Simona Presutti
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Research Subjects
Simona Presutti has a total of 49 co-authors. Here are the top co-authors by number of shared publications:
- Angelo Totaro
Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy
3 shared publications - Carlo Gandi
Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy
3 shared publications - Filippo Gavi
Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy
3 shared publications - Francesco Rossi
Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy
3 shared publications - Bernardo Rocco
Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli, 00168 Rome, Italy
2 shared publications - Enrico Panio
Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy
2 shared publications
Latest Publications
- Open Access
Early Postoperative Outcomes with the Toumai® Surgical System for Robot-Assisted Radical Prostatectomy: A Prospective Comparative Study with da Vinci®
Background: Prostate cancer (PCa) imposes a substantial global health burden, with robot-assisted radical prostatectomy (RARP) established as the gold standard for localized disease. While da Vinci® Xi maintains market dominance, Toumai® MT-1000 offers a potentially cost-competitive alternative lacking prospective validation. Objective: To evaluate perioperative safety, oncologic quality (primary endpoint: positive surgical margins), early functional recovery (continence), and surgeon learning curve between Toumai® MT-1000 (T-RARP) and da Vinci® Xi RARP (DV-RARP) performed in high-volume European practice. Materials and Methods: This is a prospective single-center comparative study carried out at Policlinico Gemelli, Rome (May–November 2025), enrolling 80 patients with localized or locally advanced PCa, elected for radical prostatectomy and casually allocated to receive surgery with Toumai or the da Vinci robotic platform. The primary endpoint was the comparison of positive surgical margin (PSM) rates. Secondary endpoints included the comparison of operative time (skin-to-skin), estimated blood loss, length of hospital stay, 45-day postop outcomes, specifically Clavien–Dindo complications, urinary continence recovery (0–1 pad/day), and IIEF-5 scores. Learning curve was evaluated through the cumulative summation (CUSUM) analysis of operative times and linear regression of operative times (n = 80 cases). The analyses used STATA 19 with two-sided tests at p < 0.05 significance. Results: Baseline characteristics showed balance between cohorts (p > 0.05 for most covariates). Perioperative outcomes proved equivalent: median operative time (OT) was 192.5 min (IQR 165–230) for Toumai® versus 183.5 min (IQR 147–225) for da Vinci® Xi (p = 0.38); estimated blood loss (EBL) was 150 mL in both groups (p = 0.87); length of hospital stay (LOS) was 2 days in both groups (p = 0.92). PSM rates were identical at 17.5% (p = 0.79). Continence recovery reached 72.5% versus 80% (p = 0.43). Complications (Clavien–Dindo ≥ II) occurred in 7.5% versus 12.5% of cases (p = 0.45). The CUSUM analysis demonstrated operative time proficiency after only four procedures; operative time regression showed no significant trend (p = 0.38). Conclusions: Toumai® MT-1000 demonstrates similar performance to da Vinci® Xi across different RARP quality metrics, with no detectable learning curve for surgeons previously experienced with da Vinci. These findings support a safe integration of cost-effective platforms into clinical practice, pending multicenter randomized confirmation.
Open AccessEarly Postoperative Outcomes with the Toumai® Surgical System for Robot-Assisted Radical Prostatectomy: A Prospective Comparative Study with da Vinci®
Background: Prostate cancer (PCa) imposes a substantial global health burden, with robot-assisted radical prostatectomy (RARP) established as the gold standard for localized disease. While da Vinci® Xi maintains market dominance, Toumai® MT-1000 offers a potentially cost-competitive alternative lacking prospective validation. Objective: To evaluate perioperative safety, oncologic quality (primary endpoint: positive surgical margins), early functional recovery (continence), and surgeon learning curve between Toumai® MT-1000 (T-RARP) and da Vinci® Xi RARP (DV-RARP) performed in high-volume European practice. Materials and Methods: This is a prospective single-center comparative study carried out at Policlinico Gemelli, Rome (May–November 2025), enrolling 80 patients with localized or locally advanced PCa, elected for radical prostatectomy and casually allocated to receive surgery with Toumai or the da Vinci robotic platform. The primary endpoint was the comparison of positive surgical margin (PSM) rates. Secondary endpoints included the comparison of operative time (skin-to-skin), estimated blood loss, length of hospital stay, 45-day postop outcomes, specifically Clavien–Dindo complications, urinary continence recovery (0–1 pad/day), and IIEF-5 scores. Learning curve was evaluated through the cumulative summation (CUSUM) analysis of operative times and linear regression of operative times (n = 80 cases). The analyses used STATA 19 with two-sided tests at p < 0.05 significance. Results: Baseline characteristics showed balance between cohorts (p > 0.05 for most covariates). Perioperative outcomes proved equivalent: median operative time (OT) was 192.5 min (IQR 165–230) for Toumai® versus 183.5 min (IQR 147–225) for da Vinci® Xi (p = 0.38); estimated blood loss (EBL) was 150 mL in both groups (p = 0.87); length of hospital stay (LOS) was 2 days in both groups (p = 0.92). PSM rates were identical at 17.5% (p = 0.79). Continence recovery reached 72.5% versus 80% (p = 0.43). Complications (Clavien–Dindo ≥ II) occurred in 7.5% versus 12.5% of cases (p = 0.45). The CUSUM analysis demonstrated operative time proficiency after only four procedures; operative time regression showed no significant trend (p = 0.38). Conclusions: Toumai® MT-1000 demonstrates similar performance to da Vinci® Xi across different RARP quality metrics, with no detectable learning curve for surgeons previously experienced with da Vinci. These findings support a safe integration of cost-effective platforms into clinical practice, pending multicenter randomized confirmation.
- Open Access
Liquid Biopsy in Non-Metastatic Prostate Cancer: Clinical Evidence and Future Directions
Background and Objective: Liquid biopsy has transformed the management of advanced prostate cancer, yet its clinical role in non-metastatic disease remains uncertain. Conventional biomarkers such as PSA, imaging, and pathology have limited ability to capture minimal residual disease and biological aggressiveness. The objective of this review was to critically evaluate the current evidence on circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in non-metastatic prostate cancer, focusing on feasibility, prognostic value, and potential clinical applications. Methods: A narrative review of PubMed-indexed original studies evaluating liquid biopsy in clinically localized or non-metastatic prostate cancer was performed. Eligible studies included patients treated with curative-intent local therapy or experiencing biochemical recurrence without radiologic metastases. Study designs were predominantly prospective or retrospective observational cohorts. Liquid biopsy analytes included CTCs and ctDNA assessed from peripheral blood plasma using EpCAM-based enrichment, targeted next-generation sequencing, whole-genome sequencing, or ultra-sensitive tumor-informed assays. Primary outcomes included detection rates, associations with clinicopathologic features, biochemical recurrence, metastasis-free survival, and overall survival. Key Findings and Limitations: Across 11 studies, CTC detection using EpCAM-based platforms was infrequent in localized disease and biochemical recurrence and showed limited prognostic value (10–11% in preoperative settings). In contrast, ctDNA was detectable in a minority of patients but consistently identified biologically aggressive disease and a higher risk of recurrence when present, particularly using tumor-informed ultra-sensitive assays. Limitations include low detection rates, heterogeneous methodologies, small sample sizes, and predominantly exploratory study designs. Conclusions and Clinical Implications: Currently, its most promising application is not broad screening, but as a selective, biology-driven tool for detecting minimal residual disease and refining risk assessment. CtDNA acts as a biological risk modifier, potentially guiding the escalation or de-escalation of adjuvant therapy. However, prospective biomarker-driven trials are required to validate these strategies before routine clinical implementation.
Open AccessLiquid Biopsy in Non-Metastatic Prostate Cancer: Clinical Evidence and Future Directions
Background and Objective: Liquid biopsy has transformed the management of advanced prostate cancer, yet its clinical role in non-metastatic disease remains uncertain. Conventional biomarkers such as PSA, imaging, and pathology have limited ability to capture minimal residual disease and biological aggressiveness. The objective of this review was to critically evaluate the current evidence on circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in non-metastatic prostate cancer, focusing on feasibility, prognostic value, and potential clinical applications. Methods: A narrative review of PubMed-indexed original studies evaluating liquid biopsy in clinically localized or non-metastatic prostate cancer was performed. Eligible studies included patients treated with curative-intent local therapy or experiencing biochemical recurrence without radiologic metastases. Study designs were predominantly prospective or retrospective observational cohorts. Liquid biopsy analytes included CTCs and ctDNA assessed from peripheral blood plasma using EpCAM-based enrichment, targeted next-generation sequencing, whole-genome sequencing, or ultra-sensitive tumor-informed assays. Primary outcomes included detection rates, associations with clinicopathologic features, biochemical recurrence, metastasis-free survival, and overall survival. Key Findings and Limitations: Across 11 studies, CTC detection using EpCAM-based platforms was infrequent in localized disease and biochemical recurrence and showed limited prognostic value (10–11% in preoperative settings). In contrast, ctDNA was detectable in a minority of patients but consistently identified biologically aggressive disease and a higher risk of recurrence when present, particularly using tumor-informed ultra-sensitive assays. Limitations include low detection rates, heterogeneous methodologies, small sample sizes, and predominantly exploratory study designs. Conclusions and Clinical Implications: Currently, its most promising application is not broad screening, but as a selective, biology-driven tool for detecting minimal residual disease and refining risk assessment. CtDNA acts as a biological risk modifier, potentially guiding the escalation or de-escalation of adjuvant therapy. However, prospective biomarker-driven trials are required to validate these strategies before routine clinical implementation.
- 1 April 2025
- Published by Edizioni Minerva Medica in Minerva Urology and Nephrology
- Vol. 77 (2) , 152-155
BRCA2 and genetic mutations in prostate cancer: an updated practical guide on "when and how" testing across international guidelines
Article: BRCA2 and genetic mutations in prostate cancer: an updated practical guide on “when and how” testing across international guidelines - Minerva Urology and Nephrology 2025 April;77(2):152-5 - Minerva Medica - Journals
- 1 April 2025
- Published by Edizioni Minerva Medica in Minerva Urology and Nephrology
- Vol. 77 (2) , 152-155
BRCA2 and genetic mutations in prostate cancer: an updated practical guide on "when and how" testing across international guidelines
Article: BRCA2 and genetic mutations in prostate cancer: an updated practical guide on “when and how” testing across international guidelines - Minerva Urology and Nephrology 2025 April;77(2):152-5 - Minerva Medica - Journals
- Open Access
- 16 November 2024
- Published by MDPI AG in Journal of Clinical Medicine
- Vol. 13 (22) , 6910
Hugo™ Versus daVinci™ Robot-Assisted Radical Prostatectomy: 1-Year Propensity Score-Matched Comparison of Functional and Oncological Outcomes
Background/Objectives: A comprehensive comparison of intraoperative, oncological, and functional outcomes of RARP performed with different robotic surgical platforms is critically needed. Our aim is to compare the oncological and functional outcomes of RARP performed using the novel Hugo™ RAS system with those from the daVinci system, the reference standard, at a high-volume robotic center, with an extended follow-up period (one year). Methods: We analyzed the data of 400 patients undergoing RARP ± pelvic lymph node dissection between 2021 and 2023, using propensity score (PS) matching to correct for treatment selection bias. All procedures were performed by three surgeons with HugoTM RAS or daVinci. This analysis extends the follow-up period to 1 year, focusing on specific functional and oncological outcomes, building on our previous 3-month evaluation of perioperative outcomes. The primary outcome was the trifecta rate, defined as freedom from biochemical recurrence, continence, and erectile function recovery. Secondary outcomes included detailed assessments of oncological outcomes (PSA levels) and functional outcomes (continence and erectile function). Results: The propensity score-matched cohort included 99 matched pairs (198 patients), balanced for all covariates. No significant differences were found in trifecta rates between the two platforms at 1-year follow-up (Hugo: 25.25%, daVinci: 27.27%, p = 0.743). Both groups showed improved trifecta rates when considering only nerve-sparing procedures (Hugo: 36.84%, daVinci: 35.59%, p = 0.889). Continence rates were similar (Hugo: 87.9%, daVinci: 89.9%, p = 0.327), as were the undetectable PSA rates (Hugo: 92.9%, daVinci: 88.8%, p = 0.158). Also, the erectile function recovery rate did not differ significantly between the groups. Conclusions: This is the first study comparing 1-year functional and oncological outcomes of RARP performed with Hugo™ RAS and daVinci surgical robotic systems using PS matching. Functional and oncological outcomes of RARP were comparable between the two robotic platforms. These findings confirm that the transition to the Hugo™ platform does not compromise surgical proficiency or patient outcomes, even if further long-term studies are necessary to confirm these results.
- 16 November 2024
- Published by MDPI AG in Journal of Clinical Medicine
- Vol. 13 (22) , 6910
Open AccessHugo™ Versus daVinci™ Robot-Assisted Radical Prostatectomy: 1-Year Propensity Score-Matched Comparison of Functional and Oncological Outcomes
Background/Objectives: A comprehensive comparison of intraoperative, oncological, and functional outcomes of RARP performed with different robotic surgical platforms is critically needed. Our aim is to compare the oncological and functional outcomes of RARP performed using the novel Hugo™ RAS system with those from the daVinci system, the reference standard, at a high-volume robotic center, with an extended follow-up period (one year). Methods: We analyzed the data of 400 patients undergoing RARP ± pelvic lymph node dissection between 2021 and 2023, using propensity score (PS) matching to correct for treatment selection bias. All procedures were performed by three surgeons with HugoTM RAS or daVinci. This analysis extends the follow-up period to 1 year, focusing on specific functional and oncological outcomes, building on our previous 3-month evaluation of perioperative outcomes. The primary outcome was the trifecta rate, defined as freedom from biochemical recurrence, continence, and erectile function recovery. Secondary outcomes included detailed assessments of oncological outcomes (PSA levels) and functional outcomes (continence and erectile function). Results: The propensity score-matched cohort included 99 matched pairs (198 patients), balanced for all covariates. No significant differences were found in trifecta rates between the two platforms at 1-year follow-up (Hugo: 25.25%, daVinci: 27.27%, p = 0.743). Both groups showed improved trifecta rates when considering only nerve-sparing procedures (Hugo: 36.84%, daVinci: 35.59%, p = 0.889). Continence rates were similar (Hugo: 87.9%, daVinci: 89.9%, p = 0.327), as were the undetectable PSA rates (Hugo: 92.9%, daVinci: 88.8%, p = 0.158). Also, the erectile function recovery rate did not differ significantly between the groups. Conclusions: This is the first study comparing 1-year functional and oncological outcomes of RARP performed with Hugo™ RAS and daVinci surgical robotic systems using PS matching. Functional and oncological outcomes of RARP were comparable between the two robotic platforms. These findings confirm that the transition to the Hugo™ platform does not compromise surgical proficiency or patient outcomes, even if further long-term studies are necessary to confirm these results.