18F-DCFPyL PET/CT for Initially Diagnosed and Biochemically Recurrent Prostate Cancer: Prospective Trial with Pathologic Confirmation.

Background Prostate-specific membrane antigen (PSMA) PET is standard for newly diagnosed high-risk and biochemically recurrent (BCR) prostate cancer. Although studies suggest high specificity of 2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (DCFPyL) for targeting PSMA, false-positive findings have been identified and most studies lack histologic confirmation of malignancy. Purpose To estimate the positive predictive value (PPV) of DCFPyL PET/CT by providing histopathologic proof for DCFPyL-avid lesions suspected of being distant metastases at initial diagnosis and recurrence in BCR prostate cancer. Materials and Methods In this prospective trial, men with newly diagnosed high-risk prostate cancer (sample 1) or BCR prostate cancer and negative findings at conventional CT and/or bone scanning (sample 2) were enrolled between January and December 2021. All men underwent DCFPyL PET/CT. Suspected distant metastases and/or recurrences were biopsied. PPV was calculated. Results A total of 92 men with newly diagnosed prostate cancer (median age, 70 years; IQR, 64-75 years) (sample 1) and 92 men with BCR prostate cancer (median age, 71 years; IQR, 66-75 years) (sample 2) were enrolled. In sample 1, 25 of the 92 men (27%) demonstrated DCFPyL-avid lesions suspicious for distant metastases. Biopsy was performed in 23 of the 25 men (92%), with 17 of the 23 (74%) biopsies positive for malignancy and six (26%) benign. Of the six benign biopsies, three were solitary rib foci and three were solitary pelvic bone foci. In sample 2, 57 of the 92 men (62%) demonstrated DCFPyL-avid lesions suspicious for recurrence. Biopsy was performed in 37 of the 57 men (65%), with 33 of the 37 (89%) biopsies positive for malignancy and four (11%) benign. Of the four benign biopsies, two were subcentimeter pelvic nodes and/or nodules, one was a rib, and one was a pelvic bone focus. Conclusion PET/CT with 2-(3-{1-carboxy-5-[(6-[(18)F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid (DCFPyL) had a high biopsy-proven positive predictive value for distant metastases in newly diagnosed prostate cancer (74%) and for recurrence sites in men with biochemical recurrence (89%). However, there were DCFPyL-avid false-positive findings (particularly in ribs and pelvic bones). Solitary DCFPyL avidity in these locations should not be presumed as malignant. Biopsy may still be needed prior to therapy decisions. ClinicalTrials.gov registration no. NCT04700332 © RSNA, 2022 See also the editorial by Zukotynski and Kuo in this issue.

Polyethylene glycol hydrogel rectal spacer implantation in patients with prostate cancer undergoing combination high-dose-rate brachytherapy and external beam radiotherapy.

PURPOSE: To present rectal toxicity rates in patients administered a polyethylene glycol (PEG) hydrogel rectal spacer in conjunction with combination high-dose-rate brachytherapy and external beam radiotherapy. METHODS AND MATERIALS: Between February 2010 and April 2015, 326 prostate carcinoma patients underwent combination high-dose-rate brachytherapy of 16 Gy (average dose 15.5 Gy; standard deviation [SD] = 1.6 Gy) and external beam radiotherapy of 59.4 Gy (average dose 60.2 Gy; SD = 2.9 Gy). In conjunction with the radiation therapy regimen, each patient was injected with 10 mL of a PEG hydrogel in the anterior perirectal fat space. The injectable spacer (rectal spacer) creates a gap between the prostate and the rectum. The rectum is displaced from the radiation field, and rectal dose is substantially reduced. The goal is a reduction in rectal radiation toxicity. Clinical efficacy was determined by measuring acute and chronic rectal toxicity using the National Cancer Center Institute Common Terminology Criteria for Adverse Events v4.0 grading scheme. RESULTS: Median followup was 16 months. The mean anterior-posterior separation achieved was 1.6 cm (SD = 0.4 cm). Rates of acute Grade 1 and 2 rectal toxicity were 37.4% and 2.8%, respectively. There were no acute Grade 3/4 toxicities. Rates of late Grade 1, 2, and 3 rectal toxicity were 12.7%, 1.4%, and 0.7%, respectively. There were no late Grade 4 toxicities. CONCLUSIONS: PEG rectal spacer implantation is safe and well tolerated. Acute and chronic rectal toxicities are low despite aggressive dose escalation.

Intermediate-term oncologic outcomes of robot-assisted radical cystectomy for urothelial carcinoma.

PURPOSE: To evaluate intermediate-term oncologic outcomes in a large series of patients who were treated with robot-assisted radical cystectomy (RARC) for urothelial carcinoma of the bladder (UCB). PATIENTS AND METHODS: Between 2004 and 2010, 162 patients underwent RARC at City of Hope Cancer Center for UCB and were analyzed with respect to overall (OS), disease-specific (DSS), and disease-free survival (DFS). Descriptive statistics were used to summarize demographics and perioperative variables. The Kaplan-Meier method was used to estimate survival and recurrence. Univariable and multivariable Cox proportional hazards regression models were used to determine predictors of survival. RESULTS: Median follow-up was 52 months. Thirty-eight (23.4%) patients received neoadjuvant chemotherapy before RARC; 28% of patients were pT2 and 33% had final pathology status of pT3 or pT4. Median lymph node count was 28, and positive surgical margin rate was 4.3%. Local recurrence occurred in 11 (6.8%) patients. OS, DFS, and DSS at 3 years were 61%, 76%, and 83%, respectively. OS, DFS, and DSS at 5 years were 54%, 74%, and 80%, respectively. Predictors of OS and DFS on multivariable analysis were lymph node density, pathologic stage, and age-adjusted Charlson Comorbidity Index, while receipt of transfusion was also a negative predictor of OS. CONCLUSIONS: RARC provides an effective means of treatment of UCB in a minimally invasive fashion with comparable oncologic outcomes to that reported in the literature of open procedures.

Early and late complications of robot-assisted radical cystectomy: a standardized analysis by urinary diversion type.

PURPOSE: Minimally invasive surgical treatment for bladder cancer has gained popularity but standardized data on complications are lacking. Urinary diversion type contributes to complications and to our knowledge diversion types after minimally invasive cystectomy have not yet been compared. We evaluated perioperative complications stratified by urinary diversion type in patients treated with robot-assisted radical cystectomy. MATERIALS AND METHODS: We analyzed the records of 209 consecutive patients who underwent robot-assisted radical cystectomy at our institution from 2003 to 2012 with respect to perioperative complications, including severity, time period (early and late) and diversion type. All complications were reviewed by academic urologists. Urinary diversion was also done. As outcome measurements and statistical analysis, univariate and multivariate logistic regression models were used to determine predictors of various complications. RESULTS: The American Society of Anesthesiologists(®) (ASA) score was 3 or greater in 80% of patients and continent diversion was performed in 68%. Median followup was 35 months. Within 90 days 77.5% of patients experienced any complication and 32% experienced a major complication. The 90-day mortality rate was 5.3%. Most complications were gastrointestinal, infectious and hematological. On multivariate analysis patients with ileal conduit diversion had a decreased likelihood of complications compared to patients with Indiana pouch and orthotopic bladder substitute diversion despite the selection of a more comorbid population for conduit diversion. Continent diversion was associated with a higher likelihood of urinary tract infection. Our results are comparable to those of previously reported open and minimally invasive cystectomy series. CONCLUSIONS: Open or minimally invasive cystectomy is a complex, morbid procedure. Urinary diversion is a significant contributor to complications, as is patient comorbidity. Although patients with an ileal conduit had more comorbidities, they experienced fewer complications than those with an orthotopic bladder substitute or Indiana pouch diversion.

Radiation history affects continence outcomes after advance transobturator sling placement in patients with post-prostatectomy incontinence.

OBJECTIVE: To evaluate the effects of preoperative external radiation therapy (XRT) on a cohort of patients who underwent AdVance transobturator urethral sling (ATUS) placement for post-prostatectomy incontinence. METHODS: Thirty-seven patients underwent placement of an ATUS from 2008 to 2010. Patients with and without a history of preoperative XRT were retrospectively compared in regard to their demographical, preoperative, perioperative, and postoperative details. RESULTS: The median follow-up was 17.3 months. Preoperative pad usage was significantly higher in the XRT patient group (P = .03). Overall, 19 patients (51.4%) used no pads, 10 patients (27.0%) were improved, 4 patients (10.8%) had no change, and 4 patients (10.8%) experienced worsening incontinence after the surgery. In patients with and without a history of XRT, 0 (0%) and 19 (63.3%) used no pads, 2 (28.6%) and 8 (26.7%) were improved, 2 (28.6%) and 2 (6.7%) showed no change, and 3 (42.9%) and 1 (3.3%) were worse, respectively. In comparing patients with more severe incontinence preoperatively (>1 pad/day), those with and without radiation, 0 (0%) and 7 (46.7%) used no pads, 2 (28.6%) and 7 (46.7%) were improved, 2 (28.6%) and 0 (0%) had no change, and 3 (42.9%) and 1 (6.7%) were worse, respectively, after ATUS placement. Thus, patients without XRT had an advantage in postoperative pad usage (P = .001), and, furthermore, had improved quality of life (86.2% vs 28.6%, P = .006). CONCLUSION: The ATUS provides excellent continence outcomes in patients suffering from post-prostatectomy urinary incontinence. However, previous pelvic irradiation seems to severely compromise the effectiveness of the ATUS.

Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy.

BACKGROUND: Comprehensive and standardized reporting of adverse events after robot-assisted radical cystectomy (RARC) and urinary diversion for bladder cancer is necessary to evaluate the magnitude of morbidity for this complex operation. OBJECTIVE: To accurately identify and assess postoperative morbidity after RARC using a standardized reporting system. DESIGN, SETTING, AND PARTICIPANTS: A total of 241 consecutive patients underwent RARC, extended pelvic lymph node dissection, and urinary diversion between 2003 and 2011. In all, 196 patients consented to a prospective database, and they are the subject of this report. Continent diversions were performed in 68% of cases. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: All complications within 90 d of surgery were defined and categorized by a five-grade and 10-domain modification of the Clavien system. Univariable and multivariable logistic regression analyses were used to identify predictors of complications. Grade 1-2 complications were categorized as minor, and grade 3-5 complications were categorized as major. All blood transfusions were recorded as grade ≥2. RESULTS AND LIMITATIONS: Eighty percent of patients (156 of 196 patients) experienced a complication of any grade ≤90 d after surgery. A total of 475 adverse events (113 major) were recorded, with 365 adverse events (77%) occurring ≤30 d after surgery. Sixty-eight patients (35%) experienced a major complication within the first 90 d. Other than blood transfusions given (86 patients [43.9%]), infectious, gastrointestinal, and procedural complications were the most common, at 16.2%, 14.1%, and 10.3%, respectively. Age, comorbidity, preoperative hematocrit, estimated blood loss, and length of surgery were predictive of a complication of any grade, while comorbidity, preoperative hematocrit, and orthotopic diversion were predictive of major complications. The 90-d mortality rate was 4.1%. The main limitation is lack of a control group. CONCLUSIONS: Analysis of postoperative morbidity following RARC demonstrates a considerable complication rate, though the rate is comparable to contemporary open series that followed similar reporting guidelines. This finding reinforces the need for complete and standardized reporting when evaluating surgical techniques and comparing published series.

Functional outcomes and complications in patients with bladder cancer undergoing robotic-assisted radical cystectomy with extracorporeal Indiana pouch continent cutaneous urinary diversion.

OBJECTIVE: To evaluate the functional outcomes and complications for patients with bladder cancer undergoing robotic-assisted laparoscopic radical cystectomy with Indiana pouch continent cutaneous urinary diversion. METHODS: From February 2004 to March 2010, 34 patients underwent robotic-assisted laparoscopic radical cystectomy with Indiana pouch continent cutaneous urinary diversion reconstruction. After surgery, the complications were identified, categorized, and graded using an established 5-grade modification of the original Clavien grading system, and continence was assessed. Descriptive statistics were used in evaluating the outcomes. Fischer's exact test was used in the comparison of early and late Clavien grade III complications. RESULTS: Overall, 175 (123 early and 52 late) complications after surgery were reported in 32 (94%) of 34 patients. Within 90 days of surgery, 31 (91%) of 34 patients experienced ≥ 1 early complication. Of 34 patients, 15 (44%) reported ≥ 1 late complications (>90 days). Most (85% and 69%, respectively) early and late complications were graded as minor (grade II or less). Fewer patients with early complications required an additional intervention (grade III) compared with patients with late complications (14% vs 31%; P = .116). The most common complication in both intervals was infection, reported in 22% and 37% of patients with early and late complications, respectively. The continence data for 31 patients at a mean follow-up of 20.1 months (median 12.0) showed that all but 1 patient (97%) had daytime and nighttime continence. CONCLUSION: Patients undergoing robotic-assisted laparoscopic radical cystectomy with Indiana pouch continent cutaneous urinary diversion reconstruction have comparable complication rates and functional outcomes compared with patients in the open series.

Donor Smoking Negatively Affects Donor and Recipient Renal Function following Living Donor Nephrectomy.

Background. While tobacco use by a renal transplant recipient has been shown to negatively affect graft and patient survival, the effect of smoking on the part of the kidney donor remains unknown. Methods. 29 smoking donors (SD) and their recipients (SD-R) as well as 71 non-smoking donors (ND) and their recipients (ND-R) were retrospectively reviewed. Preoperative demographics and perioperative variables including serum creatinine (Cr) and glomerular filtration rate (GFR) were calculated and stratified by amount of tobacco exposure in pack-years. Clinical outcomes were analyzed with a Student's t-test, chi-square, and multiple linear regression analysis (α = 0.05). Results. At most recent followup, SD-R's had a significantly smaller percent decrease in postoperative Cr than ND-R's (-57% versus -81%; P = 0.015) and lower calculated GFR's (37.0 versus 53.0 mL/min per 1.73 m(2); P < 0.001). SD's had a larger percent increase in Cr than ND's at most recent followup (57% versus 40%; P < 0.001), with active smokers having a larger increase than those who quit, although this difference was not statistically significant (68% versus 52%; P = 0.055). Conclusions. Use of tobacco by kidney donors is associated with decreased posttransplant renal function, although smoking cessation can improve outcomes. Kidneys from donors who smoke should be used with caution.

Role of surgery for locally advanced and metastatic renal cell carcinoma.

Both locally advanced and metastatic renal cell carcinoma (RCC) present a challenge in terms of their optimal management. This article reviews the literature and evaluates the role of surgery in the treatment of advanced RCC. Surgery is the optimal treatment for locally advanced RCC and minimal, resectable, metastatic disease. Patients with metastatic disease, and some forms of locally advanced disease, may also benefit from multimodal management with local surgical therapy and systemic treatment using either immunotherapy or targeted therapy. Regardless of the disease stage, patients with locally advanced or metastatic RCC represent heterogenous patient populations with different disease characteristics and risk factors. Individualization of care in the setting of a sound oncologic framework may optimize the risk/benefit ratio within individual patient cohorts.

In vitro comparison of changes in effective patient weight between purely laparoscopic and hand-assisted laparoscopic surgery.

BACKGROUND AND PURPOSE: Subclinical rhabdomyolysis (RM) has been reported to occur at a high frequency in patients who are undergoing hand-assisted laparoscopic (HAL) surgery. Compressive forces of the surgeon's hand pushing the patient down onto the operating table may increase the patient's effective weight, a factor that is correlated with risk of RM. The purpose of this study was to evaluate the changes in effective patient weight during pure laparoscopic (PL) and HAL surgery. MATERIALS AND METHODS: Using an in vitro model, 10 subjects performed translocation and knot tying tasks with both PL and HAL techniques. Changes in weight were monitored using a dynamic industrial scale with real-time digital recording. The means of the average changes in effective weight during the different tasks were compared using the Wilcoxon signed rank test with a P value of <0.05 considered significant. RESULTS: The mean of the average weight increases during translocation was 2.99 kg with HAL compared with 0.06 kg with PL (Z=4.3, P<0.05). The mean average weight increase during knot tying was 1.28 kg in HAL compared with 0.02 kg (Z=2.6, P<0.05) in PL. The mean maximum weight increase was 8.70 kg and 8.01 kg in HAL compared with 0.43 kg and 0.59 kg in PL during translocation and knot tying tasks, respectively (P<0.05 for each). CONCLUSIONS: HAL surgery results in a significant increase in effective patient weight compared with PL surgery. This increased effective weight during HAL surgery may increase the risk for subsequent RM.

Open versus robotic-assisted radical prostatectomy: which is better?

PURPOSE OF REVIEW: Over the last decade there has been a changing trend in technique for radical prostatectomy from open surgery to minimally invasive robotic-assisted laparoscopic technology. This review evaluates the validity of this change by reviewing the current literature and comparing open radical retropubic prostatectomy to robotic-assisted radical prostatectomy. RECENT FINDINGS: Robotic-assisted radical prostatectomy shows equivalent and possibly better results when compared with radical retropubic prostatectomy with respect to intraoperative and postoperative parameters including continence, potency and quality of life. Time is still needed to determine long-term oncologic results, but initial findings are promising. SUMMARY: This review supports the current trend in shifting the standard of care for radical prostatectomy from an open to a robotic-assisted laparoscopic approach.

Intercostal vessels and nerves are at risk for injury during supracostal percutaneous nephrostolithotomy.

PURPOSE: We characterized key intercostal anatomical relationships relevant to supracostal percutaneous nephrostolithotomy using anatomical dissection. MATERIALS AND METHODS: We performed 20 cadaveric dissections of the 11th intercostal space to characterize key anatomical relationships relevant to percutaneous upper pole renal access. Specific data recorded included intercostal rib distance at the lateral border of the paraspinous muscles, and the mid scapular and posterior axillary lines. We also recorded the distance between the 12th and 11th ribs to the intercostal nerve, artery and vein at the same 3 sites. RESULTS: The average intercostal distance was 21, 23 and 26 mm at the lateral border of the paraspinous muscles, and the mid scapular and posterior axillary lines, respectively. The intercostal nerve was exposed to injury in 85%, 100% and 100% of patients at the 3 sites, respectively. The intercostal artery was exposed below the 11th rib in 30%, 60% and 70% of cadavers, respectively, and it was 6 mm from the rib in 25% of interspaces. The intercostal vein, which was exposed below the 11th rib in 0%, 5% and 10% of cadavers, respectively, was least likely to be injured. CONCLUSIONS: Intercostal vessels are at risk for damage during percutaneous nephrostolithotomy in a significant number of patients. Access placement lateral to the paraspinous muscles and in the lower half of the 11th intercostal space may decrease damage to the intercostal artery and nerve. Injury to the intercostal vessels and nerve may explain the increased risk of bleeding and pain during supracostal percutaneous nephrostolithotomy. Minimizing injury may decrease blood loss and pain.

Hand-assisted laparoscopic partial nephrectomy in the porcine model using gelatin matrix hemostatic sealant without hilar occlusion.

BACKGROUND AND PURPOSE: Gelatin matrix hemostatic sealant (GMHS) has been used for hemostasis during partial nephrectomy with hilar clamping. The objective of this study was to determine the ability of GMHS to achieve hemostasis without hilar clamping in the porcine model. MATERIALS AND METHODS: In this feasibility study, eight farm pigs underwent a left-hand-assisted laparoscopic partial nephrectomy (HALPN). The lower fourth of the kidney was removed with cold scissors, and GMHS was applied laparoscopically. Samples were collected for measurement of serum hemoglobin (Hb) and creatinine (Cr) prior to surgery and at 4 and 30 days after HALPN. The kidneys were harvested at 30 days, and retrograde pyelograms and pathologic analysis were performed. RESULTS: Application of GMHS achieved complete hemostasis in all eight animals. The mean estimated blood loss was 40 mL, and the operating time was short (mean 92.5 minutes). In three kidneys, a significant collecting system opening was noted but not repaired. At harvest, there were no hematomas, infections, or urine leaks in any animals. In one animal, a 2-cm contained fluid collection was identified. There was no difference in the preoperative and harvest Hb (9.63 v 9.21 g/dL; P = 0.49), but there was a slight increase in Cr (1.21 v 1.46 mg/dL; P = 0.01) possibly because of the decreased renal mass after partial nephrectomy. CONCLUSION: Even without hilar occlusion, GMHS was 100% safe and effective in controlling bleeding after HALPN in the porcine model. Avoidance of hilar occlusion may reduce the risk associated with warm renal ischemia and the extra dissection required to isolate the hilum in preparation for clamping.