Our objective was to evaluate the biodistribution, kinetics, and radiation dosimetry of CuCl in humans and to assess the ability of CuCl PET/CT to detect prostate cancer (PCa) recurrence in patients with biochemical relapse. We prospectively evaluated 50 PCa patients with biochemical relapse after surgery or external-beam radiation therapy. All patients underwentCuCl PET/CT, F-choline PET/CT, and multiparametric MRI within 15 d of each other. Experienced readers interpreted the images, and the detection rate (DR) of each imaging modality was calculated. Histopathology, when available; clinical or laboratory response; and multidisciplinary follow-up were used to confirm the site of disease. In parallel, biodistribution, kinetics of the lesions, and radiation dosimetry ofCuCl were evaluated. From a dosimetric point of view, an administered dose of 200 MBq forCuCl translated into a 5.7-mSv effective dose. Unlike F-choline,CuCl was not excreted or accumulated in the urinary tract, thus allowing thorough pelvic exploration. The maximum CuCl uptake at the sites of PCa relapse was observed 1 h after tracer injection. In our cohort, CuCl PET/CT proved positive in 41 of 50 patients, with an overall DR of 82%. The DRs of F-choline PET/CT and multiparametric MRI were 56% and 74%, respectively. The difference between the DRs ofCuCl PET/CT and F-choline PET/CT was statistically significant ( < 0.001). Interestingly, on considering prostate-specific antigen (PSA) value, CuCl PET/CT had a higher DR than F-choline PET/CT in patients with a PSA of less than 1 ng/mL. The biodistribution of CuCl is more suitable than that of F-choline for exploring the pelvis and prostatic bed. TheCuCl effective dose is like those of other established PET tracers. In patients with biochemical relapse and a low PSA level, CuCl PET/CT shows a significantly higher DR than F-choline PET/CT.
The equations represent a practical and effective instrument for preoperative clinical staging in patients with localized prostate cancer. By means of these mathematical formulas, one can assess the correct prognosis and--above all--plan the best therapeutic approach.
Background
The COVID-19 outbreak burdens non-COVID elective surgery patients with figures similar to the SARS-Cov-2, by creating an overwhelming demand, increasing waiting times and costs. New tools are urgently needed to manage elective access. The study assesses the SWALIS-2020 model ability to prioritize and optimize access to surgery during the pandemic.
Methods
A 2020 March - May feasibility-pilot study, tested a software-aided, inter-hospital, multidisciplinary pathway. All specialties patients in the Genoa Departments referred for urgent elective surgery were included in a multidisciplinary pathway adopting a modified Surgical Waiting List InfoSystem (SWALIS) cumulative prioritization method (PAT-2020) based on waiting time and clinical urgency, in three subcategories: A1-15 days (certain rapid disease progression), A2-21 days (probable progression), and A3-30 days (potential progression).
Results
Following the feasibility study (N=55 patients), 240 referrals were evaluated in 4 weeks without major criticalities (M/F=73/167, Age=68.7 +/- 14.0). Waiting lists were prioritized and monitored, and theatres allocated based on demand. The SWALIS-2020 score (% of waited-against-maximum time) at operation was 88.7 +/- 45.2 at week 1 and then persistently over 100% (efficiency), over a controlled variation (equity), with a difference between A3 (153.29 +/- 103.52) vs. A1 (97.24 +/- 107.93) (p <0.001), and A3 vs. A2 (88.05 +/- 77.51) (p <0.001). 222 patients underwent surgery, without related complications or delayed/failed discharges.
Conclusions
The pathway has selected the very few patients with the greatest need, optimizing access even with +30% capacity weekly modifications. We will use the pathway to manage active, backlog, and hidden waiting lists throughout the further pandemic phases, and are looking for collaboration for multi-center research. https://www.isrctn.com/ISRCTN11384058.
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