Utility of 18F-Fluciclovine PET/MRI for Staging Newly Diagnosed High-Risk Prostate Cancer and Evaluating Response to Initial Androgen Deprivation Therapy: A Prospective Single-Arm Pilot Study.

BACKGROUND. Despite advances in prostate cancer treatment, rates of biochemical recurrence remain high, relating to lack of detection of small-volume metastatic disease using conventional imaging for initial staging. OBJECTIVE. The purpose of this study was to assess the potential use of 18F-fluciclovine PET/MRI for initial staging of high-risk prostate cancer and evaluating response to androgen deprivation therapy (ADT). METHODS. This prospective clinical trial enrolled 14 men with newly diagnosed high-risk prostate cancer and negative or equivocal conventional staging imaging for metastatic disease between January 2018 and February 2019. All patients underwent pretreatment 18F-fluciclovine PET/MRI including multiparametric prostate MRI; 12 underwent 18F-fluciclovine PET/MRI after surgery or between ADT and radiotherapy. Confidence in identification of the primary intraprostatic lesion and nodal metastases was independently rated on a 0-3 Likert scale by three readers with nuclear medicine experience for 18F-fluciclovine PET/MRI and three readers with abdominal imaging experience for MRI alone. Findings scored as 2 or 3 by at least two readers of a given modality were considered positive. A single reader measured SUVmean, SUVmax, and volume of the MRI-defined intraprostatic lesion and SUVmax of suspicious lymph nodes on PET before and after initiation of ADT. Changes in SUV were analyzed using nonparametric Wilcox-on signed-rank tests. RESULTS. The biopsy-proven lesion in the prostate gland was accurately identified in all 14 patients on both MRI and 18F-fluciclovine PET/MRI. Suspected nodal metastases were detected in three patients on MRI and seven patients on 18F-fluciclovine PET/MRI. After ADT, all patients showed decreased activity within the intraprostatic lesion and/or all suspicious lymph nodes. The primary lesion SUVmean was 4.5 ± 1.1 (range, 2.7-6.5) before treatment and 2.4 ± 1.1 (range, 0.0-3.6) after initiation of ADT (p = .008). For suspicious lymph nodes, the pretreatment SUVmax was 5.5 ± 3.7 (range, 2.8-12.7) and the post-treatment SUVmax was 2.8 ± 1.4 (range, 1.4-5.5) (p = .03). CONCLUSION.18F-labeled fluciclovine PET/MRI shows potential utility in initial staging of high-risk prostate cancer and in evaluating response to ADT. CLINICAL IMPACT. Given the FDA approval and widespread availability of 18F-fluciclovine, the findings could have an impact in the immediate future in guiding initial management of patients with prostate cancer. TRIAL REGISTRATION. ClinicalTrials.gov NCT03264456.

Stereotactic body radiation therapy with simultaneous integrated boost for prostate cancer: does MRI-targeted biopsy alter the boost field?

INTRODUCTION: We aim to investigate if the addition of MRI-US fusion biopsy (FB) can aid in radiation planning and alter the boost field in cases of stereotactic body radiation therapy (SBRT) for prostate cancer with a simultaneous integrated boost (SIB) to a magnetic resonance imaging (MRI)-defined intraprostatic lesion. MATERIALS AND METHODS: Patients undergoing SBRT with SIB for biopsy-proven prostatic adenocarcinoma and a pre-radiation MRI were retrospectively reviewed. 36.25 Gy in 5 fractions was delivered to entire prostate along with SIB of 40 Gy to an MRI-defined intraprostatic lesion. Demographic, radiation planning details, and post-procedural outcomes were compared between patients undergoing systematic transrectal ultrasound (TRUS) biopsy followed by MRI to those undergoing an MRI followed by a FB prior to radiation planning. RESULTS: Forty-three patients underwent systematic TRUS biopsy followed by MRI and 46 patients underwent FB prior to radiation planning. Patients undergoing systematic TRUS biopsy had a smaller prostate volume when compared to the FB cohort (37.58 ± 13.78 versus 50.28 ± 26.76 cc, p = 0.007). No differences in prostate planning target volume (PTVprostate) and boost volume (PTVboost) were noted, but those undergoing TRUS biopsy prior to MRI had a higher integrated boost volume density (IBVD = PTVboost/total prostate volume) (0.16 ± 0.09 versus 0.13 ± 0.06, p = 0.045). No differences were observed in genitourinary or gastrointestinal toxicity rates. CONCLUSIONS: Compared to systematic TRUS biopsy, implementation of prebiopsy prostate MRI and FB allows for safe and feasible SBRT in patients with significantly larger prostate volumes without increasing SIB cancer-directed treatment volumes, oncologic outcomes, quality of life measures, or treatment-related toxicities.

Perioperative Outcomes of Single vs Multi-Port Robotic Assisted Radical Prostatectomy: A Single Institutional Experience.

PURPOSE: Surgical approach to radical prostatectomy has evolved due to advances in minimally invasive surgery, with most contemporary approaches involving the Si or Xi multi-port robotic systems. U.S. Food and Drug Administration approval of the single-port da Vinci® SP robotic platform has led to a few case series suggesting its safety and feasibility for robotic assisted radical prostatectomy in patients with prostate cancer. However, there are no established data on perioperative outcomes comparing single-port to multi-port robotic approaches to robot-assisted radical prostatectomy. MATERIALS AND METHODS: All patients who underwent robot-assisted radical prostatectomy by 2 urological surgeons at our institution between October 2018 and June 2019 were retrospectively reviewed. The available preoperative clinical and demographic data, operative parameters and postoperative outcomes were collected and analyzed using the t-test, chi-square and Fisher exact statistical measures. RESULTS: Overall 95 patients who underwent robot-assisted radical prostatectomy at our institution were included in our study, with 47 single-port and 48 multi-port. Preoperative clinical parameters including age, body mass index, prior abdominal surgery and biopsy grade group were similar across the 2 groups. No differences in estimated blood loss (169.2±114.2 vs 157.7±125.4 ml, p=0.64), operative time (255.9±44.1 vs 274.7±50.4 minutes, p=0.06), length of hospitalization (1.1±0.5 vs 1.4±1.1 days, p=0.17), rate of perioperative inpatient Clavien-Dindo complications 2 or greater (4.3% vs 6.3% p=0.66) and rate of positive pathological margin (21.3% vs 27.1%, p=0.51) were noted comparing the single-port and multi-port approaches, respectively. CONCLUSIONS: The single-port robotic system allows a feasible approach to robot-assisted radical prostatectomy and has operative and perioperative outcomes comparable to those of the well accepted multi-port robotic approach.

Multi-institutional nomogram predicting benign prostate pathology on magnetic resonance/ultrasound fusion biopsy in men with a prior negative 12-core systematic biopsy.

BACKGROUND: Prostate multiparametric magnetic resonance imaging (mpMRI) may be recommended for patients with a prior negative systematic biopsy (SB). However, a proportion of these patients will continue to have no prostate cancer (PCa) identified on magnetic resonance/ultrasound fusion biopsy (FB) despite abnormal mpMRI findings. METHODS: In this multi-institutional, retrospective study, clinical and mpMRI parameters were assessed for 285 consecutive patients with at least 1 prior negative biopsy who underwent FB for a Prostate Imaging Reporting and Data System (PI-RADS) score of 3 to 5 at the University of Rochester Medical Center from December 2014 to December 2016, or at the University of Alabama at Birmingham from February 2014 to February 2017. Nomograms were generated for predicting benign prostate pathology on both the targeted biopsy and the concurrent SB. RESULTS: Benign pathology was found in 132 of 285 patients (46.3%). In a multivariate analysis, the predictors of benign prostate pathology on FB were age, prostate-specific antigen, prostate volume, and PI-RADS score. The predicted probabilities were plotted on a receiver operating characteristic curve, and the area under the curve was 0.825. The nomogram demonstrated excellent calibration and a high net benefit in a decision curve analysis. With a theoretical cutoff probability of ≥0.7 used to recommend deferment of FB, 61 of 285 patients (21.4%) would have avoided an unnecessary biopsy, and only 4 of 285 patients (1.4%) with PCa with a Gleason score ≥ 3 + 4 would have been missed. CONCLUSIONS: False-positive mpMRI examinations may occur in up to 46.3% of patients with a prior negative biopsy. Thus, a multi-institutional nomogram has been developed and validated for predicting benign pathology after FB in patients with a prior negative biopsy, and this may help to reduce the number of unnecessary biopsies in the setting of abnormal mpMRI findings. Cancer 2018;124:278-85. © 2017 American Cancer Society.

Factors predicting prostate cancer upgrading on magnetic resonance imaging-targeted biopsy in an active surveillance population.

BACKGROUND: The objective of this study was to create a nomogram model integrating clinical and multiparametric magnetic resonance imaging (MP-MRI)-based variables to predict prostate cancer upgrading in a population of active surveillance (AS) patients. METHODS: Prostate cancer patients on AS who underwent MP-MRI with magnetic resonance imaging (MRI)/ultrasound (US) fusion-guided biopsy were identified. Clinical and imaging variables, including the prostate-specific antigen density (PSAD), number of lesions, total lesion volume, total lesion density, Prostate Imaging Reporting and Data System magnetic resonance imaging suspicion score (MRI-SS), and duration between prereferral systematic and MRI/US fusion-guided biopsy sessions, were assessed. Logistic regression modeling was used to assess upgrading on MRI/US fusion-guided biopsy. A predictive model for upgrading was calculated with the significant factors identified. RESULTS: Seventy-six patients were analyzed with a mean age of 62.5 years and a median prostate-specific antigen (PSA) level of 5.1 ng/mL. The average duration between prereferral and MRI/US biopsies was 21 months. Twenty patients (26.32%) were upgraded. The PSAD, duration between prereferral and MRI/US biopsies, MRI-SS, and MRI total lesion density were significantly associated with upgrading. A logistic regression model using these factors to predict upgrading on confirmatory MRI/US fusion biopsy had an area under the curve (AUC) of 0.84, whereas the AUC was 0.69 with PSA alone. On the basis of this model, a nomogram was generated, and using a probability cutoff of 22% as an indication of upgrading, it produced sensitivity, specificity, positive predictive, and negative predictive values of 80%, 81.25%, 57.1%, and 92.86%, respectively. CONCLUSIONS: The integration of MRI findings with clinical parameters can add value to a model predicting upgrading from a Gleason score of 3 + 3 = 6 in men on AS. This can potentially be used as a noninvasive approach to confirm AS patients with low-risk disease for whom biopsy may be deferred. Cancer 2017;123:1941-1948. © 2017 American Cancer Society.

Diagnostic value of biparametric magnetic resonance imaging (MRI) as an adjunct to prostate-specific antigen (PSA)-based detection of prostate cancer in men without prior biopsies.

OBJECTIVES: To determine the diagnostic yield of analysing biparametric (T2- and diffusion-weighted) magnetic resonance imaging (B-MRI) for prostate cancer detection compared with standard digital rectal examination (DRE) and prostate-specific antigen (PSA)-based screening. PATIENTS AND METHODS: Review of patients who were enrolled in a trial to undergo multiparametric-prostate (MP)-MRI and MR/ultrasound fusion-guided prostate biopsy at our institution identified 143 men who underwent MP-MRI in addition to standard DRE and PSA-based prostate cancer screening before any prostate biopsy. Patient demographics, DRE staging, PSA level, PSA density (PSAD), and B-MRI findings were assessed for association with prostate cancer detection on biopsy. RESULTS: Men with detected prostate cancer tended to be older, with a higher PSA level, higher PSAD, and more screen-positive lesions (SPL) on B-MRI. B-MRI performed well for the detection of prostate cancer with an area under the curve (AUC) of 0.80 (compared with 0.66 and 0.74 for PSA level and PSAD, respectively). We derived combined PSA and MRI-based formulas for detection of prostate cancer with optimised thresholds. (i) for PSA and B-MRI: PSA level + 6 x (the number of SPL) > 14 and (ii) for PSAD and B-MRI: 14 × (PSAD) + (the number of SPL) >4.25. AUC for equations 1 and 2 were 0.83 and 0.87 and overall accuracy of prostate cancer detection was 79% in both models. CONCLUSIONS: The number of lesions positive on B-MRI outperforms PSA alone in detection of prostate cancer. Furthermore, this imaging criteria coupled as an adjunct with PSA level and PSAD, provides even more accuracy in detecting clinically significant prostate cancer.

Multiparametric magnetic resonance imaging (MRI) and subsequent MRI/ultrasonography fusion-guided biopsy increase the detection of anteriorly located prostate cancers.

OBJECTIVE: To describe the detection rate of anteriorly located prostate cancer (PCa) with the addition of magnetic resonance imaging (MRI)/ultrasonography (US) fusion-guided biopsy (FGB) to the standard transrectal ultrasonography (TRUS)-guided biopsy. PATIENTS AND METHODS: All patients, regardless of their biopsy history, who were referred for clinical suspicion of PCa (i.e elevated prostate-specific antigen (PSA) level and abnormal digital rectal examination) underwent 3T multiparametric-MRI (mpMRI) screening; and those with suspicious lesions in the anterior region of the prostate were identified. Patients then received a FGB of all suspicious lesions in addition to a systematic 12-core extended sextant TRUS-guided biopsy. We conducted a lesion-based analysis comparing cancer detection rates of anterior targets using FGB vs systematic cores taken from the same anatomic sextant within the prostate. Lengths of cancer in the most involved core were also compared between the two biopsy techniques used. Patients with only anterior targets were analysed separately. RESULTS: Of 499 patients undergoing FGB, 162 had a total of 241 anterior lesions. The mean age, PSA level and prostate volume in this group were 62 years, 12.7 ng/dL, and 57 mL, respectively. In total, PCa was diagnosed in 121 anterior lesions (50.2%) identified on mpMRI. Sixty-two (25.7%) of these anterior lesions were documented as positive for cancer on systematic 12-core TRUS-guided biopsy cores, while 97 (40.2%) were positive on the targeted FGB cores (P = 0.001). In lesions that were positive on both FGB and TRUS biopsy, the most involved core was 112% longer on FGB (3.7 vs 1.6 mm, P ≤ 0.01). Forty-two patients had only anterior lesions on mpMRI; of these, 24 (57.1%) were found to have cancer on the FGB + TRUS biopsy platform. Six patients were positive on FGB only and 13 were positive on both biopsy techniques; however, 7/13 patients were upgraded to a higher Gleason score after FGB. All five patients positive on TRUS biopsy only were candidates for active surveillance. CONCLUSION: The results showed that FGB detects significantly more anteriorly located PCa than does TRUS-guided biopsy alone and it may serve as an effective tool for the subset of patients with such tumours.

Postoperative Outcomes and Analgesic Requirements of Single-Port vs Multiport Robotic-Assisted Radical Cystectomy.

Objective: To compare outcomes in patients undergoing robotic-assisted radical cystectomy (RARC) with urinary diversion for bladder cancer with either the single-port (SP) or multiport (MP) robotic platform. Methods: All patients who underwent SP and MP RARC at our institution between January 2018 and January 2023 were retrospectively reviewed. Postoperative analgesia was administered by a departmentwide narcotic stewardship protocol, and inpatient and outpatient narcotic use was tracked. The available preoperative clinical, operative, and postoperative outcomes were analyzed using t-test, chi-square, and Fischer exact statistical measures. Kaplan-Meier analysis with log-rank testing was used to determine the freedom from high-grade (Clavien-Dindo grade ≥3) postoperative complications stratified by SP or MP robotic use. Results: Overall, 96 patients underwent RARC with urinary diversion at our institution, with 49 MP and 47 SP procedures performed. Preoperative clinical parameters including age, body mass index, prior abdominal surgery, and use of neoadjuvant chemotherapy were similar between the two groups. Patients undergoing SP RARC had a shorter operative time (386.0 ± 90.9 minutes vs 453.6 ± 94.8 minutes, p < 0.01) and faster return of bowel function (3.4 ± 1.4 days vs 4.5 ± 2.2 days, p < 0.01). However, both cohorts had similar length of hospitalization, postoperative narcotic use, pathologic staging, and rate of positive surgical margin. Within 3 months postoperatively, both cohorts had a similar high-grade complication, hospital readmission, and cancer recurrence rate. Conclusions: The SP robot allows a safe alternative surgical approach for RARC and offers similar postoperative outcomes compared to the MP robot.

Accuracy of multiparametric magnetic resonance imaging in confirming eligibility for active surveillance for men with prostate cancer.

BACKGROUND: Active surveillance (AS) is an attempt to avoid overtreatment of clinically insignificant prostate cancer (PCa); however, patient selection remains controversial. Multiparametric prostate magnetic resonance imaging (MP-MRI) may help better select AS candidates. METHODS: We reviewed a cohort of men who underwent MP-MRI with MRI/Ultrasound fusion-guided prostate biopsy and selected potential AS patients at entry using Johns Hopkins criteria. MP-MRI findings were assessed, including number of lesions, dominant lesion diameter, total lesion volume, prostate volume, and lesion density (calculated as total lesion volume/prostate volume). Lesions were assigned a suspicion score for cancer by MRI. AS criteria were reapplied based on the confirmatory biopsy, and accuracy of MP-MRI in predicting AS candidacy was assessed. Logistic regression modeling and chi-square statistics were used to assess associations between MP-MRI interpretation and biopsy results. RESULTS: Eighty-five patients qualified for AS with a mean age of 60.2 years and mean prostate-specific antigen level of 4.8 ng/mL. Of these, 25 patients (29%) were reclassified as not meeting AS criteria based on confirmatory biopsy. Number of lesions, lesion density, and highest MRI lesion suspicion were significantly associated with confirmatory biopsy AS reclassification. These MRI-based factors were combined to create a nomogram that generates a probability for confirmed AS candidacy. CONCLUSION: As clinicians counsel patients with PCa, MP-MRI may contribute to the decision-making process when considering AS. Three MRI-based factors (number of lesions, lesion suspicion, and lesion density) were associated with confirmatory biopsy outcome and reclassification. A nomogram using these factors has promising predictive accuracy for which future validation is necessary. Cancer 2013;119:3359-66. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

Are markers of survival associated with perioperative outcomes for tumor thrombectomy patients?

INTRODUCTION: Despite modern advances in surgical and perioperative technologies, management of renal cell carcinoma (RCC) with tumor thrombus (TT) is a morbid procedure that necessitates careful patient selection. It is not known whether established prognostic models for metastatic RCC are suitable prognostic tools for more immediate perioperative outcomes in patients with RCC with TT. We evaluated if established risk models for cytoreductive nephrectomy, as a potential extension of their purpose-built use, are associated with immediate perioperative outcomes in patients undergoing nephrectomy and tumor thrombectomy. METHODS: Perioperative outcomes of patients who underwent radical nephrectomy and tumor thrombectomy for RCC were compared to presences of established predictors of long-term outcomes from prior risk models individually and as stratified by risk grouping (International Metastatic Renal-Cell Carcinoma Database Consortium [IMDC], Memorial Sloan Kettering Cancer Center [MSKCC], M.D. Anderson Cancer Center [MDACC], and Moffitt Cancer Center [MCC]). Wilcoxon rank-sum test or the Kruskal-Wallis test compared continuous variables and the chi-square test or Fisher's exact test compared categorical variables. RESULTS: Fifty-five patients were analyzed with 17 (30.9%) being cytoreductive. Eighteen (32.7%) patients had a level III or higher TT. Individually, preoperative variables were inconsistently associated with perioperative outcomes. Poorer risk patients per the IMDC model had more major postoperative complications (Clavien-Dindo grade≥3, P = 0.008). For the MSKCC model, poorer risk patients had increased intraoperative estimated blood loss (EBL), longer length of stay (LOS), more major postoperative complications, and more likely to discharge to a rehabilitation facility (P < 0.05). Less favorable risk patients per MDACC model had increased LOS (P = 0.038). Poorer risk patients per the MCC model had increased EBL, LOS, major postoperative complications, and 30-day hospital readmissions (P < 0.05). CONCLUSION: Overall, cytoreductive risks models were heterogeneously associated with perioperative outcomes in patients undergoing nephrectomy and tumor thrombectomy. Of available models, the MCC model is associated with more perioperative outcomes including EBL, LOS, major postoperative complications, and readmissions within 30 days when compared to the IMDC, MSKCC, and MDACC models.

Prostate Stereotactic Body Radiation Therapy With a Focal Simultaneous Integrated Boost: 5-Year Toxicity and Biochemical Recurrence Results From a Prospective Trial.

PURPOSE: Stereotactic body radiation therapy (SBRT) is increasingly used as a definitive treatment option for patients with prostate adenocarcinoma. The aim of this study was to assess the late toxicity, patient-reported quality of life outcomes, and biochemical recurrence rates after prostate SBRT with simultaneous integrated boost (SIB) targeting lesions defined by magnetic resonance imaging (MRI). METHODS AND MATERIALS: Patients were eligible if they had biopsy-proven low- or intermediate-risk prostate adenocarcinoma, one or more focal lesions on MRI, and an MRI-defined total prostate volume of <120 mL. All patients received SBRT delivered to the entire prostate to a dose of 36.25 Gy in 5 fractions with an SIB to the lesions seen on MRI to 40 Gy in 5 fractions. Late toxicity was defined as any possible treatment-related adverse event occurring after 3 months from the completion of SBRT. Patient-reported quality of life was ascertained using standardized patient surveys. RESULTS: A total of 26 patients were enrolled. Six patients (23.1%) had low-risk disease and 20 patients had intermediate-risk disease (76.9%). Seven patients (26.9%) received androgen deprivation therapy. Median follow-up was 59.5 months. No biochemical failures were observed. Three patients (11.5%) experienced late grade 2 genitourinary (GU) toxicity requiring cystoscopy, and 7 patients (26.9%) had late grade 2 GU toxicity requiring oral medications. Three patients (11.5%) had late grade 2 gastrointestinal toxicity characterized by hematochezia requiring colonoscopy and steroids per rectum. There were no grade 3 or higher toxicity events observed. The patient-reported quality-of-life metrics at the time of last follow-up were not significantly different than the pre-treatment baseline. CONCLUSIONS: The results of this study support that SBRT to the entire prostate to a dose of 36.25 Gy in 5 fractions with focal SIB to 40 Gy in 5 fractions has excellent biochemical control and is not associated with undue late gastrointestinal or GU toxicity or long-term quality of life decrement. Focal dose escalation with an SIB planning approach may be an opportunity to improve biochemical control while limiting dose to nearby organs at risk.

Very distal apical prostate tumours: identification on multiparametric MRI at 3 Tesla.

UNLABELLED: What's known on the subject? and What does the study add? MRI has been shown to improve prostate cancer detection rates. Pinto et al. (J Urol 2011; 86: 1281-5) reported their outcomes on 101 patients with low, moderate or high suspicion lesions on multiparametric MRI that were subsequently targeted via an MRI/ultrasound fusion biopsy platform. The prostate cancer detection rates were 27%, 66% and 89% respectively. Sciarra et al. (Clin Cancer Res 2010; 16: 1875-83) performed a prospective trial in 180 patients with prior negative biopsy and persistent PSA elevation. Patients were randomized to either MRI targeted biopsy followed by random 12-core TRUS biopsy vs random TRUS guided biopsy alone. Prostate cancer detection in the MRI targeted group was 45.5% vs 24.4% in the random group. Although MRI has been shown to improve prostate cancer detection rates, there has not previously been any work looking at the ability of MRI to detect prostate cancer localized to the very distal apex of the prostate. This is an important topic in that it might lead clinicians to counsel their patients in treatment decisions if it is felt that a treatment might not treat this section of the prostate well, e.g. high intensity focused ultrasound therapy that might spare the distal apex. OBJECTIVE: • To describe an undescribed 'very distal' apical prostate cancer on multiparametric MRI (mpMRI) since apical prostate cancer can be difficult to detect in transrectal ultrasound guided biopsy and might therefore be missed in treatment decisions such as high intensity focused ultrasound or surgical therapy. PATIENTS AND METHODS: • From January 2011 to December 2012 a total of 210 consecutive patients underwent 3 T mpMRI with endorectal coil followed by our previously described MRI/ultrasound image fused and directed TRUS biopsies. • Patients also underwent 12-core TRUS sextant biopsies. • The inclusion criteria required at least one distal apical prostate lesion visualized on mpMRI and targeted for biopsy. RESULTS: • A total of 38 men (median age 62 years, median PSA 7.68 ng/dL) were identified as having distal apical prostate cancer on mpMRI. • Thirteen patients (34%) had a prior diagnosis of cancer and were on active surveillance protocols while 25 (66%) did not. Of those patients, 21 (55%) had undergone a median of two prior negative biopsies. • Twenty-two patients (58%) were positive on biopsy for prostate cancer. On breakdown of patients who were positive, 17 (77%) were positive on TRUS random biopsies and 21 (95%) were positive on MRI targeted biopsies with the majority of patients having multifocal disease. • At the distal apical lesions of interest, 80% were positive on MRI targeted biopsy. In addition 33% of these patients were upgraded based on MRI targeted biopsy at the distal lesion. CONCLUSIONS: • Very distal apical prostate cancer can be accurately detected and sampled with mpMRI and subsequent MRI/ultrasound fusion biopsy. • This may aid clinicians and patients in decision making for therapeutic modalities.

Single- versus multi-port robotic partial nephrectomy: a comparative analysis of perioperative outcomes and analgesic requirements.

Evidence supporting the safe use of the single-port (SP) robot for partial nephrectomy is scarce. The purpose of this study was to compare perioperative outcomes for patients undergoing robotic assisted SP vs multi-port (MP) partial nephrectomy (PN) in a time-matched cohort. All patients with clinically localized renal masses who underwent robotic PN from January 2019 to March 2020 were evaluated. Patients were stratified according to SP vs MP approach. Postoperative analgesia was administered in accordance with department-wide opioid stewardship protocol and outpatient opioid use was tracked. Total of 78 patients underwent robotic PN with 26 patients in the SP cohort. The majority of renal masses had low-complexity (53, 67.9%) R.E.N.A.L. nephrometry scores, without a significant difference between the two cohorts (p = 0.19). A retroperitoneal approach was performed in 16 (20.5%) patients overall, though more commonly via the SP robotic approach (13 vs 3, p < 0.001). Mean operative time for SP cases was 183.9 ± 63.5 min vs 208.6 ± 65.0 min in the MP cohort (p = 0.12). Rate of conversion to radical nephrectomy was 3.8% vs 9.6% for SP vs MP cases, respectively, (p = 0.37). The majority of patients were discharged on postoperative day one (67.9%) irrespective of operative approach (p = 0.60). There were no differences in inpatient milligram morphine equivalents administered (MME, p = 0.08) or outpatient postoperative MME prescribed (p = 0.21) between the two cohorts. In this retrospective single-institution study, SP robotic approach offers similar short-term perioperative outcomes to MP platforms for minimally invasive, nephron-sparing surgery. Using the SP system was not associated with a reduction in postoperative opioid analgesic requirements.

Portable Perfusion Phantom Offers Quantitative Dynamic Contrast-Enhanced Magnetic Resonance Imaging for Accurate Prostate Cancer Grade Stratification: A Pilot Study.

RATIONALE AND OBJECTIVES: The study goal was to test whether the improved accuracy in quantitative dynamic contrast-enhanced magnetic resonance imaging measurement using a point-of-care portable perfusion phantom (P4) leads to better stratification of prostate cancer grade. MATERIALS AND METHODS: A prospective clinical study was conducted recruiting 44 patients scheduled for multi-parameter MRI prostate exams. All participants were imaged with the P4 placed under their pelvic regions. Tissue sampling was carried out for 25 patients at 22 ± 18 (mean ± SD) days after multi-parameter MRI. On histologic examination, a total of 31 lesions were confirmed as prostate cancer. Tumors were classified into low grade (n = 14), intermediate grade (n = 10), and high grade (n = 7). Tumor perfusion was assessed by volume transfer constant, Ktrans, before and after P4-based error correction, and the Ktrans of low, intermediate and high-grade tumors were statistically compared. RESULTS: After P4-based error correction, the Ktrans of low, intermediate, and high-grade tumors were 0.109 ± 0.026 min-1 (95% CI: 0.0094 to 0.124 min-1), 0.163 ± 0.049 min-1 (95% CI: 0.129 to 0.198 min-1) and 0.356 ± 0.156 min-1 (95% CI: 0.215 to 0.495 min-1), respectively, with statistically significant difference among the groups (low vs intermediate: p = 0.002; intermediate vs high: p = 0.002; low vs high: p < 0.001). The sensitivity and specificity of Ktrans value, 0.14 min-1, to detect the clinically significant prostate cancer were 88% and 93%, respectively, after P4 based error correction, but those before error correction were 88% and 86%, respectively. CONCLUSION: The P4 allows to reduce errors in quantitative dynamic contrast-enhanced magnetic resonance imaging measurement, enhancing accuracy in stratification of prostate cancer grade.

Safety, Tolerability, and Long-Term Clinical Outcomes of an IL-15 analogue (N-803) Admixed with Bacillus Calmette-Guérin (BCG) for the Treatment of Bladder Cancer.

Intravesical BCG is active against non-muscle invasive bladder cancer (NMIBC), but bladder cancer will recur and even progress in a significant number of patients. To improve the response rate, N-803, an IL-15 superagonist was administered in combination with BCG. To evaluate the safety and efficacy associated with the use of intravesical N-803 and BCG in patients with BCG-naïve NMIBC. This phase 1b clinical trial used a 3 + 3 dose-escalation design. Participants were enrolled from July 2014 and July 2015, with follow-up and analyses through January 15, 2021. Eligibility criteria included histologically confirmed non-muscle invasive urothelial carcinoma of intermediate or high risk who had not received prior treatment with intravesical BCG (ie, BCG-naïve). All 9 participants met the eligibility criteria, received treatment according to the protocol, and were included in all analyses. Treatment was done once weekly for 6 consecutive weeks with bladder infusion of the standard dose of BCG, 50 mg/instillation, in combination with increasing doses of N-803 (100, 200, or 400 µg N-803 per instillation). No DLTs were noted in any of the dose cohorts. All adverse events (AEs) were manageable and less than grade 3. During the 2-year follow-up, all 9 participants were disease free. Furthermore, 6 y after treatment, all 9 participants (100%) were disease free with no evidence of disease progression and an intact bladder. This phase 1b trial found the combination of intravesical N-803 and BCG to be associated with modest toxic effects, low immunogenicity, and substantial prolonged antitumoral activity; phase 2 trials are in progress.

Synchronous Malignancies Identified by 18F-fluciclovine Positron Emission Tomography for Prostate Cancer: Case Series and Mini-Review.

Positron emission tomography using the fluorine-18 (18F) fluciclovine radiotracer has been approved for use in recurrent prostate cancer and is a useful tool for clinical decision making. However, 18F-fluciclovine is not specific for prostate cancer tumor cells, and false-positive results have been reported. In the present study, we have reported our experience with synchronous malignancies identified using 18F-fluciclovine and reviewed other reported cases, with a special emphasis on highlighting the clinical decisions that led to the correct diagnosis.

The stanford prostate cancer calculator: Development and external validation of online nomograms incorporating PIRADS scores to predict clinically significant prostate cancer.

BACKGROUND: While multiparametric MRI (mpMRI) has high sensitivity for detection of clinically significant prostate cancer (CSC), false positives and negatives remain common. Calculators that combine mpMRI with clinical variables can improve cancer risk assessment, while providing more accurate predictions for individual patients. We sought to create and externally validate nomograms incorporating Prostate Imaging Reporting and Data System (PIRADS) scores and clinical data to predict the presence of CSC in men of all biopsy backgrounds. METHODS: Data from 2125 men undergoing mpMRI and MR fusion biopsy from 2014 to 2018 at Stanford, Yale, and UAB were prospectively collected. Clinical data included age, race, PSA, biopsy status, PIRADS scores, and prostate volume. A nomogram predicting detection of CSC on targeted or systematic biopsy was created. RESULTS: Biopsy history, Prostate Specific Antigen (PSA) density, PIRADS score of 4 or 5, Caucasian race, and age were significant independent predictors. Our nomogram-the Stanford Prostate Cancer Calculator (SPCC)-combined these factors in a logistic regression to provide stronger predictive accuracy than PSA density or PIRADS alone. Validation of the SPCC using data from Yale and UAB yielded robust AUC values. CONCLUSIONS: The SPCC combines pre-biopsy mpMRI with clinical data to more accurately predict the probability of CSC in men of all biopsy backgrounds. The SPCC demonstrates strong external generalizability with successful validation in two separate institutions. The calculator is available as a free web-based tool that can direct real-time clinical decision-making.

Single-port robotic partial and radical nephrectomies for renal cortical tumors: initial clinical experience.

To describe our institution's initial experience with radical (RN) and partial nephrectomy (PN) using the SP robotic system. The recent FDA approval of the da Vinci® SP robotic platform has led to its use in minimally invasive approaches to urologic malignancies. There are little data on its feasibility and safety after implementation for radical and partial nephrectomy. All patients who underwent PN or RN using the SP system at our institution were reviewed. All PNs were performed off-clamp. Patient demographics, preoperative imaging, operative approaches, and perioperative outcomes were collected and analyzed. Sixteen patients underwent PN (n = 13) or RN (n = 3) utilizing the SP robotic system between January 2019 and June 2019. Average age was 58.6 ± 13.9 and 61.0 ± 1.7 years in each group, respectively. A retroperitoneal approach was performed in 7 (53.8%) PN patients and 1 (33.3%) RN patient. A transperitoneal approach was performed in 6 (46.1%) PNs and 2 (66.7%) RNs. Mean operative time and median estimated blood loss for PN was 176.9 ± 64.0 min and 200 (50-800) ml compared to 176.3 ± 73.8 min and 50 (50-400) ml for RN. There was one operative conversion (7.7%) to an open approach in the PN group. Length of hospital stay postoperatively averaged 1.9 ± 1.3 days and 3.3 ± 1.2 days for patients undergoing partial and radical nephrectomy, respectively. SP partial and radical nephrectomies through transperitoneal and retroperitoneal approaches appear to be feasible surgical techniques in the management of cortical renal masses. Off-clamp PN is also a feasible approach using the SP system. However, further study is needed to establish its safety and use in renal surgery across multiple institutions and larger patient cohorts.