A prospective study on inter-operator variability in semi-robotic software-based MRI/TRUS-fusion targeted prostate biopsies.

PURPOSE: Magnetic resonance imaging (MRI)/ultrasound-fusion prostate biopsy (FB) comprises multiple steps each of which can cause alterations in targeted biopsy (TB) accuracy leading to false-negative results. The aim was to assess the inter-operator variability of software-based fusion TB by targeting the same MRI-lesions by different urologists. METHODS: In this prospective study, 142 patients eligible for analysis underwent software-based FB. TB of all lesions (n = 172) were carried out by two different urologists per patient (n = 31 urologists). We analyzed the number of mismatches [overall prostate cancer (PCa), clinically significant PCa (csPCa) and non-significant PCa (nsPCa)] between both performed TB per patient. In addition we evaluated factors contributing to inter-operator variability by uni- and multivariable analyses. RESULTS: In 11.6% of all MRI-lesions (10.6% of all patients) there was a mismatch between TB1 and TB2 in terms of overall prostate cancer (PCa detection. Regarding csPCa, patient-based mismatch occurred in 14.8% (n = 21). Overall PCa and csPCa detection rate of TB1 and TB2 did not differ significantly on a per-patient and per-lesion level. Analyses revealed a smaller lesion size as predictive for mismatches (OR 9.19, 95% CI 2.02-41.83, p < 0.001). CONCLUSION: Reproducibility and precision of targeting particularly small lesions is still limited although using software-based FB. Further improvements in image-fusion, segmentation, needle-guidance, and automatization are necessary.

Medium-term Oncological Efficacy and Patient-reported Outcomes After Focal High-intensity Focused Ultrasound: The FOXPRO Trial.

BACKGROUND: Multiparametric magnetic resonance imaging (mpMRI)/transrectal ultrasound (TRUS) fusion-guided high-intensity focused ultrasound (HIFU) is a focal treatment option for MRI-visible localized prostate cancer (PCa). High-quality evidence regarding the clinical efficacy remains limited. OBJECTIVE: To assess medium-term oncological efficacy along with patient-reported outcome measures (PROMs). DESIGN, SETTING, AND PARTICIPANTS: This prospective single-center cohort study was performed from 2014 to 2020. Patients with primary International Society of Urological Pathologists (ISUP) grade group (GG) ≤2 by combined MRI/TRUS fusion and systematic prostate biopsy and prostate-specific antigen (PSA) <10 ng/ml were included. INTERVENTION: MRI/TRUS fusion-guided focal HIFU therapy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the cancer-free rate of the HIFU-treated lesion by biopsy after 1 yr. Secondary endpoints included salvage treatment-free survival (STFS), metastasis-free survival (MFS), overall survival (OS), and PROMs according to International Consortium for Health Outcomes Measurement recommendations. RESULTS AND LIMITATIONS: Fifty patients were included (median [range] age 68 [48-80] yr; median PSA 6.5 [1.2-9.9] ng/ml; GG 1 54% [n = 27], and GG 2 46% [n = 23]). The median (range) PSA decrease from baseline to 12 mo was 51% (35.9-72.7%). In total, 37/50 patients (74%) underwent a 1-yr biopsy. PCa was detected in 23 patients (46%; GG 1 20% [n = 10]; GG >1 26% [n = 13]; infield 40% [n = 20]). At a median follow-up of 42 (13-73) mo, PCa was detected in 30 men (60%). Among all patients, 19 (38%) underwent salvage treatments (median [95% confidence interval] STFS 53 [44.3-61.7] mo). MFS and OS were 100% and 98%, respectively. The Expanded Prostate Cancer Index Composite-26 sexual domain decreased by 20.8 points (p = 0.372). CONCLUSIONS: MRI/TRUS-guided focal HIFU therapy results in complete cancer ablation in only half of the treated patients after 1 yr, with further recurrences at medium-term follow-up. A decline of potency occurs in a subset of patients. PATIENT SUMMARY: Focal image-guided high-intensity focused ultrasound therapy controls cancer in one of two patients. Its impact on urinary continence and erectile function is low.

A Matched-pair Analysis Comparing Systematic Prostate Biopsy by Conventional Transrectal Ultrasound-guidance Versus Software-based Predefined 3D-Guidance.

OBJECTIVE: To compare software-based three-dimensional-guided systematic prostate biopsy (3D-GSB) with conventional transrectal ultrasound-guided systematic biopsy (TGSB) regarding prostate cancer (PCa) detection rates (CDR). METHODS: In total, 956 patients (200 TGSB patients and 756 3D-GSB patients) without prior positive biopsies and with a prostate-specific antigen value ≤20 ng/ml were eligible for analysis. TGSB and 3D-GSB cases were matched in a 1:1 ratio using propensity score matching with age, prostate-specific antigen, prostate volume, previous biopsy status, and suspicious palpatory finding as confounders. 3D-GSB was conducted with the semi-robotic prostate fusion-biopsy system Artemis. For each patient in both groups, SB was conducted in a similar pattern with 12 cores. All cores in 3D-GSB were automatically planned and mapped on a 3D-model as well as on the real-time transrectal ultrasound imaging. Primary end points were the clinically significant (cs) and overall CDR. Secondary end point was the cancer-positive core rate. RESULTS: After matching, the csCDR was not significantly different between the 3D-GSB and the TGSB groups (33.3% vs 28.8%, P = .385). Overall CDR was significantly higher for 3D-GSB compared to TGSB (55.6% vs 39.9%, P = .002). 3D-GSB detected significantly more non-significant PCa than TGSB (22.2% vs 11.1%, P = .004). In patients with PCa, the number of cancer-positive SB cores was significantly higher by TGSB (42% vs 25%, P < .001). CONCLUSION: 3D-GSB was associated with a higher CDR than TGSB. However, no significant difference was shown in detection of csPCa between both techniques. Therefore, currently, 3D-GSB does not appear to add value to conventional TGSB.