Aquablation versus HoLEP in patients with benign prostatic hyperplasia: a comparative prospective non-randomized study.

PURPOSE: The question of best surgical treatment for lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH) remains controversial. We compared the outcomes of aquablation and holmium laser enucleation of the prostate ("HoLEP") in a prospective cohort. METHODS: Patients with BPH underwent aquablation or HoLEP according to their preference between June 2020 and April 2022. Prostate volume ("PV"), laboratory results, postvoid residual volume, uroflowmetry, IPSS, ICIQ-SF, MSHQ-EjD, EES and IIEF were evaluated preoperatively and at three, six and 12 months postoperatively. We also analyzed perioperative characteristics and complications via the Clavien Dindo ("CD") classification. RESULTS: We included 40 patients, 16 of whom underwent aquablation and 24 HoLEP. Mean age was 67 years (SD 7.4). Baseline characteristics were balanced across groups, except the HoLEP patients' larger PV. IPSS fell from 20.3 (SD 7.1) at baseline to 6.3 (SD 4.2) at 12 months (p < 0.001) without differences between aquablation and HoLEP. HoLEP was associated with shorter operation time (59.5 (SD 18.6) vs. 87.2 (SD 14.8) minutes, p < 0.001) and led to better PV reduction over all timepoints. At three months, aquablation's results were better regarding ejaculatory (p = 0.02, MSHQ-EjD) and continence function (p < 0.001, ICIQ-SF). Beyond three months, erectile, ejaculatory, continence function and LUTS reduction did not differ significantly between aquablation and HoLEP. CD ≥ grade 3b complications were noted in six patients in aquablation group while only one in HoLEP group (p = < 0.01). CONCLUSIONS: While aquablation revealed temporary benefits regarding ejaculation and continence at three months, HoLEP was superior concerning operation time, the safety profile and volumetric results.

Assessment of Patient Risk Profiles by a Male Sexual Health Direct-to-Consumer Prescription Platform: A Cross-Sectional Study.

Background: Direct-to-consumer (DTC) online prescription platforms (OPP) for sexual health represent a potential paradigm shift in the diagnosis and treatment for sexual dysfunctions in the way men seek care. Knowledge of patients' risk profile using these platforms is limited. Aim: To assess risk profiles of patients reaching out to health care professionals through their DTC. Methods: Anonymized data originally collected between February 2021 to May 2022 by a DTC platform in the men's health care space were retrospectively analyzed. Data included the content of patient requests through a communication function, as well as the corresponding responses by the attending physician on staff. Each request was then assessed by two independent urologists and categorized by the level of the risk profile as well as the need to refer the patient to further medical evaluation. Results: Of 585 patient requests, 531 (90.8%) were classified as low risk. In the high-risk group, 32 patients were recommended to schedule an urgent appointment at a specialist. Only three patients (0.5%) were advised to seek emergency care. The overall referral rate for both risk groups was 52.3%. The requests of 279 patients (47.7%) were assessed as digitally treatable. Almost all patients who were digitally treatable were low risk. Side effects accounted for only 9.6% of all requests in the low-risk group, compared with 46.3% in the high-risk group. Conclusion: Overall, low-risk levels in the requests of patients using a DTC platform were reported, with almost half of them suitable to be solved digitally, whereas the other half required referral to an in-person specialist.

Ex vivo γH2AX assay for tumor radiosensitivity in primary prostate cancer patients and correlation with clinical parameters.

BACKROUND: Accurate surrogate parameters for radio resistance are warranted for individualized radiotherapy (RT) concepts in prostate cancer (PCa). The purpose of this study was to assess intertumoral heterogeneity in terms of radio resistance using an ex-vivo γH2AX assay after irradiation of prostate biopsy cores and to investigate its correlation with clinical features of respective patients as well as imaging and genomic features of tumor areas. METHODS: Twenty one patients with histologically-proven PCa and pre-therapeutic multiparametric resonance imaging and prostate-specific membrane antigen positron emission tomography were included in the study. Biopsy cores were collected from 26 PCa foci. Residual γH2AX foci were counted 24 h after ex-vivo irradiation (with 0 and 4 Gy) of biopsy specimen and served as a surrogate for radio resistance. Clinical, genomic (next generation sequencing) and imaging features were collected and their association with the radio resistance was studied. RESULTS: In total 18 PCa lesions from 16 patients were included in the final analysis. The median γH2AX foci value per PCa lesion was 3.12. According to this, the patients were divided into two groups (radio sensitive vs. radio resistant) with significant differences in foci number (p < 0.0001). The patients in the radio sensitive group had significantly higher prostate specific antigen serum concentration (p = 0.015), tumor areas in the radio sensitive group had higher SUV (standardized uptake values in PSMA PET)-max and -mean values (p = 0.0037, p = 0.028) and lower ADC (apparent diffusion coefficient-mean values, p = 0.049). All later parameters had significant (p < 0.05) correlations in Pearson's test. One patient in the radio sensitive group displayed a previously not reported loss of function frameshift mutation in the NBN gene (c.654_658delAAAAC) that introduces a premature termination codon and results in a truncated protein. CONCLUSION: In this pilot study, significant differences in intertumoral radio resistance were observed and clinical as well as imaging parameters may be applied for their prediction. After further prospective validation in larger patient cohorts these finding may lead to individual RT dose prescription for PCa patients in the future.

Digital Real-world Data Suggest Patient Preference for Tadalafil over Sildenafil in Patients with Erectile Dysfunction.

BACKGROUND: Erectile dysfunction (ED) is a major care problem worldwide. Tadalafil and sildenafil are the two most common phosphodiesterase-5 inhibitors (PDE5is) used to treat ED. OBJECTIVE: This study aimed to evaluate patient data of a large online prescription platform (OPP), specifically analyzing preference for tadalafil over sildenafil. DESIGN, SETTING, AND PARTICIPANTS: Data from a prospectively collected German OPP were retrospectively analyzed. This dataset included patients with a history of taking one or both substances (n = 26 821). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: ED patient baseline characteristics were derived from medical questionnaires for PDE5i prescriptions between May 2019 and May 2020. Order behavior was analyzed in patients who ordered both substances over time. We applied Kruskal-Wallis tests, χ² tests, and fisher's exact tests for statistical analysis. RESULTS AND LIMITATIONS: Baseline characteristics were comparable for both PDE5is in patients with a median age of 49 yr (sildenafil [interquartile range {IQR} 38-57]; tadalafil [IQR 39-56]), a median body mass index (BMI) of 26 kg/m² (sildenafil [IQR 24.54-29.03]; tadalafil [IQR 24.49-28.69]), ED onset time of >12 mo (sildenafil [87%]; tadalafil [88%]), and the presence of morning erections (sildenafil [62%]; tadalafil [61%]). Tadalafil prescriptions increased significantly from 30% (first order) to 80% (last order) in patients who had already tested both drugs. Patients with age ≤40 yr, BMI ≤25 kg/m², and sustained morning erections preferred tadalafil to sildenafil. CONCLUSIONS: Using database information from an OPP, preference for tadalafil was shown for patients who had tested both PDE5is. This preference was particularly pronounced in patients with age ≤40 yr, BMI ≤25 kg/m², and sustained morning erections. A well-managed OPP can be used for research on more complex health services. PATIENT SUMMARY: Analysis of large online prescription platforms provide the benefit of identifying young treatment-naïve patients with early-stage disease, which is highlighted by the fact that about two-thirds of our patients analyzed still maintained spontaneous morning erections. Patients who had tested tadalafil once developed preference for this drug.

99mTc-labelled PSMA ligand for radio-guided surgery in nodal metastatic prostate cancer: proof of principle.

PURPOSE: Intraoperative identification of prostate cancer (PCa) lymph node (LN) metastases (LNM) detected by preoperative PSMA PET/CT may be facilitated by PSMA radio-guided surgery (RGS) with use of a γ-probe. Earlier we demonstrated excellent performance of the 111In-labelled PSMA ligand DKFZ-617 ([111In]In-PSMA-617) in RGS for ex situ distinction of LN vs LNM at lymphadenectomy (LA) at a single LN level. In comparison with indium-111, technetium-99m has better physical properties for γ-probe measurements, better availability and lower radiation exposure for patients and medical personnel. Against this background, we evaluated the uptake of 99mTc-PSMA-I&S ligand at the level of single LN and its power to discriminate between unaffected LN and LNM. METHODS: Six patients with PCa with the suspicion of LNM on preoperative PSMA-PET/CT underwent [99mTc]Tc-PSMA-I&S RGS (4 salvage LA, 2 primary LA) with intravenous injection of [99mTc]Tc-PSMA-I&S 24 h prior to surgery. Resected samples were isolated manually aiming at the level of single LN. Uptake measurements were done ex situ with a high-purity germanium detector. Receiver operating characteristic (ROC) analysis was performed based on [99mTc]Tc-PSMA-I&S uptake expressed as lean body mass standard uptake value (SUL). RESULTS: Separation of the tissue samples from 73 subregions resulted in 498 single samples. After final histopathology 356 LN, 160 LNM und 11 non-nodal PCa samples were identified. Median SUL of tumor-free samples (0.26) and samples with cancer (3.5) was significantly different (p < 0.0001). ROC analysis revealed an area under the curve (AUC) of 0.917 (95% CI 0.89-0.95). Using a SUL cutoff of 1.1, sensitivity, specificity, positive predictive value, and negative predictive values were 76.6%, 94.4%, 89.4% and 86.9%. CONCLUSION: Ex situ analysis of [99mTc]Tc-PSMA-I&S uptake at single LN level showed good diagnostic performance for the ex situ distinction of tumor-bearing vs tumor-free LN during RGS.

Results from extended lymphadenectomies with [111In]PSMA-617 for intraoperative detection of PSMA-PET/CT-positive nodal metastatic prostate cancer.

PURPOSE: Identification of suspicious PSMA-PET/CT-positive lymph node (LN) metastases (LNM) from prostate cancer (PCa) during lymphadenectomy (LA) is challenging. We evaluated an 111In-labelled PSMA ligand (DKFZ-617, referred to as [111In]PSMA-617) as a γ-emitting tracer for intraoperative γ-probe application for resected tissue samples in PCa patients. Forty-eight hours prior to LA, [111In]PSMA-617 was administered intravenously in 23 patients with suspected LNM on PSMA-PET/CT (n = 21 with biochemical relapse, n = 2 at primary therapy). Resected tissue samples (LN, LNM and fibrofatty tissue) were measured ex situ by a γ-probe expressed as counts per second (CPSnorm). [111In]PSMA-617 tissue sample uptake was measured by a germanium detector for verification and calculated as %IAlbm (percent injected activity per kilogram lean body mass at time of surgery). Based on a clinical requirement for a specificity > 95%, thresholds for both ex situ measurements were chosen accordingly. Correlation of the results from PET/CT, γ-probe and germanium detector with histopathology was done. RESULTS: Eight hundred sixty-four LNs (197 LNM) were removed from 275 subregions in 23 patients, on average 8.6 ± 14.9 LNM per patient. One hundred four of 275 tissue samples showed cancer. Median γ-probe and germanium detector results were significantly different between tumour-affected (33.5 CPSnorm, 0.71 %IAlbm) and tumour-free subregions (3.0 CPSnorm, 0.03 %IAlbm) (each p value < 0.0001). For the chosen γ-probe cut-off (CPSnorm > 23) and germanium detector cut-off (%IAlbm > 0.27), 64 and 74 true-positive and 158 true-negative samples for both measurements were identified. Thirty-nine and 30 false-negative and 6 and 5 false-positive tissue samples were identified by γ-probe and germanium detector measurements. CONCLUSION: [111In]PSMA-617 application for LA is feasible in terms of an intraoperative real-time measurement with a γ-probe for detection of tumour-affected tissue samples. γ-probe results can be confirmed by precise germanium detector measurements and were significantly different between tumour-affected and tumour-free samples.