Gleason Grade Group Concordance between Preoperative Targeted Biopsy and Radical Prostatectomy Histopathologic Analysis: A Comparison Between In-Bore MRI-guided and MRI-Transrectal US Fusion Prostate Biopsies.

Purpose: To determine and compare rates of grade group (GG) discrepancies between different targeted biopsy techniques (in-bore vs fusion) after propensity score weighting using whole-mount radical prostatectomy (RP) histopathologic analysis as the reference standard. Materials and Methods: This retrospective study evaluated men who underwent targeted (fusion or in-bore) biopsy between April 2017 and January 2019 followed by prostatectomy. The primary endpoint of the study was a change in GG from biopsy to RP at a patient level. For downgrade and upgrade analysis, men with biopsy GG1 (downgrade not possible) and GG5 (upgrade not possible) were excluded, respectively. GG upgrade, downgrade, and concordance rates of each targeting approach were compared using propensity score weighting and logistic regression with inverse probability of treatment weighting. Significance level was set at .05. Index lesion GG on RP specimen served as the reference standard. Results: A total of 191 men (90 in the in-bore [mean age, 63 years ± 7 (standard deviation)] and 101 in the fusion biopsy group [mean age, 65 years ± 7]) were eligible and included. Fewer GG upgrades were noted in the in-bore biopsy group (14%; 12 of 85) compared with the fusion plus systematic biopsy group (30%; 28 of 93) (P = .012). The incidence of GG downgrade in the in-bore group (25%; 21 of 84) was higher than in the fusion group (17%; 16 of 93); however, the difference was not statistically significant (P = .2). Of the 77 men misclassified by both biopsy techniques, the majority (56%, n = 43) had a change in GG of 2 to 3 or 3 to 2. Conclusion: Superior sampling accuracy with MRI-guided in-bore biopsies offers a lower incidence of GG upgrades compared with MRI-transrectal US fusion biopsies upon RP.Keywords: Biopsy/Needle Aspiration, MR-Imaging, Oncology, Pathology, Prostate Supplemental material is available for this article.© RSNA, 2021.

A Multi-Institutional Phase 2 Trial of High-Dose SAbR for Prostate Cancer Using Rectal Spacer.

PURPOSE: High-dose SABR for prostate cancer offers the radiobiologic potency of the most intensified radiation therapy regimens but was associated with >90% rates of ulceration of the anterior rectal wall on endoscopic assessment; this infrequently progressed to severe rectal toxicity in prior prospective series. A multi-institutional phase 2 prospective trial was conducted to assess whether placement of a perirectal hydrogel spacer would reduce acute periprostatic rectal ulcer events after high-dose (>40 Gy) SABR. METHODS AND MATERIALS: Eligible patients included men with stage ≤T2c localized grade group 1 to 3 prostate cancer, a prostate-specific antigen (PSA) level ≤15 ng/mL, American Urological Association Symptom Index = AUA-SI scores ≤18, and a gland volume ≤80 cm3. Patients underwent perirectal hydrogel spacer placement, followed by SABR of 45 Gy in 5 fractions every other day to the prostate only. Androgen deprivation was not allowed except for cytoreduction. The rectal wall was directly assessed by serial anoscopy during follow-up to determine whether the spacer would reduce acute periprostatic rectal ulcer events from >90% to <70% within 9 months of treatment. RESULTS: Forty-four men were enrolled and 43 were eligible for protocol analysis. The median follow-up for surviving patients was 48 months. Acute periprostatic ulcers were observed in 6 of 42 patients (14.3%; 95% confidence interval, 6.0%-27%; P < .001) at a median of 2.9 months posttreatment (range, 1.7-5.6 months). All ulcers (grade 1, 5 ulcers; grade 2, 1 ulcer) resolved on repeat anoscopy within 8 months of incidence. There were no grade ≥3 late gastrointestinal toxicities; the incidence of late grade-2 gastrointestinal toxicities was 14.3%, with a prevalence at 3 years of 0%. No toxicities greater than grade 3 occurred in any domain. Four-year freedom from biochemical failure was 93.8% (95% CI, 85.2%-100.0%). CONCLUSIONS: Temporary hydrogel spacer placement before high-dose SABR treatment for localized prostate cancer and use of strict dose constraints are associated with a significant reduction in the incidence of rectal ulcer events compared with prior phase 1/2 trial results.

Magnetic Resonance Imaging-guided In-bore and Magnetic Resonance Imaging-transrectal Ultrasound Fusion Targeted Prostate Biopsies: An Adjusted Comparison of Clinically Significant Prostate Cancer Detection Rate.

BACKGROUND: With the increasing adoption of targeted prostate biopsies, it becomes important to understand the strengths and shortcomings of the techniques available for targeting suspicious lesions. OBJECTIVE: To compare clinically significant prostate cancer (csPCa) detection rate with magnetic resonance imaging-transrectal ultrasound (MRI-TRUS) fusion versus in-bore biopsy in men with abnormal multiparametric MRI (mpMRI). DESIGN, SETTING, AND PARTICIPANTS: This single-center, retrospective analysis of prospectively generated data included all men with abnormal mpMRI and fusion or in-bore biopsy between May 2017 and April 2018. Grade group (GG) 2-5 cancers were considered csPCa. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Detection of csPCa was adjusted according to patient- and lesion-related characteristics using propensity score weighting. Secondary endpoints included the detection of clinically insignificant tumors and the rate of GG upgrade from biopsy to prostatectomy specimen. Analyses were performed at patient and lesion levels. RESULTS AND LIMITATIONS: A total of 103 and 300 men were included in the in-bore and fusion cohorts, respectively. On a per-patient basis, in-bore biopsies detected a higher proportion of csPCa (61%, 63/103) than fusion plus systematic biopsies (47%, 141/300; adjusted odds ratio [OR]: 2.1, 95% confidence interval [CI]: 1.6-2.8, p<0.0001). In-bore biopsies also detected fewer (11%, 11/103) clinically insignificant cancers than fusion biopsies (18%, 53/300; OR: 0.5, 95% CI: 0.3-0.8, p=0.001). Of those who had radical prostatectomy, GG upgrade after surgery was seen in 17% (4/24) of the men in the in-bore cohort and in 27% (22/82) of the men in the fusion cohort (p=0.55). CONCLUSIONS: MRI-guided in-bore biopsies detected more clinically significant and fewer insignificant prostate cancers than MRI-TRUS fusion targeted biopsies. Further cost-utility and patient outcome analyses are needed. PATIENT SUMMARY: In-bore biopsies (where the patient is on the magnetic resonance imaging [MRI] scanner itself) detected more aggressive cancers and fewer indolent cancers than fusion (where software blends MRI and ultrasound images) biopsies. These findings may help patients and physicians choose the best biopsy approach.

Optimal sampling scheme in men with abnormal multiparametric MRI undergoing MRI-TRUS fusion prostate biopsy.

OBJECTIVES: To determine the implications of different prostate sampling schemes on the diagnosis of clinically significant prostate cancer (csPCA, ISUP group 2-5) and clinically insignificant prostate cancer (ciPCA, ISUP group 1) in men with abnormal multiparametric magnetic resonance imaging (mpMRI) undergoing MRI-transrectal ulrasound fusion targeted biopsies. MATERIALS AND METHODS: This is a retrospective analysis of a cohort including all men who had a single lesion on mpMRI of the prostate performed between January 2016 and June 2017. All men underwent an MRI-transrectal ulrasound fusion biopsy and systematic (SBx) sampling of the prostate, which combined and were considered the standard of reference. The hypothetical 3 biopsy sampling schemes were defined as follows: Targeted biopsy only (TBx), TBx + ipsilateral SBx (ipsi-SBx) and TBx + contralateral SBx (contra-SBx) and were evaluated for the detection of csPCA and ciPCA. Sensitivity and 95% intervals were calculated, McNemar test was used to compare sensitivities between the various sampling schemes. RESULTS: TBx + SBx detected csPCa in 47% (55 of 116) of the 116 men who met eligibility criteria. Sensitivity and 95% confidence intervals for csPCa detection was 85.5% (73.3%-93.5%), 96.4% (87.5%-99.6%), and 92.7 (82.4%-98%) for TBx alone, TBx + ipsi-SBx and TBx + contra-SBx, respectively. csPCa detection rates were higher for both TBx + ipsi-SBx and TBx + contra-SBx compared to TBx alone. Clinically insignificant cancers alone were detected in 7.7% (9 of 116), 10.3% (12 of 116), and 14.6% (17 of 116) of the cohort by TBx only and TBx + ipsi-SBx, and TBx + contra-SBx, respectively. CONCLUSIONS: TBx + ipsi-SBx may increase the detection of csPCa while limiting overdiagnosis of indolent cancers.

Prospective Monitoring and Adapting Strategies for Prevention of Infection Following Transrectal Prostate Procedures.

INTRODUCTION: A number of strategies have been attempted to minimize infection risk following transrectal prostate procedures (TRPXs). We report our prospective efforts at augmenting our prophylaxis strategy over time. METHODS: Since 2010, we prospectively monitor post-TRPX infections and changed our prophylaxis regimen twice in an effort to respond to increases in infectious complications. In 2011 we added a single-dose of intramuscular (IM) aminoglycoside to our prophylaxis regimen of fluoroquinolones (FQ) or trimethoprim-sulfamethoxazole. In 2015 we began performing formalin needle-tip disinfection before each biopsy and screening high-risk patients for antibiotic resistance using rectal swab cultures (targeted prophylaxis). We report our rates of infections and antibiotic resistance patterns over this period. RESULTS: From 2010-2016, we performed 2398 TRPXs; overall, there were 41 cases (1.7%) of infection-related hospitalization, however the rate differed significantly over the study period. The infection-related hospitalization rate declined from 3.8 to 1.1% in the first 3 years following the addition of IM aminoglycoside (2011-2013) - a decrease of 69%. In 2014 our infection rate increased to 2.6% prompting initiation of protocol #3 wherein the addition of target prophylaxis and formalin needle-tip disinfection identified a 29.8% FQ-resistance rate and resulted in another decline in our infection rate to 1.2% - a decrease of 53%. CONCLUSIONS: While the initial addition of IM aminoglycoside appeared to be effective in decreasing post-procedure infections, further augmentation of our prophylaxis regimen through rectal swab screening of high-risk patients and formalin needle-tip disinfection led to an additional decline in rates of infection-related hospitalizations.

Dosimetric comparison of rectal-sparing capabilities of rectal balloon vs injectable spacer gel in stereotactic body radiation therapy for prostate cancer: lessons learned from prospective trials.

This study aimed to compare the rectal-sparing capabilities of rectal balloons vs absorbable injectable spacer gel in stereotactic body radiation therapy (SBRT) for prostate cancer. Patient samples included in this analysis were obtained from 2 multi-institutional prospective trials of SBRT for prostate cancer using a rectal balloon (n = 36 patients) and injectable spacer gel (n = 36). Treatment prescription dose was 45 Gy in 5 fractions in 42 patients; for equal comparison, the remaining 30 patients were rescaled to 45 Gy from 47.5 Gy prescription (n = 6) and 50 Gy prescription (n = 24). The median prostate volumes and body mass index in the 2 patient samples were not statistically significantly different (p= 0.67 and 0.45, respectively), supporting anatomic similarity between cohorts. The injectable spacer gel achieved dosimetric superiority over the rectal balloon with respect to the maximum dose to the rectum (42.3 vs 46.2 Gy, p < 0.001), dose delivered to 33% of the rectal circumference (28 vs 35.1 Gy, p < 0.001), and absolute volume of rectum receiving 45 Gy (V45Gy), V40Gy, and V30Gy (0.3 vs 1.7 cc, 1 vs 5.4 cc, and 4.1 vs 9.6 cc, respectively; p < 0.001 in all cases). There was no difference between the 2 groups with respect to the V50Gy of the rectum or the dose to 50% of the rectal circumference (p= 0.29 and 0.06, respectively). The V18.3Gy of the bladder was significantly larger with the rectal balloon (19.9 vs 14.5 cc, p= 0.003). In this analysis of patients enrolled on 2 consecutive multi-institutional prospective trials of SBRT for prostate cancer, the injectable spacer gel outperformed the rectal balloon in the majority of the examined and relevant dosimetric rectal-sparing parameters. The rectal balloon did not outperform the injectable spacer gel in any measured rectal dose parameter.

Beyond the PSA test: How to better stratify a patient's risk of prostate cancer.

The primary method of screening for and detecting prostate cancer is the prostate-specific antigen (PSA) test. Although this test is very prostate-specific, it is not cancer-specific; conditions other than prostate cancer can cause an elevated PSA. Many efforts have been made to discover more specific tests and methods beyond the PSA. This article describes several literature-supported tests and methods to better stratify a man's risk of having prostate cancer.

The Expanding Role of Advanced Practice Providers in Urologic Procedural Care.

OBJECTIVE: To understand the role of Advanced Practice Providers (APPs) in urologic procedural care and its change over time. As the population ages and the urologic workforce struggles to meet patient access demands, the role of APPs in the provision of all aspects of urologic care is increasing. However, little is currently known about their role in procedural care. MATERIALS AND METHODS: Commonly performed urologic procedures were linked to Current Procedural Terminology (CPT) codes from 1994 to 2012. National Medicare Part B beneficiary claims frequency was identified using Physician Supplier Procedure Summary Master Files. Trends were studied for APPs, urologists, and all other providers nationally across numerous procedures spanning complexity, acuity, and technical skill set requirements. RESULTS: Between 1994 and 2012, annual Medicare claims for urologic procedures by APPs increased dramatically. Cystoscopy increased from 24 to 1820 (+7483%), transrectal prostate biopsy from 17 to 834 (+4806%), complex Foley catheter placement from 471 to 2929 (+522%), urodynamics testing from 41 to 9358 (+22,727%), and renal ultrasound from 18 to 4500 (+24,900%) CONCLUSION: We found dramatic growth in the provision of urologic procedural care by APPs over the past 2 decades. These data reinforce the known expansion of the APP role in urology and support the timeliness of ongoing collaborative multidisciplinary educational efforts to address unmet needs in education, training, and guideline formation to maximize access to urologic procedural services.

An initial negative round of targeted biopsies in men with highly suspicious multiparametric magnetic resonance findings does not exclude clinically significant prostate cancer-Preliminary experience.

BACKGROUND: Targeted prostate biopsies are changing the landscape of prostate cancer (PCa) diagnosis with the degree of suspicion on multiparametric magnetic resonance imaging (mpMRI) being a strong predictor of targeted biopsy outcome. Data regarding the rate and potential causes of false-negative magnetic resonance imaging-transrectal ultrasound (MRI-TRUS) fusion-targeted biopsy in patients with highly suspicious mpMRI findings are lacking. OBJECTIVES: To determine the rate of clinically significant PCa detection in repeat targeted biopsy or surgery in patients with highly suspicious mpMRI findings and in an initial negative MRI-TRUS fusion-targeted biopsy. MATERIALS AND METHODS: In this single-center, retrospective study of prospectively generated data, men with highly suspicious lesions (Likert 5 score) on mpMRI and an initial negative MRI-TRUS fusion-targeted biopsy were reviewed. The rate of PCa detection in a subsequent MRI-TRUS fusion-targeted biopsy or radical prostatectomy was determined. Tumors in the intermediate- and high-risk groups according to the National Comprehensive Cancer Network criteria were considered clinically significant. RESULTS: A total of 32 men with 38 Likert 5 lesions were identified. Repeat targeted biopsy or surgery detected cancer in 42% (16/38) of the Likert 5 lesions with initial negative targeted biopsy. Most of these cancers were intermediate- (69%; 11/16) or high-risk (25%; 4/16) tumors. CONCLUSION: A negative round of targeted biopsies does not exclude clinically significant PCa in men with highly suspicious mpMRI findings. Patients with imaging-pathology disagreement should be carefully reviewed and considered for repeat biopsy or for strict surveillance.

The current state of prostate-specific antigen testing.

Since prostate-specific antigen (PSA) testing was approved in 1994, the incidence of metastasis and mortality from prostate cancer have significantly decreased. However, PSA screening for prostate cancer has limitations and few large randomized controlled trials have been conducted to determine the mortality benefit of PSA screening. Two studies that have been conducted are the Prostate, Lung, Colorectal, and Ovarian (PLCO) screening trial and the European Randomized Study of Screening for Prostate Cancer (ERSPC). These were the two main studies the US Preventive Services Task Force (USPSTF) used in its recommendation against prostate cancer screening in 2012. However, new evidence has demonstrated that the PLCO trial had significant limitations and the results of the ERSPC trial were more significant than previously thought. This article describes the strengths and weaknesses of the USPSTF's recommendation, along with current guidelines for prostate cancer screening.

Assessment of Prospectively Assigned Likert Scores for Targeted Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Biopsies in Patients with Suspected Prostate Cancer.

PURPOSE: We assess the performance of prospectively assigned magnetic resonance imaging based Likert scale scores for the detection of clinically significant prostate cancer, and analyze the pre-biopsy imaging variables associated with increased cancer detection using targeted magnetic resonance imaging-transrectal ultrasound fusion biopsy. MATERIALS AND METHODS: In this retrospective review of prospectively generated data including men with abnormal multiparametric prostate magnetic resonance imaging (at least 1 Likert score 3 or greater lesion) who underwent subsequent targeted magnetic resonance imaging-transrectal ultrasound fusion biopsy, we determined the association between different imaging variables (Likert score, lesion size, lesion location, prostate volume, radiologist experience) and targeted biopsy positivity rate. We also compared the detection of clinically significant cancer according to Likert scale scores. Tumors with high volume (50% or more of any core) Gleason score 3+4 or any tumor with greater Gleason score were considered clinically significant. Each lesion served as the elementary unit for analysis. We used logistic regression for univariate and multivariate (stepwise selection) analysis to assess for an association between targeted biopsy positivity rate and each tested variable. The relationship between Likert scale and Gleason score was evaluated using the Spearman correlation coefficient. RESULTS: A total of 161 men with 244 lesions met the study eligibility criteria. Targeted biopsies diagnosed cancer in 41% (66 of 161) of the men and 41% (99 of 244) of the lesions. The Likert score was the strongest predictor of targeted biopsy positivity (OR 3.7, p <0.0001). Other imaging findings associated with a higher targeted biopsy positivity rate included smaller prostate volume (OR 0.7, p <0.01), larger lesion size (OR 2.2, p <0.001) and anterior location (OR 2.0, p=0.01). On multiple logistic regression analysis Likert score, lesion size and prostate volume were significant predictors of targeted biopsy positivity. Higher Likert scores were also associated with increased detection of clinically significant tumors (p <0.0001). CONCLUSIONS: The Likert scale score used to convey the degree of suspicion on multiparametric magnetic resonance imaging is the strongest predictor of targeted biopsy positivity and of the presence of clinically significant tumor.

Reduction in hospital admission rates due to post-prostate biopsy infections after augmenting standard antibiotic prophylaxis.

PURPOSE: We evaluated the incidence of infectious complications requiring hospitalization after transrectal ultrasound guided prostate biopsy, comparing an augmented regimen of antibiotic prophylaxis to the standard regimen, and established cost-effectiveness at our center. MATERIALS AND METHODS: Our standard antibiotic prophylaxis regimen consisted of 3 days of ciprofloxacin or Bactrim™ DS in the perioperative period. An increase in hospital admissions related to infection after transrectal ultrasound guided biopsy from January 2010 through December 2010 led us to initiate an augmented regimen of 3 days of ciprofloxacin or Bactrim DS in addition to 1 dose of intramuscular gentamicin before biopsy from January 2011 to December 2011. Urine and blood cultures along with bacterial susceptibilities were obtained at admission and compared between the 2 groups. Cost analysis was done to determine the cost-effectiveness of standard and augmented regimens. RESULTS: The rate of hospitalization due to post-biopsy infections was 3.8% (11 patients among 290 biopsies) in 2010, which decreased to 0.6% (2 patients among 310 biopsies) in 2011 (p <0.001). Of the admitted patients who received standard prophylaxis, 73% had fluoroquinolone resistant Escherichia coli urinary infection and/or bacteremia and only 9% had strains resistant to gentamicin. Multivariate analysis showed that the standard regimen was significantly associated with hospital admission due to post-biopsy infection (HR 2.078 ± 0.84, p = 0.013). The augmented regimen resulted in a cost savings of $15,700 per 100 patients compared to the standard regimen. CONCLUSIONS: The addition of gentamicin to current prophylactic regimens significantly reduced the rate of hospitalization for post-biopsy infectious complications and was shown to be cost-effective.

Idiopathic scrotal elephantiasis.

Scrotal lymphedema (scrotal elephantiasis) is a condition that has historically been described in areas endemic to filariasis. We present a unique case of a 22-year-old man with idiopathic lymphedema isolated to the scrotum. After acquired causes of lymphedema were ruled out, the patient was treated with scrotectomy and scrotal reconstruction.