31.8%) had full match with ICHI stem codes, 222 (24.7%) had full match with Foundation entities, and 231 (25.7%) had full match with postcoordination. 143 codes (15.9%) could only be partially represented even with postcoordination. A small number of SNOMED CT and ICD-10-PCS codes (18 codes, 2% of total), could not be mapped because the source codes were underspecified. We noted 4 categories of problems in ICHI-redundancy, missing elements, modeling issues, and naming issues. CONCLUSION: Using the full range of mapping options, at least three-quarters of the commonly used codes in each source system achieved a full match. For the purpose of international statistical reporting, full matching may not be an essential requirement. However, problems in ICHI that could result in suboptimal maps should be addressed.

Long-Term Outcomes and Genetic Predictors of Response to Metastasis-Directed Therapy Versus Observation in Oligometastatic Prostate Cancer: Analysis of STOMP and ORIOLE Trials.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.The initial STOMP and ORIOLE trial reports suggested that metastasis-directed therapy (MDT) in oligometastatic castration-sensitive prostate cancer (omCSPC) was associated with improved treatment outcomes. Here, we present long-term outcomes of MDT in omCSPC by pooling STOMP and ORIOLE and assess the ability of a high-risk mutational signature to risk stratify outcomes after MDT. The primary end point was progression-free survival (PFS) calculated using the Kaplan-Meier method. High-risk mutations were defined as pathogenic somatic mutations within ATM, BRCA1/2, Rb1, or TP53. The median follow-up for the whole group was 52.5 months. Median PFS was prolonged with MDT compared with observation (pooled hazard ratio [HR], 0.44; 95% CI, 0.29 to 0.66; P value < .001), with the largest benefit of MDT in patients with a high-risk mutation (HR high-risk, 0.05; HR no high-risk, 0.42; P value for interaction: .12). Within the MDT cohort, the PFS was 13.4 months in those without a high-risk mutation, compared with 7.5 months in those with a high-risk mutation (HR, 0.53; 95% CI, 0.25 to 1.11; P = .09). Long-term outcomes from the only two randomized trials in omCSPC suggest a sustained clinical benefit to MDT over observation. A high-risk mutational signature may help risk stratify treatment outcomes after MDT.

Multicentre, prospective study on local treatment of metastatic prostate cancer (LoMP study).

OBJECTIVES: To investigate the role of cytoreductive radical prostatectomy in addition to standard of care for patients with newly diagnosed metastatic prostate cancer. MATERIALS AND METHODS: This multicentre, prospective study included asymptomatic patients from 2014 to 2018 (NCT02138721). Cytoreductive radical prostatectomy was offered to all fit patients with resectable tumours, resulting in 40 patients. Standard of care was administered to 40 patients who were ineligible or unwilling to undergo surgery. The primary endpoint was castration resistant cancer-free survival at the time point of ≥50% events. The secondary endpoint was local event-free survival. Kaplan-Meier and Cox regression analyses with propensity-score analysis were applied. RESULTS: After a median (quartiles) follow-up of 35 (24-47) months, 42 patients became castration-resistant or died. The median castration resistant cancer-free survival was 53 (95% confidence interval [CI] 14-92) vs 21 (95% CI 15-27) months for cytoreductive radical prostatectomy compared to standard of care (P = 0.017). The 3-year estimates for local event-free survival were 83% (95% CI 71-95) vs 59% (95% CI 51-67) for cytoreductive radical prostatectomy compared to standard of care (P = 0.012). However, treatment group showed no significance in the multivariable models for castration resistant cancer-free survival (P = 0.5) or local event-free survival (P = 0.3), adjusted for propensity-score analysis. Complications were similar to the non-metastatic setting. Patients undergoing surgery were younger, with lower baseline prostate-specific antigen levels, alkaline phosphatase levels and metastatic burden. CONCLUSION: The present LoMP study was unable to show a difference between the two inclusion groups regarding castration resistant cancer-free survival for asymptomatic patients with newly diagnosed metastatic prostate cancer. These results validate previous evidence that, in well-selected and informed patients, cytoreductive radical prostatectomy is feasible and safe, with corresponding continence rates compared to the non-metastatic, high-risk setting. Whether cytoreductive radical prostatectomy could be a valuable option to achieve good local palliation needs to be further researched. Overall, the role of cytoreductive radical prostatectomy needs to be further explored in randomized studies to correct for potential bias.

Evaluation of the International Classification of Health Interventions (ICHI) in the coding of common surgical procedures.

OBJECTIVE: To evaluate the International Classification of Health Interventions (ICHI) in the clinical and statistical use cases. MATERIALS AND METHODS: We identified 300 most-performed surgical procedures as represented by their display names in an electronic health record. For comparison with existing coding systems, we coded the procedures in ICHI, SNOMED CT, International Classification of Diseases (ICD)-10-PCS, and CCI (Canadian Classification of Health Interventions), using postcoordination (modification of existing codes by adding other codes), when applicable. Failure analysis was done for cases where full representation was not achieved. The ICHI encoding was further evaluated for adequacy to support statistical reporting by the Organisation for Economic Co-operation and Development (OECD) and European Union (EU) categories of surgical procedures. RESULTS: After deduplication, 229 distinct procedures remained. Without postcoordination, ICHI achieved full representation in 52.8%. A further 19.2% could be fully represented with postcoordination. SNOMED CT was the best performing overall, with 94.3% full representation without postcoordination, and 99.6% with postcoordination. Failure analysis showed that "method" and "target" constituted most of the missing information for ICHI encoding. For all OECD/EU surgical categories, ICHI coding was adequate to support statistical reporting. One OECD/EU category ("Hip replacement, secondary") required postcoordination for correct assignment. CONCLUSION: In the clinical use case of capturing information in the electronic health record, ICHI was outperformed by the clinically oriented procedure coding systems (SNOMED CT and CCI), but was comparable to ICD-10-PCS. Postcoordination could be an effective and efficient means of improving coverage. ICHI is generally adequate for the collection of international statistics.

The Multicenter, Randomized, Phase 2 PEACE V-STORM Trial: Defining the Best Salvage Treatment for Oligorecurrent Nodal Prostate Cancer Metastases.

Optimal local treatment for nodal oligorecurrent prostate cancer is unknown. The randomized phase 2 PEACE V-STORM trial will explore the best treatment approach in this setting. Early results on the acute toxicity profile are projected to be published in quarter 3, 2021.

Small cell carcinoma of the prostate after low-dose-rate brachytherapy: a case report.

BACKGROUND: Small cell carcinoma of the prostate is a rare condition with important differences from prostatic adenocarcinoma in terms of clinical and prognostic characteristics. A low prostate-specific antigen and a symptomatic patient, including paraneoplastic symptoms, characterize small cell carcinoma of the prostate. Diagnosis is made on the basis of prostate biopsy, and fluorodeoxyglucose positron emission tomography/computed tomography is often used for staging because up to 60% of patients present with de novo metastatic disease. Patients with metastatic disease are usually treated with platinum-based cytotoxic chemotherapy regimens similar to those used for small cell carcinoma of the lung. However, prognosis remains poor, with a median overall survival of 9 to 17 months despite therapy. CASE PRESENTATION: This report describes a case of an 80-year-old Caucasian patient with lymph node and bone metastatic small cell carcinoma of the prostate following low-dose-rate brachytherapy for a low-risk prostate carcinoma and treated with chemotherapy and immunotherapy. CONCLUSION: Low-dose-rate brachytherapy might be an etiology of small cell prostate cancer.

A Trial-Based Cost-Utility Analysis of Metastasis-Directed Therapy for Oligorecurrent Prostate Cancer.

The optimal management of patients with oligorecurrent prostate cancer (PCa) is unknown. There is growing interest in metastasis-directed therapy (MDT) for this population. The objective was to assess cost-utility from a Belgian healthcare payer's perspective of MDT and delayed androgen deprivation therapy (ADT) in comparison with surveillance and delayed ADT, and with immediate ADT. A Markov decision-analytic trial-based model was developed, projecting the results over a 5-year time horizon with one-month cycles. Clinical data were derived from the STOMP trial and literature. Treatment costs were derived from official government documents. Probabilistic sensitivity analyses showed that MDT is cost-effective compared to surveillance (ICER: €8393/quality adjusted life year (QALY)) and immediate ADT (dominant strategy). The ICER is most sensitive to utilities in the different health states and the first month MDT cost. At a willingness-to-pay threshold of €40,000 per QALY, the cost of the first month MDT should not exceed €8136 to be cost-effective compared to surveillance. The Markov-model suggests that MDT for oligorecurrent PCa is potentially cost-effective in comparison with surveillance and delayed ADT, and in comparison with immediate ADT.

Laparoscopic bilateral groin hernia repair with one large self-fixating mesh: prospective observational study with patient-reported outcome of urological symptoms and EuraHS-QoL scores.

BACKGROUND: Laparoscopic bilateral inguinal hernia repair may be completed with one large self-fixating mesh crossing the midline. No studies have investigated in detail whether preperitoneal mesh placement induces temporary or more lasting urinary symptoms. METHODS: Urinary and hernia-related symptoms were evaluated preoperatively and postoperatively at 1, 3 and 12 months using the ICIQ-MLUTS questionnaire and EuraHS-QoL score in patients undergoing bilateral inguinal hernia repair. RESULTS: One hundred patients were included. Voiding symptoms and bother scores were unchanged at 1 or 3 months, but there was significant improvement at 12 months compared with preoperative findings (symptoms P < 0.001; bother score P < 0.01). Incontinence symptoms improved at 1 month (P < 0.05) but not at 3 or 12 months, with a bother score significantly improved at 1 month (P < 0.01) and 12 months (P < 0.01). Diurnal and nocturnal frequency did not change significantly postoperatively, but 12 months nocturnal bother score was decreased (P < 0.05). EuraHS-QoL scores showed statistical significant improvement in all three domains for all measurements at the different follow-up moments compared to previous measurements. Postoperative symptoms were improved at 12 months, compared with preoperative pain scores (- 6.1), restriction of activity (- 10.1) and cosmetic scores (- 4.7) These findings were statistically significant (P < 0.001). At 12 months, there were no patients with severe discomfort (score ≥ 5) for any of the three domains. No recurrences were diagnosed with 95% clinical follow-up at 12 months. CONCLUSION: Laparoscopic bilateral groin hernia repair with one large preperitoneal self-fixating mesh did not cause new urinary symptoms and demonstrated significant improvement in voiding symptoms at 12 months. Incontinence and nocturnal bother score were significantly improved. CLINICAL TRIAL REGISTRY IDENTIFIER: Clinical.Trials.gov: NCT02525666.

Development and external validation of a nomogram to predict lymph node invasion after robot assisted radical prostatectomy.

BACKGROUND: Prediction of lymph node invasion (LNI) after radical prostatectomy has been rarely assessed in robotically assisted laparoscopic radical prostatectomy (RALP) series. We aimed to develop and externally validate a pretreatment nomogram for the prediction of LNI following RALP in patients with high- and intermediate-risk prostate cancer. METHODS: 1654 RALP patients were prospectively collected between 2009 and 2016 from academic and community hospitals. We included patients with intermediate- and high-risk prostate cancer who underwent pelvic lymph node dissection (e-PLND). Logistic regression analysis was applied to construct a nomogram to predict LNI. Centers were randomly assigned to the training cohort (80%) and validation cohort (20%). The discriminative accuracies were evaluated by the areas under the curve and by the calibration plot. The net benefit of the nomogram to predict LNI was assessed by decision curve analysis and a cut-off was proposed. RESULTS: In total, 14% of the patients in our cohort had pN1 disease. Applying logistic regression analysis, the following covariates were chosen to develop the nomogram: initial PSA, clinical T stage, biopsy Gleason sum, and proportion of positive biopsy cores. The nomogram showed a median discriminative accuracy of 73% and excellent calibration. The net benefit of the model ranged between 7% and 51% predicted risk of LNI. A cut-off to perform e-PLND was set at 7%. This would permit a 29% of avoidable e-PLND, missing 9.4% of patients with LNI. CONCLUSIONS: We developed and externally validated a nomogram to predict LNI in patients treated with RALP from a prospective, multi-institutional, nationwide series. A risk of LNI > 7% is proposed as cut-off above which e-PLND is recommended.

Determination of variability due to biological and technical variation in urinary extracellular vesicles as a crucial step in biomarker discovery studies.

Urinary extracellular vesicles (EVs) are an attractive source of biomarkers for urological diseases. A crucial step in biomarker discovery studies is the determination of the variation parameters to perform a sample size calculation. In this way, a biomarker discovery study with sufficient statistical power can be performed to obtain biologically significant biomarkers. Here, a variation study was performed on both the protein and lipid content of urinary EVs of healthy individuals, aged between 52 and 69 years. Ultrafiltration (UF) in combination with size exclusion chromatography (SEC) was used to isolate the EVs from urine. Different experimental variation set-ups were used in this variation study. The calculated standard deviations (SDs) of the 90% least variable peptides and lipids did not exceed 2 and 1.2, respectively. These parameters can be used in a sample size calculation for a well-designed biomarker discovery study at the cargo of EVs.

Map-Assisted Generation of Procedure and Intervention Encoding (Magpie): An Innovative Approach for ICD-10-PCS Coding.

ICD-10-PCS coding is challenging because of the large number of codes, non-intuitive terms and paucity of the ICD-10-PCS index. We previously repurposed the richer ICD-9-CM procedure index for ICD-10-PCS coding. We have developed the MAGPIE tool based on the repurposed ICD-9-CM index with other lexical and mapping resources. MAGPIE helps the user to identify SNOMED CT and ICD-10-PCS codes for medical procedures. MAGPIE uses three innovative search approaches: cascading search (SNOMED CT to ICD-9-CM to ICD-10-PCS), hybrid lexical and map-assisted matching, and semantic filtering of ICD-10-PCS codes. Our evaluation showed that MAGPIE found the correct SNOMED CT code and ICD-10-PCS table in 70% and 85% of cases respectively, without any user intervention. MAGPIE is available online from the NLM website: magpie.nlm.nih.gov.

Current Management of pT3b Prostate Cancer After Robot-assisted Laparoscopic Prostatectomy.

BACKGROUND: Robot-assisted radical prostatectomy (RALP) in high-risk and locally advanced prostate cancer (PCa) is gaining increasing traction. The optimal use of additional treatments for PCa with seminal vesicle invasion (pT3b) after RALP remains ill explored. OBJECTIVE: To evaluate the management of pT3b PCa after RALP in current clinical practice. DESIGN, SETTING, AND PARTICIPANTS: As part of the prospective Belgian RALP Consortium project (October 2009-March 2016), 796 patients with pT3b disease were evaluated. INTERVENTION: Robot-assisted radical prostatectomy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Population and perioperative characteristics were described to assess surgical outcome. Multivariable regression analyses were used to identify independent predictors of lymph node invasion (pN1), positive surgical margins (R+), postoperative morbidity, and additional treatments. RESULTS AND LIMITATIONS: In this prospective population-based registry, 85% of patients with clinical high-risk locally advanced PCa received pelvic lymph node dissection (PLND). Early postoperative complications (0-30 d) were observed in 68 patients (8.5%). During oncologic follow-up (median 12 mo), 63% of pN1 patients and 56% of R+ patients received additional therapy. Performing PLND (necessary for assessing pN1 status) was a specific predictor for androgen deprivation therapy only, whereas R+ and younger age were independent predictors for radiotherapy only. Limitations include the nonstandardized policy on additional treatments among hospitals. CONCLUSIONS: In current practice, RALP is performed with acceptable morbidity for PCa with seminal vesicle invasion and the use of postoperative additional treatments is influenced by different patient, tumor, and surgical variables. Despite the recommendations, 15-21% of patients do not receive adequate pelvic lymph node staging and adjuvant therapy is given in 38% of patients. Full and correct staging of the real disease extent remains important in the management of these patients. PATIENT SUMMARY: This study on prostate cancer with seminal vesicle invasion after robot-assisted prostatectomy evaluates the use of additional treatments in current clinical practice. Additional treatments for advanced prostate cancer should be patient-adjusted according to the disease extent.

Bladder Cancer Diagnosis and Follow-Up: The Current Status and Possible Role of Extracellular Vesicles.

Diagnostic methods currently used for bladder cancer are cystoscopy and urine cytology. Cystoscopy is an invasive tool and has low sensitivity for carcinoma in situ. Urine cytology is non-invasive, is a low-cost method, and has a high specificity but low sensitivity for low-grade urothelial tumors. Despite the search for urinary biomarkers for the early and non-invasive detection of bladder cancer, no biomarkers are used at the present in daily clinical practice. Extracellular vesicles (EVs) have been recently studied as a promising source of biomarkers because of their role in intercellular communication and tumor progression. In this review, we give an overview of Food and Drug Administration (FDA)-approved urine tests to detect bladder cancer and why their use is not widespread in clinical practice. We also include non-FDA approved urinary biomarkers in this review. We describe the role of EVs in bladder cancer and their possible role as biomarkers for the diagnosis and follow-up of bladder cancer patients. We review recently discovered EV-derived biomarkers for the diagnosis of bladder cancer.

Development and External Validation of Nomograms To Predict Adverse Pathological Characteristics After Robotic Prostatectomy: Results of a Prospective, Multi-institutional, Nationwide series.

BACKGROUND: The possibility of predicting pathologic features before surgery can support clinicians in selecting the best treatment strategy for their patients. We sought to develop and externally validate pretreatment nomograms for the prediction of pathological features from a prospective multicentre series of robotic-assisted laparoscopic prostatectomy (RALP) procedures. DESIGN, SETTING, AND PARTICIPANTS: Between 2009 and 2016, data from 6823 patients undergoing RALP in 25 academic and community hospitals were prospectively collected by the Belgian Cancer Registry. Logistic regression models were applied to predict extraprostatic extension (EPE; pT3a,b-4), seminal vesicle invasion (SVI; pT3b), and high-grade locally advanced disease (HGLA; pT3b-4 and Gleason score [GS] 8-10) using the following preoperative covariates: prostate-specific antigen, clinical T stage, biopsy GS, and percentage of positive biopsy cores. Internal and external validation was performed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The stability of the model was assessed via tenfold cross-validation using 80% of the cohort. The nomograms were independently externally validated using the test cohort. The discriminative accuracy of the nomograms was quantified as the area under the receiver operating characteristic curve and graphically represented using calibration plots. RESULTS AND LIMITATION: The nomograms predicting EPE, SVI, HGLA showed discriminative accuracy of 77%, 82%, and 88%, respectively. Following external validation, the accuracy remained stable. The prediction models showed excellent calibration properties. CONCLUSIONS: We developed and externally validated multi-institutional nomograms to predict pathologic features after RALP. These nomograms can be implemented in the clinical setting or patient selection in clinical trials. PATIENT SUMMARY: We developed novel nomograms using nationwide data to predict postoperative pathologic features and lethal prostate cancer.

Re-purposing the ICD-9-CM Procedures Index for Coding in ICD-10-PCS and SNOMED CT.

Compared to the ICD-10-PCS index, the ICD-9-CM Procedure (ICD9V3) Index is richer and contains more clinician-friendly terms including abbreviations and eponyms. We re-purposed the ICD9V3 index by mapping the index terms to SNOMED CT and the ICD-9-CM codes to ICD-10-PCS codes through the General Equivalent Mappings. The re-purposed index outperformed the ICD-10-PCS index in the retrieval of ICD-10-PCS codes using a list of commonly used procedure names, with significantly higher recall, precision and F-score. We also derived a SNOMED CT to ICD-10-PCS map from the re-purposed ICD-9-CM index, which had a higher coverage of SNOMED CT concepts and comparable accuracy compared to a map derived from the ICD-10-PCS index. The re-purposed index will be a useful resource for ICD-10-PCS coders and for mapping between SNOMED CT and ICD-10-PCS.

Surveillance or Metastasis-Directed Therapy for Oligometastatic Prostate Cancer Recurrence: A Prospective, Randomized, Multicenter Phase II Trial.

Purpose Retrospective studies suggest that metastasis-directed therapy (MDT) for oligorecurrent prostate cancer (PCa) improves progression-free survival. We aimed to assess the benefit of MDT in a randomized phase II trial. Patients and Methods In this multicenter, randomized, phase II study, patients with asymptomatic PCa were eligible if they had had a biochemical recurrence after primary PCa treatment with curative intent, three or fewer extracranial metastatic lesions on choline positron emission tomography-computed tomography, and serum testosterone levels > 50 ng/mL. Patients were randomly assigned (1:1) to either surveillance or MDT of all detected lesions (surgery or stereotactic body radiotherapy). Surveillance was performed with prostate-specific antigen (PSA) follow-up every 3 months, with repeated imaging at PSA progression or clinical suspicion for progression. Random assignment was balanced dynamically on the basis of two factors: PSA doubling time (≤ 3 v > 3 months) and nodal versus non-nodal metastases. The primary end point was androgen deprivation therapy (ADT)-free survival. ADT was started at symptomatic progression, progression to more than three metastases, or local progression of known metastases. Results Between August 2012 and August 2015, 62 patients were enrolled. At a median follow-up time of 3 years (interquartile range, 2.3-3.75 years), the median ADT-free survival was 13 months (80% CI, 12 to 17 months) for the surveillance group and 21 months (80% CI, 14 to 29 months) for the MDT group (hazard ratio, 0.60 [80% CI, 0.40 to 0.90]; log-rank P = .11). Quality of life was similar between arms at baseline and remained comparable at 3-month and 1-year follow-up. Six patients developed grade 1 toxicity in the MDT arm. No grade 2 to 5 toxicity was observed. Conclusion ADT-free survival was longer with MDT than with surveillance alone for oligorecurrent PCa, suggesting that MDT should be explored further in phase III trials.

Current trends in patient enrollment for robotic-assisted laparoscopic prostatectomy in Belgium.

BACKGROUND: During the last decade, an inverse stage migration has been observed in radical prostatectomy series at tertiary centers. However, it remains unclear whether similar trends can also be observed in solely robotic practices, including nonreferral centers. The aim of this study was to investigate the clinical and pathological trends in robotic-assisted laparoscopic prostatectomy (RALP) enrollment in Belgium over a period of 6 years through an analysis of a prospective registry. METHODS: A prospective, multicenter database was constructed: consecutive patients undergoing RALP in Belgium from 2010 to 2015 were enrolled, and 7366 men were analyzed. Variations in clinical and pathological variables were explored as a function of the enrollment year with proportional odds for categorical variables and with linear regressions for continuous variables. RESULTS: Net increases were observed in the prostate-specific antigen levels, cT stage, and biopsy Gleason scores across the study years (P < .001). The rate of low-risk prostate cancer (PCa) decreased from 36% in 2010 to 21% in 2015, whereas the rate of intermediate-risk PCa rose from 47% to 58%, and the rate of high-risk PCa rose from 17% to 21%. In parallel, the pT2 stage rate decreased from 76% to 64%, and the rate of Gleason 6 (3 + 3) cases was reduced from 45% to 23% (P < .001). Conversely, the pT3a stage rate rose from 16% to 24%, the pT3b stage rate rose from 7% to 11%, and the rate of Gleason 7 (4 + 3) cases rose from 7% to 21% (P < .0001). Finally, more patients underwent node dissection, and positive lymph nodes were increasingly diagnosed (from 3% in 2010 to 7% in 2015). CONCLUSIONS: During the last 6 years of RALP implementation in Belgium, there was a significant increase in the enrollment of intermediate- and high-risk PCa patients. This yielded a significant increase in adverse pathological characteristics. These results suggest a paradigm shift in PCa treatment, with radical robotic surgery increasing for intermediate- and high-risk patients. Cancer 2017;123:4139-4146. © 2017 American Cancer Society.