Patient and Context Factors in the Adoption of Active Surveillance for Low-Risk Prostate Cancer.

Importance: Although active surveillance for patients with low-risk prostate cancer (LRPC) has been recommended for years, its adoption at the population level is often limited. Objective: To make active surveillance available for patients with LRPC using a research framework and to compare patient characteristics and clinical outcomes between those who receive active surveillance vs radical treatments at diagnosis. Design, Setting, and Participants: This population-based, prospective cohort study was designed by a large multidisciplinary group of specialists and patients' representatives. The study was conducted within all 18 urology centers and 7 radiation oncology centers in the Piemonte and Valle d'Aosta Regional Oncology Network in Northwest Italy (approximate population, 4.5 million). Participants included patients with a new diagnosis of LRPC from June 2015 to December 2021. Data were analyzed from January to May 2023. Exposure: At diagnosis, all patients were informed of the available treatment options by the urologist and received an information leaflet describing the benefits and risks of active surveillance compared with active treatments, either radical prostatectomy (RP) or radiation treatment (RT). Patients choosing active surveillance were actively monitored with regular prostate-specific antigen testing, clinical examinations, and a rebiopsy at 12 months. Main Outcomes and Measures: Outcomes of interest were proportion of patients choosing active surveillance or radical treatments, overall survival, and, for patients in active surveillance, treatment-free survival. Comparisons were analyzed with multivariable logistic or Cox models, considering centers as clusters. Results: A total of 852 male patients (median [IQR] age, 70 [64-74] years) were included, and 706 patients (82.9%) chose active surveillance, with an increasing trend over time; 109 patients (12.8%) chose RP, and 37 patients (4.3%) chose RT. Median (IQR) follow-up was 57 (41-76) months. Worse prostate cancer prognostic factors were negatively associated with choosing active surveillance (eg, stage T2a vs T1c: odds ratio [OR], 0.51; 95% CI, 0.28-0.93), while patients who were older (eg, age ≥75 vs <65 years: OR, 4.27; 95% CI, 1.98-9.22), had higher comorbidity (Charlson Comorbidity Index ≥2 vs 0: OR, 1.98; 95% CI, 1.02-3.85), underwent an independent revision of the first prostate biopsy (OR, 2.35; 95% CI, 1.26-4.38) or underwent a multidisciplinary assessment (OR, 2.65; 95% CI, 1.38-5.11) were more likely to choose active surveillance vs active treatment. After adjustment, center at which a patient was treated continued to be an important factor in the choice of treatment (intraclass correlation coefficient, 18.6%). No differences were detected in overall survival between active treatment and active surveillance. Treatment-free survival in the active surveillance cohort was 59.0% (95% CI, 54.8%-62.9%) at 24 months, 54.5% (95% CI, 50.2%-58.6%) at 36 months, and 47.0% (95% CI, 42.2%-51.7%) at 48 months. Conclusions and Relevance: In this population-based cohort study of patients with LRPC, a research framework at system level as well as favorable prognostic factors, a multidisciplinary approach, and an independent review of the first prostate biopsy at patient-level were positively associated with high uptake of active surveillance, a practice largely underused before this study.

Randomized prospective trial comparing immediate versus delayed ureteroscopy for patients with ureteral calculi and normal renal function who present to the emergency department.

PURPOSE: To compare the safety and efficacy of emergency vs scheduled ureteroscopy with a prospective study that included patients who presented to the emergency department (ED) with renal colic from ureteral stones. PATIENTS AND METHODS: There were 271 consecutive patients who were enrolled in this prospective study. Patients were randomized to emergency ureteroscopy (group A) or delayed ureteroscopy (group B). All patients underwent helical unenhanced CT (HUCT). Stone-free status was defined as the complete absence of residual fragments at 1 week postoperatively, assessed with HUCT, with no need for ancillary interventions after ureteroscopy. RESULTS: Group A included 139 assessable patients. The overall stone-free rate was 93%. Neither location nor size was a significant prognostic factor (P>0.05). Single-session ureteroscopy failed to clear nine ureteral stones. A Double-J stent was placed in 27/139 patients. Group B included 100 assessable patients. Patients in the control group were scheduled for ureteroscopy after their departure from the ED. The overall stone-free rate was 90%. Single-session ureteroscopy failed to clear 10 ureteral stones. A Double-J stent was placed in 80/100 patients. There were no statistical differences with regard to stone diameter and location, complications, and stone-free rate between group A and group B patients. The rate of Double-J stent positioning was significantly higher (P<0.05) in group B patients. CONCLUSIONS: In our experience, emergency ureteroscopy showed equal efficacy and safety compared with the elective procedure. It has the main advantage of providing both immediate relief from pain and stone fragmentation.

Feasibility of 21-day continuous infusion of epirubicin in hormone-refractory prostate cancer patients.

BACKGROUND: Epirubicin (EPX) has been found to be active in hormone-refractory prostate cancer (HRPC) patients. Prolonged EPX infusion has never been investigated in this patient subset. PATIENTS AND METHODS: A feasibility study was conducted in which EPX was administered in 21-day continuous infusion to 15 patients with HRPC. The EPX dose was 5 mg/m2 daily for 21 consecutive days (one course). One week was allowed before starting the next course. RESULTS: The patients received 1 to 6 courses (median 3). As a whole, the treatment was well tolerated. Nine patients did not develop any toxicity, while WHO grade 3 and 4 toxicities were recorded in 4 patients. Alopecia (WHO grade 1-2) was presented in 4 cases. Five patients attained >50% decrease in serum prostate-specific antigen (PSA). CONCLUSION: Prolonged EPX infusion is feasible and potentially active in the treatment of HRPC patients. Our data suggest caution in administering this treatment in patients bearing rheumatologic disease.

Seminal monolateral nerve-sparing radical prostatectomy in selected patients.

INTRODUCTION: In recent years there has been a shift in prostate cancer stage with the majority of patients nowadays being operated with cT1c disease, prostate-specific antigen levels of <10 ng/ml, and a decreased rate of seminal vesicle invasion. Recent data suggest the role of preservation of the seminal vesicle in improving continence and/or potency. We describe our preliminary experience with seminal-sparing, unilateral nerve-sparing retropubic radical prostatectomy. PATIENTS AND METHODS: 21 selected patients with clinically localized prostate cancer underwent seminal unilateral nerve-sparing retropubic radical prostatectomy (seminal-sparing group, SSG). We compared the postoperative continence, erectile function and quality of orgasm results to those obtained in a control group (CG) of 21 patients who underwent unilateral nerve-sparing radical prostatectomy. Sexual function was evaluated preoperatively and 9 months postoperatively with the 5-item International Index of Erectile Function (IIEF-5) questionnaire and with other self-administered questionnaires. The quality of orgasm was evaluated 9 months postoperatively. RESULTS: 1 month postoperatively, 95 and 28% of the patients in the SSG and CG were continent (p<0.001). The median postoperative drop in IIEF-5 score was 5 points in SSG and 14.5 points in CG (p<0.0001). Nine months postoperatively, 90 and 62% of the patients in SSG and CG, respectively (p=0.05), maintained the ability to achieve orgasm. CONCLUSIONS: In our experience seminal-sparing radical prostatectomy showed good feasibility and improved early postoperative urinary continence, erectile function and quality of orgasm, without compromised cancer control.

PSA decrease after levofloxacin therapy in patients with histological prostatitis.

OBJECTIVE: To evaluate the effect of levofloxacin (LVX) oral therapy on total serum prostate specific antigen (PSA) values in patients with histological prostatitis. MATERIALS AND METHODS: All consecutive outpatients with histological evidence of chronic prostatitis, total PSA > 4 ng/ml, normal DRE and urinalysis and treated once daily with LVX 500 mg per os for 20 days were retrospectively evaluated for total serum PSA reduction. A decrease of PSA value > 5% was considered correlated with the antibiotic therapy. RESULTS: A total of 26 outpatients were evaluated (median age = 65 years). Median total serum PSA concentrations, before and after LVX therapy, were 7.1 ng/ml (range 4.1-15 ng/ml) and 5.8 ng/ml (2-15 ng/ml), respectively (p= n.s). The median reduction of total PSA was 16.6% (range 5.7 - 63.6%). A statistically significant decrease of median total PSA was observed in 15 out of 26 patients (57.6%): 7.2 ng/ml and 4.2 ng/ml before and after LVX therapy, respectively (p=0.002); the marker normalized in 7 out of 15 patients (46.7%). In all the remaining patients prostate biopsy was repeated: prostate cancer (Pca) was detected in 1 out of 8 patients with significant reduction of total PSA and in 4 out of 11 patients with no significant marker decrease. The incidence of Pca in second prostate biopsies raised from 19% (5 cases out of 26) to 26% (5 cases out of 19). CONCLUSIONS: Treatment with LVX significantly reduced PSA values in over half of the patients with asymptomatic prostatitis, elevated total PSA and normal DRE and urinalysis. This approach could be applied in the ambulatory setting in order to increase the specificity of total PSA testing, reducing the number of negative, unnecessary, prostate biopsies.

[Clinical surveillance after surgery for prostate cancer]. / Sorveglianza clinica dopo terapia chirurgica del carcinoma prostatico.

The incidence of prostate cancer is remarkably increased in the last decade. This dramatic epidemiological change can be primarily attributed to the widespread use of prostate specific antigen (PSA) as a diagnostic tool. Nowadays most of the prostate cancers are detected at an early stage and the age of the patients is decreased. This has led to a significantly increase in the number of prostate cancer patients treated by radical prostatectomy. Serum determination of PSA is the standard method to monitor the disease after radical surgery, while other tests can be required only when PSA is detectable. After radical prostatectomy the mean half-life of PSA is 1.5 days and it must become undetectable to consider a patient free of disease. A value greater than 0.4 ng/ml, with an increase in two determination, indicates a recurrence of the disease. PSA is an extremely sensitive marker. In fact, in patients who underwent radical prostatectomy, the presence of detectable serum PSA levels allows to detect tumor recurrence even before any other diagnostic investigation (radiological or scintigraphical) becomes able to document it ("serological" disease). Unfortunately, increasing serum PSA levels do not reveal whether a patient is affected by local relapse or by metastases, with obvious repercussion for the therapeutic choice. Clinical examination of the patient, together with random and echoguided biopsies of the vesico-urethral anastomosis, do not reveal all cases of local recurrence. Ongoing study are evaluating other diagnostic tools in the monitoring patients after radical prostatectomy, such as the serum chromogranin A, the reverse transcriptase-polymerase chain reaction for PSA and prostate specific membrane antigen (PSMA), the Positron Emission Tomography and the immunoscintigraphy with radiolabeled monoclonal antibody directed toward the PSMA.