Perioperative, Oncological, and Functional Outcomes Between Robot-Assisted Laparoscopic Prostatectomy and Open Radical Retropubic Prostatectomy: A Randomized Clinical Trial.

PURPOSE: Limited high-quality studies have compared robot-assisted laparoscopic prostatectomy (RALP) vs open retropubic radical prostatectomy. We sought to compare their postoperative outcomes in a randomized setting. MATERIALS AND METHODS: In a single center, 354 men with newly diagnosed prostate cancer were assessed for eligibility; 342 were randomized (1:1). The primary outcome was 90-day complication rates. Functional outcomes and quality of life were assessed over 18 months, and oncological outcomes, biochemical recurrence-free survival, and additional treatment over 36 months. RESULTS: From 2014 to 18, 327 patients underwent surgery (retropubic radical prostatectomy = 156, RALP = 171). Complications occurred in 27 (17.3%) vs 19 (11.1%; P = .107). Patients undergoing RALP experienced lower median bleeding (250.0 vs 719.5 mL; P < .001) and shorter hospitalization time. Urinary EPIC (Expanded Prostate Cancer Index Composite) median scores were better for RALP over 18 months, with higher continence rate at 3 months (80.5% vs 64.7%; P = .002), 6 months (90.1% vs 81.6%; P = .036) and 18 months (95.4% vs 78.8%; P < .001). Sexual EPIC and Sexual Health Inventory for Men median scores were higher with RALP up to 12 months, while the potency rate was superior at 3 months (23.9% vs 5.3%; P = .001) and 6 months (30.6% vs 6.9%; P < .001). Quality of life over the 18 months and oncological outcomes over 36 months were not significantly different between arms. CONCLUSIONS: Complications at 90 days were similar. RALP showed superior sexual outcomes at 1 year, improved urinary outcomes at 18 months, and comparable oncological outcomes at 36 months. TRIAL REGISTRATION: Prospective Analysis of Robot-Assisted Surgery; NCT02292914. https://clinicaltrials.gov/ct2/show/NCT02292914?cond=NCT02292914&draw=2&rank=1.

Perioperative Morbidity of Radical Prostatectomy After Intensive Neoadjuvant Androgen Blockade in Men With High-Risk Prostate Cancer: Results of Phase II Trial Compared to a Control Group.

INTRODUCTION: Recent studies about intense neoadjuvant therapy followed by Radical Prostatectomy (RP) lack standardized criteria regarding surgical complications and comparison to a group of patients who underwent RP without the use of neoadjuvant therapy. The aim of this study is to describe and compare the perioperative complication rates. MATERIALS AND METHODS: This was a prospective, single-center phase II trial in patients with high-risk prostate cancer (HRPCa). The control group included HRPCa patients who underwent RP outside the clinical trial during the same study recruitment period. The interventional group was randomized (1:1) to receive neoadjuvant androgen deprivation therapy plus abiraterone with or without apalutamide followed by RP. Complications observed up to 30 days of surgery were classified based on the Clavien-Dindo classification. Uni- and multivariate analyses were carried out to assess predictive factors associated with perioperative complications. RESULTS: In total, 124 patients with HRPCa were underwent to RP between May 27, 2019 and August 6, 2021, including 61 patients in the intervention group and 63 patients in the control group. The general and major complications in the intervention group reached 29.6% and 6.6%, respectively, and 39.7% and 7.9% in the control group, respectively. There was no significant difference between groups. We observed 4.9% of thromboembolic event in the neoadjuvant group. CONCLUSIONS: There was no significant increase in morbidity rate in RP after intense neoadjuvant therapy. The association of intense androgen deprivation neoadjuvant therapy with RP and extended pelvic lymphadenectomy may increase the risk of a perioperative thromboembolic events.

Effectiveness of Intrarectal Povidone-iodine Cleansing Plus Formalin Disinfection of the Needle Tip in Decreasing Infectious Complications After Transrectal Prostate Biopsy: A Randomized Controlled Trial.

PURPOSE: Prostate biopsy is mostly performed through the transrectal route worldwide and infectious complications may occur in up to 7% of cases. Therefore, alternative strategies to decrease infectious complications are needed. Our aim was to evaluate the effectiveness of intrarectal povidone-iodine cleansing plus formalin disinfection of the needle tip in decreasing infectious complications after transrectal ultrasound guided prostate biopsy. MATERIALS AND METHODS: We conducted a prospective, single-center, phase III trial in patients undergoing transrectal ultrasound guided prostate biopsy randomized 1:1 to rectal mucosa cleansing with gauze soaked in 10% povidone-iodine solution wrapped around the gloved index finger and needle tip disinfection by immersion in a 10% formalin solution before each puncture vs control group. The primary end point was the rate of infectious complications defined as 1 or more of the following events: fever, urinary tract infection, or sepsis. RESULTS: Overall, 633 patients were randomized to the intervention group and 623 to the control group. The infectious complication rate was 3.9% in the intervention group and 6.4% in the control group (RR 0.61; 95% CI 0.36-0.99; P = .049). The rates of sepsis, urinary tract infection, and fever were 0.3% vs 0.5% (P = .646), 2.3% vs 4.1% (P = .071), and 1.3% vs 1.9% (P = .443), respectively. The positive urine culture rate was 5.2% in the intervention group and 9% in the control group (RR 0.57; P = .015). There was no statistically significant difference between the groups regarding the occurrence of noninfectious adverse events. CONCLUSIONS: Intrarectal povidone-iodine cleansing plus formalin disinfection of the biopsy needle tip was associated with a reduction in infectious complications after transrectal prostate biopsy.

miRNA and mRNA Expression Profiles Associated with Lymph Node Metastasis and Prognosis in Penile Carcinoma.

Penile cancer (PeC) is a rare disease, and no prognostic biomarkers have been adopted in clinical practice yet. The objective of the present study was to identify differentially expressed miRNAs (DEmiRs) and genes (DEGs) as potential biomarkers for lymph node metastasis and other prognostic factors in PeC. Tumor samples were prospectively obtained from 24 patients with squamous cell carcinoma of the penis. miRNA microarray analysis was performed comparing tumors from patients with inguinal lymph node metastatic and localized disease, and the results were validated by qRT-PCR. Eighty-three gene expression levels were also compared between groups through qRT-PCR. Moreover, DEmiRs and DEGs expression levels were correlated with clinicopathological variables, cancer-specific (CSS), and overall survival (OS). TAC software, TM4 MeV 4.9 software, SPSS v.25.0, and R software v.4.0.2 were used for statistical analyses. We identified 21 DEmiRs in microarray analysis, and seven were selected for validation. miR-744-5p and miR-421 were overexpressed in tissue samples of metastatic patients, and high expression of miR-421 was also associated with lower OS. We found seven DEGs (CCND1, EGFR, ENTPD5, HOXA10, IGF1R, MYC, and SNAI2) related to metastatic disease. A significant association was found between increased MMP1 expression and tumor size, grade, pathological T stage, and perineural invasion. Other genes were also associated with clinicopathological variables, CSS and OS. Finally, we found changes in mRNA-miRNA regulation that contribute to understanding the mechanisms involved in tumor progression. Therefore, we identified miRNA and mRNA expression profiles as potential biomarkers associated with lymph node metastasis and prognosis in PeC, in addition to disruption in mRNA-miRNA regulation during disease progression.

A Prospective, Randomized Trial Comparing the Outcomes of Open vs Laparoscopic Partial Nephrectomy.

PURPOSE: Partial nephrectomy is the standard treatment for renal tumors <7 cm, and the trend toward minimally invasive surgery has increased. However, data that could support its use and benefits are still lacking. MATERIALS AND METHODS: We conducted a prospective, randomized controlled trial comparing surgical, functional and oncologic outcomes in patients undergoing open partial nephrectomy (OPN) or laparoscopic partial nephrectomy (LPN). Randomization was 1:1 to OPN or LPN for the treatment of renal tumors <7 cm. The primary endpoint was surgical complications up to 90 days after surgery. Secondary outcomes were comparison of surgical, oncologic and functional results. RESULTS: We randomized 208 patients between 2012 and 2020 (110 with OPN vs 98 with LPN). Operative data showed no differences in operative time, warm ischemia time, estimated blood loss, transfusions or length of hospital stay. Zero ischemia was more frequent in the OPN (35.4% vs 15.5%, p=0.02). OPN was associated with more abdominal wall complications (31.2% vs 13.1%, p=0.004). Regarding oncologic outcomes, no differences were noted. The LPN group had less kidney function reduction at 3 (-5.2% vs -10%, p=0.04; CI 0.09 to 9.46) and 12 months after surgery (-0.8% vs -6.3%, p=0.02; CI 1.18 to 12.95), and a lower rate of downstaging on the chronic kidney disease classification at 12 months (14.1% vs 32.6%, p=0.006). CONCLUSIONS: Surgical and oncologic outcomes of LPN were similar to OPN. Minimally invasive surgery may provide better preservation of kidney function. More studies, especially those involving robotic surgery, are necessary to confirm our findings.

Case 297: Mucinous Adenocarcinoma of the Prostate.

History A 70-year-old man was referred to our institution with chronic obstructive urinary symptoms and constipation for 2 years before admission. His medical history was unremarkable. Outside laboratory tests revealed an elevated serum prostate-specific antigen level (21.7 ng/mL [normal range, 0.00-4.00 ng/mL]), and urinalysis results were negative. He was admitted for evaluation of possible prostate cancer. The patient reported no specific symptoms of infection and denied fever, dysuria, hematuria, and abdominal pain. He had no family history of prostate cancer. On physical examination, he was afebrile, and the digital rectal examination was not painful. These findings were evidence of an enlarged prostate and a hard multilobulated mass, which was palpable bilaterally. The urologic team performed MRI of the prostate.

Disruption of miRNA-mRNA Networks Defines Novel Molecular Signatures for Penile Carcinogenesis.

Penile cancer (PeC) carcinogenesis is not fully understood, and no biomarkers are reported in clinical practice. We aimed to investigate molecular signatures based on miRNA and mRNA and perform an integrative analysis to identify molecular drivers and pathways for PeC development. Affymetrix miRNA microarray was used to identify differentially expressed miRNAs (DEmiRs) comparing 11 tumoral tissues (TT) paired with non-neoplastic tissues (NNT) with further validation in an independent cohort (n = 13). We also investigated the mRNA expression of 83 genes in the total sample. Experimentally validated targets of DEmiRs, miRNA-mRNA networks, and enriched pathways were evaluated in silico. Eight out of 69 DEmiRs identified by microarray analysis were validated by qRT-PCR (miR-145-5p, miR-432-5p, miR-487b-3p, miR-30a-5p, miR-200a-5p, miR-224-5p, miR-31-3p and miR-31-5p). Furthermore, 37 differentially expressed genes (DEGs) were identified when comparing TT and NNT. We identified four downregulated DEmiRs (miR-30a-5p, miR-432-5p, miR-487b-3p, and miR-145-5p) and six upregulated DEGs (IL1A, MCM2, MMP1, MMP12, SFN and VEGFA) as potential biomarkers in PeC by their capacity of discriminating TT and NNT with accuracy. The integration analysis showed eight dysregulated miRNA-mRNA pairs in penile carcinogenesis. Taken together, our findings contribute to a better understanding of the regulatory roles of miRNAs and altered transcripts levels in penile carcinogenesis.

Case 297.

History A 70-year-old man was referred to our institution with chronic obstructive urinary symptoms and constipation for 2 years before admission. His medical history was unremarkable. Outside laboratory tests revealed an elevated serum prostate-specific antigen level (21.7 ng/mL [normal range, 0.00-4.00 ng/mL]), and urinalysis results were negative. He was admitted for evaluation of possible prostate cancer. The patient reported no specific symptoms of infection and denied fever, dysuria, hematuria, and abdominal pain. He had no family history of prostate cancer. On physical examination, he was afebrile, and the digital rectal examination was not painful. These findings were evidence of an enlarged prostate and a hard multilobulated mass, which was palpable bilaterally. The urologic team performed MRI of the prostate (Figs 1-4).

Robot-assisted simple prostatectomy: the evolution of a surgical technique

ABSTRACT Purpose: Enucleation of a large prostate is the best surgical choice for patients refractory to clinical treatment (1,2). Since the first robot-assisted simple prostatectomy (RASP) was described (3,4), some technical modifications (5-7) and different approaches to reach the adenoma have been proposed (8,9). The aim of this video is to demonstrate three different techniques of RASP. Materials and Methods: The first procedure begins with a transversal incision over the bladder neck, the second is a transvesical approach and the last one is a Retzius-sparing RASP. All techniques were performed with a vesico-urethral anastomosis. Results: Three patients underwent RASP, each one with a different approach. Patients presented mean age of 66±4.4 years, PSA baseline level of 7.8±3ng/mL, IPSS score of 17.7±4.5, maximum urine flow of 8.3±1.5mL/seg and 122.3±11.2cm3 of prostate volume. The mean operative time was 63±8 minutes, estimated blood loss of 106.7±11.5mL, prostate weight of the surgical specimen of 106.3±8 grams and 1 day of length of stay. No continuous bladder irrigation was required and there was no complication. The mean postoperative PSA and IPSS were 0.7±0.3ng/mL, 4.7±1.5. The maximum urine flow raised to 20±4.4mL/seg. Conclusions: RASP with vesico-urethral anastomosis allowed minimal blood loss, short length of stay and great functional outcomes. All the three approaches allowed to perform this technique in a safe way, while showing different alternatives to reach the adenoma.

Robot-assisted endoscopic inguinal lymphadenectomy: A review of current outcomes.

OBJECTIVE: To review the role of robot-assisted endoscopic inguinal lymphadenectomy (RAIL) in the management of penile cancer. METHODS: A PubMed search for all relevant publications regarding RAIL series up until August 2019 was performed using the keyword "robotic", "inguinal lymph node dissection", and "penile cancer". Weighted mean was calculated in the largest series for all outcomes using the number of patients included in each study as the weighting factor. RESULTS: We identified 23 articles, of note the three largest series that included 102, 27, and 20 RAIL in 51, 14, and 10 patients, respectively. Saphenous vein was spared in 88.93% of RAIL cases in these series and node yield was 11.42 per groin; 35.28% of patients had positive pathological nodes. The weighted mean of operative time was 87.98 min per RAIL and the estimated blood loss was 37.08 mL per patient. The mean length of hospital stay was 1.29 days and the drain was kept in place for 17.02 days; the major complication rate was only 5.31% in these series. The mean follow-up was 33.46 months with a recurrence-free survival of 96.33%. CONCLUSION: The literature regarding RAIL describes promising results, although it has shorter follow-up and higher costs when compared to historically series from the open approach. Initials series reported lower cutaneous complications compared to conventional approach, without compromising oncological outcomes. However, long-term results and larger trials are crucial to validate those findings.

Robot-assisted retroperitoneal lymphadenectomy: The state of art.

OBJECTIVE: To perform a narrative review about the role of robot-assisted retroperitoneal lymphadenectomy (R-RPLND) in the management of testicular cancer. METHODS: A PubMed search for all relevant publications regarding the R-RPLND series up until August 2019 was performed. The largest series were identified, and weighted means calculated for outcomes using the number of patients included in each study as the weighting factor. RESULTS: Fifty-six articles of R-RPLND were identified and eight series with more than 10 patients in each were included. The weighted mean age was 31.12 years; primary and post chemotherapy R-RPLND were performed in 50.59% and 49.41% of patients. The clinical stage was I, II and III in 47.20%, 39.57% and 13.23% of patients. A modified R-RPLND template was used in 78.02% of patients, while 21.98% underwent bilateral full template. The weighted mean node yield, operative time and estimated blood loss were, respectively, 22.15 nodes, 277.35 min and 131.94 mL. The weighted mean length of hospital stay was 2 days and antegrade ejaculation was preserved in 92.12% of patients. Major post-operative complications (Clavien III or IV) occurred in 5.34%. Positive pathological nodes were detected in 24.54%, while the recurrence free survival was 95.77% with a follow-up of 21.81 months. CONCLUSION: R-RPLND has proven to be a reproducible and safe approach in experienced centers; short-term oncologic outcomes are similar to the open approach with less morbidity and shorter convalescence related to its minimal invasiveness. However, longer follow-up and new trials comparing head-to-head both techniques are expected.

Extended Versus Limited Pelvic Lymph Node Dissection During Radical Prostatectomy for Intermediate- and High-risk Prostate Cancer: Early Oncological Outcomes from a Randomized Phase 3 Trial.

BACKGROUND: The role of extended pelvic lymph node dissection (EPLND) in the surgical management of prostate cancer (PCa) patients remains controversial, mainly because of a lack of randomized controlled trials (RCTs). OBJECTIVE: To determine whether EPLND has better oncological outcomes than limited PLND (LPLND. DESIGN, SETTING AND PARTICIPANTS: This was a prospective, single-center phase 3 trial in patients with intermediate- or high-risk clinically localized PCa. INTERVENTION: Randomization (1:1) to LPLND (obturator nodes) or EPLND (obturator, external iliac, internal iliac, common iliac, and presacral nodes) bilaterally. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was biochemical recurrence-free survival (BRFS). Secondary outcomes were metastasis-free survival (MFS), cancer-specific survival (CSS), and histopathological findings. The trial was designed to show a minimal 15% advantage in 5-yr BRFS by EPLND. RESULTS AND LIMITATIONS: In total, 300 patients were randomized from May 2012 to December 2016 (150 LPLND and 150 EPLND). The median BRFS was 61.4 mo in the LPLND group and not reached in the EPLND group (hazard ratio [HR] 0.91, 95% confidence interval [CI] 0.63-1.32; p = 0.6). Median MFS was not reached in either group (HR 0.57, 95% CI 0.17-1.8; p = 0.3). CSS data were not available because no patient died from PCa before the cutoff date. In exploratory subgroup analysis, patients with preoperative biopsy International Society of Urological Pathology (ISUP) grade groups 3-5 who were allocated to EPLND had better BRFS (HR 0.33, 95% CI 0.14-0.74, interaction p = 0.007). The short follow-up and surgeon heterogeneity are limitations to this study. CONCLUSION: This RCT confirms that EPLND provides better pathological staging, while differences in early oncological outcomes were not demonstrated. Our subgroup analysis suggests a potential BCRFS benefit in patients diagnosed with ISUP grade groups 3-5; however, these findings should be considered hypothesis-generating and further RCTs with larger cohorts and longer follow up are necessary to better define the role of EPLND during RP. PATIENT SUMMARY: In this study, we investigated early outcomes in prostate cancer patients undergoing prostatectomy according to the anatomic extent of lymph node resection. We found that extended removal of lymph nodes did not reduce biochemical recurrence of prostate cancer in the expected range.

Early Effects of High-intensity Focused Ultrasound (HIFU) Treatment for Prostate Cancer on Fecal Continence and Anorectal Physiology.

OBJECTIVE: To evaluate high-intensity focused ultrasound (HIFU) effects on anorectal physiology and fecal continence or constipation, and on quality of life (QoL). METHODS: We prospectively evaluated 26 patients with localized prostate cancer who underwent HIFU. The Rome III criteria for functional constipation, the Cleveland Clinic Florida Fecal Incontinence Score, and the Fecal Incontinence QoL Score questionnaires were answered before and after treatment. Anorectal manometry was used to evaluate resting and squeezing pressures, sustained contraction, paradoxical puborectalis contraction, rectal sensation, and rectal capacity. RESULTS: Thirteen patients underwent hemiablation and 13 underwent whole-gland ablation. There was no difference between groups regarding the Rome III criteria for functional constipation results. The Cleveland Clinic Florida Fecal Incontinence Score results showed that 3 (11.5%) of patients had mild fecal incontinence before HIFU and 5 (19.2%) had it afterward (P = .625). No patients reported poor QoL due to fecal incontinence in the Fecal Incontinence QoL Score. Anorectal manometry demonstrated no decrease in resting pressure after treatment (P = .299), while squeezing pressure significantly increased from 151.87 to 167.91 mm Hg (P = .034). The number of patients with normal sustained contraction remained the same (20 [77%]). Paradoxical puborectalis contraction was seen in 12 (46%) of the patients before the procedure and in 13 (50%) after (P = .713). Improvement in sensory parameters was not significant: first sense changed from 73.46 to 49.71 mL (P = .542) and first urge from 98.27 to 82.88 mL (P = .106). Rectal capacity had a nonsignificant decrease from 166.15 to 141.15mL (P = .073). CONCLUSION: HIFU did not cause significant changes in anorectal physiology. Fecal incontinence or constipation after HIFU was not observed via validated questionnaires.

Bilateral nephrectomy robotic-assisted laparoscopic in children with bilateral Wilms' tumor.

Our main objective is to report the feasibility of performing simultaneous robotic-assisted laparoscopic (RAL) right partial nephrectomy with contralateral radical nephrectomy in children with bilateral Wilms' tumor. The RAL right partial nephrectomy and contralateral radical nephrectomy were performed via trans-peritoneal with a four-port approach (five ports in one patient), and the patients were repositioned and draped when moving to the other side. The operative time was 90 min, estimated blood loss was 50 cc. Postoperative length of stay was 2 days. No significant intraoperative or postoperative complications occurred.

Robotic-assisted radical cystectomy: the first multicentric Brazilian experience.

The objective of this study is to report the first multicentric Brazilian series and learning curve of robotic radical cystectomy (RARC) with related intra- and postoperative outcomes. We retrospectively analyzed 37 RARC prospectively collected at four different centers in Brazil, from 2013 to 2019. We analyzed the patient's demographics, pathological tumor, and nodal status, as well as intra- and postoperative outcomes. Statistical analysis was performed with the IBM (SPSS version 25) software. Overall, 86% were male, and the median age was 69 years. 83% had muscle-invasive bladder cancer, and 17% a high-grade, recurrent non-muscle-invasive tumor. The median operative time was 420 min with 300 min as console time. Median blood loss was 350 ml and transfusion rate was 10%. In 68% of the cases, we performed an intracorporeal Bricker urinary diversion, 24% intracorporeal neobladder, and 8% ureterostomy. Six patients (16%) had a Clavien 1-2, 8% had Clavien 3, 2.5% had a Clavien 4, and 5% had Clavien 5. The median length of hospital stay was 7 days. The final pathological exam pointed out pT0 in 16%, pT1 in 8%, pT2 in 32%, ≥ pT3 in 27%, and 16% pTis. 95% had negative surgical margins. The survival at 30, 90, and 180 days was 98%, 95%, and 95%, respectively. To our knowledge, this is the first multicentric series of RARC reporting the learning curve in Brazil; even if still representing a challenging procedure, RARC could be safely and effectively faced by experienced surgeons at centers with high volumes of robotic surgery.