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.

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.

PSMA-PET- and MRI-Based Focal Dose Escalated Radiation Therapy of Primary Prostate Cancer: Planned Safety Analysis of a Nonrandomized 2-Armed Phase 2 Trial (ARO2020-01).

PURPOSE: The bicentric HypoFocal phase 2 trial investigates the implementation of molecular imaging with positron-emission tomography targeting prostate-specific membrane antigen (PSMA-PET) into modern focal dose-escalation radiation therapy (RT) concepts in 2 nonrandomized arms. We present the planned safety analysis after 6 months of follow-up. MATERIALS AND METHODS: Intermediate- and high-risk localized primary prostate cancer patients staged with multiparametric magnet resonance tomography and PSMA-PET were either treated with focal dose-escalated moderately hypofractionated RT (arm A) or single fraction high-dose-rate brachytherapy followed by external beam RT (arm B). PSMA-PET was used in addition to primary prostate cancer to define the intraprostatic gross tumor volume. Gastrointestinal and genitourinary toxicities were assessed according to Common Toxicity Criteria for Adverse Events (version 5.0) criteria. International Prostate Symptom Score was measured and quality of life assessed with European Organisation for Research and Treatment of Cancer questionnaires QLQ-PR25/-PR30. We enrolled 25 patients in each study arm. RESULTS: The implementation of PET-information led to large median volumes for dose escalation: 10.2 mL in arm A and 6.8 mL in Arm B. RT dose-escalation was feasible in all patients of arm A with up to 75 Gy (20 fractions) and in 23 patients with up to 19 Gy (1 fraction) in arm B. Toxicities, International Prostate Symptom Scores, and European Organisation for Research and Treatment of Cancer quality of life scores were not significantly different between baselines and 6 months follow-up in both arms. No grade 3 toxicities were observed at 6 months follow-up. CONCLUSIONS: This is the first prospective data supporting the feasibility of PSMA-PET-implementation into definitive focal dose-escalated RT. Patients maintained a good quality of life and a low toxicity profile after 6 months of follow-up.