28 Radiation-induced fistulas after pelvic radiation therapy: a systematic review and meta-analysis.

Objectives: Little is known about the prevalence of fistulas in patients with exposure to pelvic radiotherapy. The purpose of this systematic review and meta-analysis is to aggregate and summarize existing cohort study data on fistula prevalence among patients with a history of pelvic radiotherapy for pelvic malignancy. Materials and Methods: We queried PubMed, Embase, and Web of Science for studies pertaining to radiation induced fistulas in the pelvis. For this abstract, we included cohort studies reporting fistula prevalence among patients exposed to pelvic radiotherapy for the treatment of pelvic malignancy. We conducted meta-analysis using the fixed-effects model. We used I 2 statistic to assess heterogeneity and the Newcastle-Ottawa Scale to assess risk of bias. PRISMA guidelines were followed, and our protocol was registered a priori on PROSPERO (CRD42020214451). Results: We included 17 cohort studies with a total of 1,371 patients exposed to pelvic radiotherapy between 1983 and 2019. Mean patient age was 57.7 years and mean follow-up time was 32.5 months. The studies reported data on patients with cancer of the cervix (n=852), prostate (n=266), rectum (n=91), and multiple Abstract Objective : To assess temporal changes in the race-specific rates of PSA screening, prostate biopsy, incident prostate cancer detection, and metastatic cancer at presentation among screen-eligible men in Kaiser Permanente Northern California before and after the 2012 the United States Preventive Services Task Force Prostate Cancer Screening Statement. Materials and Methods : This was a retrospective study spanning the years 2006 to 2017, in screen-eligible Kaiser Permanente Northern California members (Black men ages 45-69, all other men ages 50-69) with no prior history of prostate cancer. The number of screen-eligible men served as the denominator for all rate calculations. We compared the race-specific biennial rates of PSA testing, prostate biopsy, incident prostate cancer detection, and metastatic cancer at presentation. Results : 422,664 to 567,660 total men per biennial period were evaluated (72% White, 8% Black, 20% Asian). Following the 2012 United States Preventive Services Task Force statement, all races experienced similar declines in screening (22-25%; Figure 1), biopsy (47-57%) and overall cancer detection (34-48%) rates. We found an increase in metastatic rates (39-105%) in all races (Figure 2). Uncaptioned visual Uncaptioned visual White are referent for all comparisons of rate ratios; tan colored numbers are statistically significantly different from referent, p<0.05 Conclusions : Following the 2012 Statement, in men under the age of 70, PSA screening, biopsy and incident prostate cancer-detection rates significantly decreased in a similar fashion across all races, while rates of metastatic disease significantly increased in all races. Abstract Objective: To prospectively validate a new prostate cancer risk calculator in a racially diverse population. Materials and Methods: We recently developed, internally validated and published the Kaiser Permanente Prostate Cancer Risk Calculator. This study is a prospective validation of the calculator in a separate, referral population over a 21-month period. All patients were tested with a uniform PSA assay and a standardized systematic, ultrasound-guided biopsy scheme. We report on 3 calculator models: Model 1 included age, race, PSA, prior biopsy status, body mass index, and family history of prostate cancer; Model 2 added digital rectal exam to Model 1 variables; Model 3 added prostate volume to Model 2 variables. We considered three outcomes: high-grade disease (Gleason score >7), low-grade disease (Gleason score=6), and no cancer. Predictive discrimination and calibration were calculated. How each model might alter biopsy frequency and outcomes at various thresholds of risk was assessed. We compared the performance of our calculator with two other calculators. Results: In 4178 patients (16.2% Asian, 11.3% African American, 13.5% Hispanic), cancer was found in 53%; 62% were Gleason score >7. Using a high-grade risk threshold for biopsy of >10%, Model 2 predictions would result in 9% of men avoiding a biopsy, while only missing 2% of high-grade cancers. At the same threshold, Model 3 predictions would result in 26% of men avoiding a biopsy, while only missing 5% of high-grade cancers. The c-statistics for Models 1, 2, and 3 to predict high-grade disease vs. low-grade or no cancer were 0.76, 0.79 and 0.85, respectively. The c-statistics for Models 1, 2, and 3 to predict any prostate cancer vs. no cancer were 0.70, 0.72 and 0.80, respectively. All models were well calibrated for all outcomes. Our Model 3 calculator had superior discrimination for high grade disease (c-statistic=0.85, 0.84-0.86) and any cancer (0.80, 0.79-0.82) compared to the PBCG calculator [(0.79, 0.78-0.80); 0.72 (0.70-0.73)] and the PCPT calculator [(0.75, 0.74-0.77); 0.69 (0.67-0.70)], respectively. In the high-grade cancer predicted risk range of 0-30%, our Model 2 was better calibrated than the PCPT and PBCG calculators. Abstract Introduction : This study evaluated the ability of the combined clinical cell-cycle risk score (CCR) to prognosticate the risk of prostate cancer metastasis in men receiving dose-escalated radiation therapy (RT) with or without androgen deprivation therapy (ADT). Methods : The CCR score is a validated model that combines the cell cycle progression score (CCP) with the UCSF Cancer of the Prostate Risk Assessment score (CAPRA). The CCR score and a CCR-based multimodality threshold score (2.112) were evaluated in a retrospective, multi-institutional cohort of men with National Comprehensive Cancer Center (NCCN) intermediate- or high-risk localized disease (N=741) who received single (RT)- or multimodality therapy (ADT with RT). Effects of prognostic variables were analyzed using Kaplan-Meier and Cox regression methods. of metastasis Abstract Objectives Sabizabulin is a novel oral agent that targets microtubules to disrupt transport of AR. A Phase 1b/2 clinical study was conducted to assess safety, maximum tolerated dose and efficacy in men with mCRPC that progressed on an ARTA. A Phase 1b/2 study was conducted in men with mCRPC who have failed an ARTA. The Phase 1b portion (n=39) utilized a 3+3 design with escalating oral dosing of 4.5 mg to 81 mg for 7 days on /14 days off drug per 21-day cycle, then was expanded to continuous daily dosing. The Phase 2 portion (n=41) evaluated the recommended Phase 2 dose (63 mg PO daily). A PK study evaluating the Phase 2 and Phase 3 trial dosage forms was also conducted. Abstract Objectives : Validated skills assessment tools have the potential to help trainees understand their progress. Herein, we aimed to exhaustively map out all relevant sub-skills of suturing and to define criteria around said sub-skills to differentiate performance. Abstract Oral glucocorticoids (steroids) are among the most commonly prescribed medications, with a large proportion of patients being chronic users. Steroids regulate diverse cellular functions and have cross-talk with androgen receptors, potentially propagating androgen independent prostate cancer (PCa). We aimed to examine the relationship between exposure to steroids and advanced PCa at presentation with a methodology to limit detection bias. Methods We queried the linked SEER-Medicare database to identify PSA screened patients diagnosed with PCa. Criteria for screening included a PSA lab test or DRE exam in both the 12 month AND 13-36 month periods prior to diagnosis of PCa. SEER-Medicare Part D prescription drug claims were used to identify steroid exposure. Steroid use was divided into exposure groups based on duration of use in the 3 years prior to diagnosis: controls with no exposure, <30 days, 30d-1yr, 1-2yrs, and >2+ years. Advanced PCa was defined as de novo systemic metastases or regional lymph node metastasis at presentation. Risk estimates of the likelihood of advanced PCa at presentation for steroid exposure groups vs. controls were estimated in univariate and multivariate (MV) logistic regression models adjusting for age, race, and comorbidities. Dose response was evaluated in analogous MV regression analysis with duration of steroid use as a continuous variable (days). We identified PCa of 28.96% Both univariate and MV for advanced PCa Abstract Background: PSMA-targeted PET/CT is a new imaging modality for prostate cancer (PCa) detection and localization. Piflufolastat F 18 (PYLARIFY ® ; previously known as 18 F-DCFPyL) is a novel PSMA targeted radiotracer recently approved by the FDA for imaging men at risk for metastasis prior to initial treatment and recurrence following prior therapy. OSPREY and CONDOR were prospective multicenter clinical trials designed to determine the safety and diagnostic performance of piflufolastat-PET/CT in the initial and recurrent disease setting respectively. Methods: In OSPREY, piflufolastat was evaluated in men with high-risk PCa who were planned for radical prostatectomy with lymphadenectomy (Cohort A, n=268). Co-primary endpoints were specificity and sensitivity for detecting metastases in pelvic lymph nodes (PLNs). The CONDOR primary endpoint was correct localization rate (CLR) defined as PPV with correct anatomic lesion co-localization between piflufolastat and the standard of truth in men with BCR and uninformative conventional imaging. For both studies, 9 mCi (333 MBq) of piflufolastat was administered 1-2 hours prior to PET/CT. Results: For OSPREY Cohort A (n=252 evaluable), piflufolastat-PET/CT demonstrated a sensitivity among the three readers ranging from 30.6-41.9% (lower bound of 95% CI: 19.2-29.7%), specificity of 96.3-98.9% (lower bound of 95% CI: 93.6-96.0%), and PPV and NPV ranging from 78.1-90.5% (lower bound of 95% CI: 63.8-69.9%) and 81.4-83.8% (lower bound of 95% CI: 76.4-78.9%), respectively. For CONDOR, 208 men (median PSA 0.8 [