BACKGROUND AND OBJECTIVE:Trimodality therapy (TMT) is an accepted bladder-preserving option for selected patients with muscle-invasive bladder cancer (MIBC). Pembrolizumab has demonstrated activity in MIBC and may enhance the effects of chemotherapy and radiation. We evaluated the safety and efficacy of adding pembrolizumab to TMT. METHODS:In this multicenter phase 2 trial, patients with MIBC received one dose of pembrolizumab followed by maximal transurethral resection, then definitive bladder radiation with concurrent low-dose gemcitabine and pembrolizumab every 3 wk for three doses. The primary end point was 2-yr bladder-intact disease-free survival (BIDFS). Secondary end points included safety, metastasis-free survival (MFS), and overall survival (OS). KEY FINDINGS AND LIMITATIONS:Fifty-four patients were enrolled, including 48 in the efficacy cohort; 67% had clinical stage T2 disease. The 2-yr BIDFS was 60% (95% confidence interval [CI], 45-73). Two-yr MFS and OS were 81% (95% CI, 66-92) and 83% (95% CI, 69-91), respectively. Grade ≥3 treatment-related adverse events occurred in 25% of patients. Limitations include the single-arm design and modest sample size. CONCLUSIONS AND CLINICAL IMPLICATIONS:Pembrolizumab combined with gemcitabine-based chemoradiation was feasible and showed efficacy comparable to standard TMT. Ongoing phase 3 trials will further define its role in bladder preservation.

Introduction Prostate cancer (PCa) extraprostatic extension (EPE) is common, occurring in ∼30% of men undergoing radical prostatectomy; positive surgical margins (PSM) during radical prostatectomy are frequent as well, occurring in up to 50% of cases with EPE. Stimulated Raman histology (SRH) is a novel microscopic technique allowing real time, label-free, high-resolution microscopic images of unprocessed, un-sectioned tissue providing both morphologic and biochemical information of imaged tissue. We hypothesized that artificial intelligence (AI) utilizing prostate biopsy SRH from MRI identified PCa and clinical variables can predict both EPE and PSM. Methods Prospectively, targeted prostate biopsies from ex-vivo radical prostatectomy specimens, 99% obtained from MRI visible PCa. Prostate biopsies were scanned in a SRH microscope using two Raman shifts: 2845cm-1 and 2930cm-1, to create SRH images. Ex-vivo prostate biopsies were taken from 108 radical prostatectomy specimens to train an attention-based multiple instance learning deep learning neural network (DLNN) made interpretations based on the highest risk patch(s) and/or clinical characteristics as described in Table 1. The DLNN was tested on prostate biopsies from 33 consecutive radical prostatectomy specimens MRI identified PCa (Table 1) yielding receiver operating curve area under the curve (AUC) characteristics. Clinical variables utilized for creation and testing of the DLNN were age, PSA, PSA density, PI-RADS score, region of interest largest dimension and region of interest area. Results The combination of clinical variables and SRH image resulted in an AUC for prediction of PSM of 0.875. Utilizing clinical variables alone, the DLNN predicted PSM with an AUC of 0.787, while assessment of the SRH alone showed an AUC of 0.741.Prediction based on SRH alone, the DLNN predicted EPE with an AUC of 0.795; while analyzing clinical variables alone showed an AUC of 0.59. The addition of clinical variables the SRH DLNN did not further increase the AUC above that of SRH image assessment alone. Conclusions The prediction of EPE alone was best with AI and SRH alone, indicating the clinical factors were not necessary for prediction of EPE. However, the prediction of PSM was best with both clinical and SRH, indicating clinical variables may be required to accurately predict cases where surgeons are likely to perform an incomplete resection. Further validation of these results is required in larger multicentre studies.

Background In-field or in-margin recurrence after partial gland cryosurgical ablation (PGCA) of prostate cancer (PCa) remains a limitation of the paradigm. Stimulated Raman histology (SRH) is a novel microscopic technique allowing real time, label-free, high-resolution microscopic images of unprocessed, un-sectioned tissue which can be interpreted by humans or artificial intelligence (AI). We evaluated surgical team and AI interpretation of SRH for real-time pathologic feedback in the planning and treatment of PCa with PGCA. Methods About 12 participants underwent prostate mapping biopsies during PGCA of their PCa between January and June 2022. Prostate biopsies were immediately scanned in a SRH microscope at 20 microns depth using 2 Raman shifts to create SRH images which were interpreted by the surgical team intraoperatively to guide PGCA, and retrospectively assessed by AI. The cores were then processed, hematoxylin and eosin stained as per normal pathologic protocols and used for ground truth pathologic assessment. Results Surgical team interpretation of SRH intraoperatively revealed 98.1% accuracy, 100% sensitivity, 97.3% specificity for identification of PCa, while AI showed a 97.9% accuracy, 100% sensitivity and 97.5% specificity for identification of clinically significant PCa. 3 participants’ PGCA treatments were modified after SRH visualized PCa adjacent to an expected MRI predicted tumor margin or at an untreated cryosurgical margin. Conclusion SRH allows for accurate rapid identification of PCa in PB by a surgical team interpretation or AI. PCa tumor mapping and margin assessment during PGCA appears to be feasible and accurate. Further studies evaluating impact on clinical outcomes are warranted.

You have accessJournal of UrologyPenile & Testicular Cancer II (MP61)1 May 2024MP61-07 SINGLE-PORT ROBOTIC ASSISTED INGUINAL LYMPH NODE DISSECTION (ILND): A SINGLE INSTITUTION EXPERIENCE Jesse Persily, Sameer Thakker, Shavy Nagpal, Anthony Corcoran, Katie Murray, James Wysock, Lee Zhao, and William Huang Jesse PersilyJesse Persily , Sameer ThakkerSameer Thakker , Shavy NagpalShavy Nagpal , Anthony CorcoranAnthony Corcoran , Katie MurrayKatie Murray , James WysockJames Wysock , Lee ZhaoLee Zhao , and William HuangWilliam Huang View All Author Informationhttps://doi.org/10.1097/01.JU.0001009536.58867.87.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Open ILND for penile cancer has been plagued by a high complication rate. Minimally invasive ILND has evolved from pure laparoscopic to multi-port (MP) robotic, to single port (SP) robotic, with the goal of decreasing morbidity without impacting oncologic outcomes. SP ILND has only been reported in case series. We present our single institution experience of both MP and SP robotic ILND. METHODS: We reviewed our retrospective, IRB approved database of robotic ILND performed at our institution since 2015, for a total of 30 groin dissections. In most cases, ICG is injected at the base of the penis, and the near-infrared setting is used to ensure complete removal of nodal tissue (Figure 1A). Representative groins after MP ILND (Figure 1B) and SP (Figure 1C) are shown. We assessed demographic and pre-operative characteristics of the individual patients and analyzed operative outcomes of each groin separately, comparing MP to SP. RESULTS: 20 patients have undergone robotic ILND at our institution, for a total of 30 groin dissections (Table 1). Median follow up from first ILND was 12 months (IQR 3-40.5 months). 7 of these ILNDs were performed with the SP. MP vs. SP ILND was compared in Table 2. Median length of stay was 1 day. There was only one intraoperative complication, and operative time and EBL were similar between MP and SP. 5 patients required IR drainage of fluid collections. There were no major wound complications. Lymph node yield was slightly higher after SP, but similar between groups. CONCLUSIONS: SP ILND appears to be a safe and effective approach to ILND for penile cancer. Adoption of a minimally invasive approach has allowed us to perform a complete groin dissection while reducing morbidity. Further research is needed to determine whether the transition from MP to SP improves patient morbidity. Download PPT Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1012 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Jesse Persily More articles by this author Sameer Thakker More articles by this author Shavy Nagpal More articles by this author Anthony Corcoran More articles by this author Katie Murray More articles by this author James Wysock More articles by this author Lee Zhao More articles by this author William Huang More articles by this author Expand All Advertisement PDF downloadLoading ...

We thank the authors for their review of and comment on our manuscript and we fundamentally agree that these results support the ongoing inclusion of systematic biopsy with targeted biopsy.

INTRODUCTION:Local disease recurrence following focal therapy (FT) for prostate cancer may be due to failure to eradicate focal disease or development of disease in the untreated prostate (in- and out-of-field recurrences). Several studies suggest in-field contrast enhancement (CE) on post-treatment multi-parametric (mp) MRI between 6-12 months following FT indicates residual disease. The present study assesses the incidence and oncologic implications of early CE observed following primary partial gland cryoablation (PPGCA). MATERIAL AND METHODS:The surveillance protocol for men enrolled in our prospective outcomes study following PPGCA included mpMRI at 6-12 months, 2 years, 3.5 years, and 5 years. All cases of in-field early CE were re-reviewed retrospectively and graded using the previously described Prostate Imaging after Focal Ablation scoring system. All patients exhibiting early CE were re-evaluated by a single radiologist at 2-year mpMRI Results: A total of 320 men enrolled in our PPGCA outcomes study had at least 6 months of follow up. Three hundred fifteen (98%) of these men had undergone post-PPGCA mpMRI at 6-12 months. Of these men, 9 were found to have early in-field CE and 8 underwent repeat MRI at 2 years. In all 8 cases, the CE resolved on the 2-year mpMRI. Of these 8 patients, seven underwent repeat protocol biopsy at 2 years and in-field significant disease was detected in only 1 case. CONCLUSIONS:The most compelling evidence that early CE is not indicative of prostate cancer recurrence is that all lesions resolved within 24 months. While incidence of early CE is low, its consistent resolution calls into question the clinical significance of this finding after PPGCA.

The treatment options for prostate cancer typically entail active surveillance, surgery, radiation, or a combination of the above. Disease recurrence remains a concern, with a wide range of recurrence rates having been reported in the literature. In the setting of recurrence, the salvage treatment options include salvage prostatectomy, salvage high-intensity focused ultrasound (HIFU), stereotactic body radiotherapy (SBRT), salvage brachytherapy, and salvage cryoablation. In this review, we analyze the currently available data related to salvage cryoablation for recurrent prostate cancer following radiation.