Metastasis-directed therapy in castration-refractory prostate cancer (MEDCARE): a non-randomized phase 2 trial.

BACKGROUND: Patients diagnosed with metastatic castration-refractory prostate cancer (mCRPC) rely on a limited number of therapeutic agents resulting in a median survival of 2-3 years. A subgroup of those patients with mCRPC presents with oligoprogressive disease, with a limited number of progressive lesions while other metastases are still controlled by ongoing systemic treatment. METHODS: In this single arm prospective phase II trial, we aim to include 18 patients with oligoprogressive mCRPC (1-3 metastases and/or local recurrence) who will be treated with metastasis-directed therapy to all visible progressive lesions. Progression is based on conventional imaging, as the use of PSMA PET-CT is considered investigational. However all patients will undergo PSMA PET-CT and the images will be blinded until progression. Primary endpoint is the postponement of the start of next-line systemic treatment (NEST) and the additional clinical value of PSMA PET-CT. Recruitment of patients for this trial started in January 2020 and will be completed approximately by December 2020. DISCUSSION: In this phase 2 trial on oligoprogressive mCRPC, we will investigate the benefit of progression-directed therapy while continuing ongoing systemic treatment. We hypothesize that progression-directed therapy (PDT) with surgery or stereotactic body radiation therapy for these oligoprogressive lesions will postpone the start of next-line systemic treatment and therefore serve as a new or add-on therapy in the spectrum of treatments available for mCRPC. The results of this trial will serve as guidance for a later randomized phase 3 trial. All participants are given an information sheet and are required to give written informed consent. Results will be published in a peer-reviewed journal. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov: NCT04222634 (December 18th 2019).

Survey on surgery for stress urinary incontinence in an era mid-urethral slings are being questioned.

INTRODUCTION: Concerns about vaginal mesh have reduced the use of mid-urethral slings (MUS) in some countries. In view of their potential withdrawal in Belgium and The Netherlands, we polled urogynaecologists on their practice for treating stress urinary incontinence (SUI) and what their experience is with alternative procedures, and we asked them how their patients perceive the risk and success rates. METHODS: A survey among members of the pelvic floor special interest group of the Flemish Society for Obstetrics and Gynaecology, Belgian Association of Urology and Dutch Society of Obstetrics and Gynaecology. RESULTS: Their primary procedure of choice is the MUS (99%). Sixty-five per cent performs at least 25 MUS yearly; they report high success (90%; IQR [85-92]) and low adverse outcome rates. Physicians anticipate complications as reported in the literature: 5% (IQR [410]) overactive bladder, 5% (IQR [2-10]) voiding problems, 2% (IQR [15]) exposures, 2% (IQR [1-5]) dyspareunia and 1% (IQR [1-3]) chronic pain. Eighty-five per cent of physicians report their patients express fears about having a MUS though usually they cannot precisely tell why. Reportedly they tell their physicians of concerns about pain (54%), exposure (45%), dyspareunia (25%), voiding problems (15%) or overactive bladder (8%). Only half of respondents had ever performed a colposuspension. The majority of these were older and performed colposuspension via laparotomy. Only six (4%) had performed > 20 colposuspensions yearly. CONCLUSION: Dutch and Belgian urogynaecologists estimate success and adverse effect rates of MUS in line with the literature. Their patients most cited worries were fear of chronic pain and exposure. Only half of respondents had ever performed a colposuspension. They were older and performed the procedure via laparotomy.

The more you look, the more you find: challenging results on FDG-PET CT in a patient with neurofibromatosis type I.

BACKGROUND: FDG-PET/CT is part of the standard diagnostic management of a patients with a large variety of common and less common malignant tumors, based on the increased glucose metabolism within tumors. CASE PRESENTATION: A hybrid fluorodeoxyglucose positron emission tomography and computed tomography (FDG-PET/CT) was performed in a neurofibromatosis patient to rule out relapse of malignant peripheral nerve sheet tumor. The scan revealed non-malignant neurofibromas, a testis seminoma and hypermetabolic syphilitic granulomata. CONCLUSION: This case stresses the need to rule out infectious diseases when atypical hypermetabolic lesions are present.

OPCAB versus early mortality and morbidity: an issue between clinical relevance and statistical significance.

OBJECTIVE: To evaluate the impact of OPCAB on major postoperative events in a large consecutive cohort of patients, covering the complete spectrum of risk. METHODS: A consecutive series of 3333 CABG patients operated in a single institution (Jan/97-Jan/03) is analyzed after a complete (98%) midterm reengineering towards off-pump surgery (Oct/99). Patients in cardiogenic shock are excluded. The on- (N=1593) or off-pump (N=1740) datasets are comparable for most demographic and non-cardiac variability. The studied events are early mortality, early stroke, early infarct, early dialysis and hospital stay. Three methods adjust for possible patient selection: similar datasets, forced inclusion of a saturated OPCAB propensity score and finally multivariate correction. RESULTS: Non-risk adjusted. The 3-month survival was 96.7+/-0.4% (OPCAB) and 95.9+/-0.5% (ECC) (P=0.2). The 8-day freedom from stroke was 99.4+/-0.2% (OPCAB) and 98.5+/-0.3% (ECC) (P=0.004). The prevalence of dialysis was 1.67% in OPCAB and 2.27% in ECC (P=0.2). The 8-day freedom from infarct was 98.4+/-0.2% (OPCAB) and 98.3+/-0.2% (ECC) (P=0.7). The freedom from hospital discharge day 15 was 17.6+/-0.9% (OPCAB) and 18.4+/-0.8% (ECC) (P=0.001). Propensity score corrected and adjusted for event-related variability. The survival effect remained non-significant (P=0.3), also for patients with a EuroSCORE>8 (P=0.9). The stroke effect became non-significant (P=0.2), but stayed significant for patients with severe internal carotid artery stenosis (P=0.02). The dialysis-effect remained non-significant (P=0.6), also for patients with an elevated creatinine (P=0.7). The early infarct-effect remained non-significant (P=0.8), also for the female patients (P=0.8). The hospital discharge was significantly influenced by the OPCAB approach for the total group (P=0.02) as well as for the patients with EuroSCORE>8 (P=0.01). CONCLUSIONS: The observed 20% reduction of mortality, 60% reduction of stroke and 20% reduction of dialysis were partly neutralized by the adjusting methods and demand, at least, larger datasets to obtain statistical significance. Subdatasets with fewer patients but higher risk identified risk-reducing effects for stroke. Hospital stay was shortened by the OPCAB approach. The interactions between risk, number of patients and the risk-reducing effect are the cornerstones of evidence generation for the OPCAB approach. These results were obtained through a very strict reengineering and cannot be extended to all OPCAB programs.