Ignace Billiet

Comparative analysis of prostate-specific antigen free survival outcomes for patients with low, intermediate and high risk prostate cancer treatment by radical therapy. Results from the Prostate Cancer Results Study Group

Whats known on the subject? and What does the study add?

FDG-PET/CT for the preoperative lymph node staging of invasive bladder cancer.

BACKGROUND Locoregional lymph node metastasis is an important prognostic factor in patients with bladder cancer. Multimodal treatment, depending on preoperative stage, may improve survival. The standard imaging modalities for staging (computed tomography [CT] or magnetic resonance imaging [MRI]) have an accuracy range of 70-90% for lymph node staging. A more accurate preoperative diagnostic test could improve survival rates even more. OBJECTIVE To determine whether the use of 2-deoxy-2 [F] fluoro-D-glucose (FDG) positron emission tomography (PET) in combination with CT (FDG-PET/CT) can increase the reliability of preoperative lymph node staging in patients with nonmetastatic invasive bladder cancer (T2 or higher, M0) or recurrent high-risk superficial disease (T1G3 with or without Tis, M0). DESIGN, SETTING, AND PARTICIPANTS Fifty-one patients underwent a preoperative FDG-PET/CT between April 2004 and December 2007. Independent of the result for lymph node status, all patients underwent a radical cystectomy and an extended lymphadenectomy. The FDG-PET/CT and CT results were compared with the definitive pathologic results. MEASUREMENTS Among the 51 patients, 13 patients had metastatically involved locoregional lymph nodes, diagnosed on histopathology. In six patients, these nodes demonstrated increased FDG uptake on PET. In seven patients, PET/CT did not diagnose the positive lymph nodes. PET/CT was false positive in one patient. RESULTS AND LIMITATIONS For the diagnosis of node-positive disease, the accuracy, the sensitivity, and the specificity of FDG-PET/CT were 84%, 46%, and 97%, respectively. When analysing the results of CT alone, there was accuracy of 80%, sensitivity of 46%, and specificity of 92%. The use of FDG-PET/CT is hampered by technical limitations. CONCLUSIONS We found no advantage for combined FDG-PET/CT over CT alone for lymph node staging of invasive bladder cancer or recurrent high-risk superficial disease.

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.

Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium

BackgroundIn Belgium, bladder cancer is the fifth most common cancer in males (5.2%) and the sixth most frequent cause of death from cancer in males (3.8%). Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. This suggests that selenium may also be suitable for chemoprevention of recurrence.MethodThe SELEBLAT study opened in September 2009 and is still recruiting all patients with non-invasive transitional cell carcinoma of the bladder on TURB operation in 15 Belgian hospitals. Recruitment progress can be monitored live at http://www.seleblat.org Patients are randomly assigned to selenium yeast (200 μg/day) supplementation for 3 years or matching placebo, in addition to standard care. The objective is to determine the effect of selenium on the recurrence of bladder cancer. Randomization is stratified by treatment centre. A computerized algorithm randomly assigns the patients to a treatment arm. All study personnel and participants are blinded to treatment assignment for the duration of the study.DesignThe SELEnium and BLAdder cancer Trial (SELEBLAT) is a phase III randomized, placebo-controlled, academic, double-blind superior trial.DiscussionThis is the first report on a selenium randomized trial in bladder cancer patients.Trial registrationClinicalTrials.gov identifier: NCT00729287

Prevalence and prognosis of low-volume, oligorecurrent, hormone-sensitive prostate cancer amenable to lesion ablative therapy

To describe the anatomical patterns of prostate cancer (PCa) recurrence after primary therapy and to investigate if patients with low‐volume disease have a better prognosis as compared with their counterparts.

Cytoreductive Prostatectomy for Metastatic Prostate Cancer: First Lessons Learned From the Multicentric Prospective Local Treatment of Metastatic Prostate Cancer (LoMP) Trial

OBJECTIVE To prospectively evaluate patients with newly diagnosed metastatic prostate cancer in the context of the LoMP trial (which investigates the role of cytoreductive radical prostatectomy [cRP] in addition to standard of care [SoC]) and to provide a preliminary analysis of patients characteristics, safety of cRP, and early local symptoms. PATIENTS AND METHODS cRP was performed in asymptomatic patients with a resectable tumor and who were fit to undergo surgery (group A, n = 17). Only SoC was administered to patients with metastatic prostate cancer ineligible or unwilling to undergo cRP (group B, n = 29). At 3 months, surgical complications related to cRP and local symptoms for both groups were evaluated. RESULTS Median operation time, blood loss, and hospital stay for cRP were 215 minutes (150-290), 250 mL (100-900), and 4 days (2-7), respectively. Respectively 5 (29.4%) and 2 (11.8%) patients suffered grades 1 and 2 complications within 3 months postoperatively. When compared with Group B, patients in group A were younger (64 vs 72 years, P = .005), had lower initial prostate-specific antigen (15.9 vs 156 µg/L, P = .002), and less high-volume metastatic disease (5.9% vs 69%, P <.001). At 3 months, 5 (29.4%) patients in group A reported stress urinary incontinence without any further local symptoms. In group B, respectively 2 (6.8%), 11 (37.9%), and 2 (6.8%) patients suffered urge incontinence, obstructive voiding needing medical intervention, and ureteric obstruction. CONCLUSION In a group of well-selected patients, cRP is safe. These patients have more favorable characteristics compared with patients treated with only SoC. If only SoC can be offered, patients are at risk to suffer from local symptoms.

Introducing new technology safely into urological practice

PurposeSurgical innovation is necessary to ensure continued improvement in patient care. However, several challenges unique to the surgical craft are encountered during the development and validation of such new technology. This article highlights some of these challenges and gives an overview of existing solutions.MethodsA Pubmed review was performed about the “introduction of new technology” to identify challenges. Cross-referencing was used to explore the possible solutions per challenge.ResultsSeveral characteristics of the surgical craft itself limit our ability to establish randomised controlled trials and hence provide clear categorical evidence. Existing certification bodies for new technology often use unstructured regulations and allow fast-track bypassing systems. Consequently the IDEAL framework (innovation, development, exploration, assessment, long-term follow-up) proposes an objective scientific approach whilst defining stakeholder responsibilities. The selection of which new modality to implement is heavily influenced by third parties unrelated to the best patient outcomes and thus professional organisations can aid in this decision-making. Appropriate training of surgeons and their teams until proficiency is achieved is essential prior to credentialling. Finally long-term surveillance of outcomes in the form of registries is an increasing responsibility of the urological community to maintain our role in directing the adoption or rejection of these innovations.ConclusionUrological innovation is a dynamic and challenging process. Increasing efforts are identified within the urological community to render the process more reliable and transparent.

APPLES AND ORANGES: COMPARISON OF TREATMENT METHODS FOR PROSTATE CANCER USING BIOCHEMICAL RECURRENCE AS AN ENDPOINT

Sir, Aragona et al . [ 1 ] report the trend towards successful conservative management of high-grade renal injury witnessed elsewhere [ 2 ] . Over the 5-year period from 2006 to 2010, only one patient with American Association for the Surgery of Trauma (AAST) grade III or IV blunt renal trauma required open surgery in their level I trauma centre. Nevertheless, emergency nephrectomy remains a life-saving treatment for unstable grade V renal injuries. From 2004 to 2008, there were only 62 nephrectomies performed for renal trauma in England [ 3 ] . This is a slight reduction compared with the previous 5-year period (1999 – 2003), when there were 71 cases. This small and reducing number of cases ultimately means that most urologists are lacking regular exposure to such emergency procedures. Additionally, the laparoscopic approach for elective nephrectomy is now the established procedure for most benign and malignant cases, and intradepartmental subspecialisation has resulted in many urologists being on-call who do not regularly perform open nephrectomies. Furthermore, a recent study has highlighted a signifi cant decline in the number of open radical nephrectomies performed by UK urological trainees [ 4 ] .

Phase III randomised chemoprevention study of Selenium on the recurrence of non-invasive bladder cancer. The SELEnium and BLAdder cancer Trial (SELEBLAT)

Background In Belgium, bladder cancer is the fifth most common cancer in males (5.2%) and the sixth most frequent cause of death from cancer in males (3.8 %). The per-patient lifetime cost is the highest of all other types of cancer. Previous epidemiological studies have consistently reported that selenium concentrations were inversely associated with the risk of bladder cancer. We therefore hypothesized that selenium may also be suitable for chemoprevention of recurrence.