Identification of Preference "Phenotypes" in Men With Prostate Cancer.

INTRODUCTION: Patient preference assessment is key to high-quality decision-making in men with prostate cancer. We aimed to determine if "phenotypes" could be identified among men with prostate cancer, with each phenotype representing a cohort with a distinct combination of preferences. We wished to learn if there was an association between phenotype and treatment selection. METHODS: A prospective cohort of men with prostate cancer received a pre-visit decision aid. This software used conjoint analysis to quantify relative patient preferences for treatment-associated survival, quality of life outcomes, and recovery time. We collected patient clinical data, physician recommendation for active treatment or surveillance, and treatments received. Preferences were analyzed using latent class analysis to identify distinct classes of preference phenotypes. We compared patient characteristics and treatment choice across phenotypes, both univariately and in a multivariable logistic regression. RESULTS: In 250 men who used the decision aid as part of routine care, latent class analysis revealed 3 phenotypic classes. Men in Class 1 had the highest concerns around recovery time and the lowest value on improving lifespan. Men in Class 2 had relatively evenly distributed concerns. Men in Class 3 had the lowest concerns around recovery time and risk of surgical complications. On multivariate analysis, treatment choice was not associated with preference-based phenotype. Only physician recommendation was associated with choice of active treatment. CONCLUSIONS: We identified the existence of 3 patient preference-based phenotypes in men with prostate cancer. Each phenotype had a unique combination of trade-offs when considering competing treatment outcomes. These phenotypes were not associated with treatment. Physician recommendation was the only factor determining treatment choice.

Impact of Gabapentin on Postoperative Hypotension in Enhanced Recovery after Surgery Protocols for Microvascular Breast Reconstruction.

Background: Enhanced recovery after surgery (ERAS) protocols have been associated with hypotensive episodes after autologous breast reconstruction. Gabapentin (Gaba), a nonopioid analgesic used in ERAS, has been shown to attenuate postoperative hemodynamic responses. This study assesses ERAS's impact, with and without Gaba, on postoperative hypotension after microvascular breast reconstruction. Methods: Three cohorts were studied: traditional pathway, ERAS + Gaba, and ERAS no-Gaba. We evaluated length of stay, inpatient narcotic use [morphine milligram equivalents (MME)], mean systolic blood pressure, hypotension incidence, and complications. The traditional cohort was retrospectively reviewed, whereas the ERAS groups were enrolled prospectively after the initiation of the protocol in April 2019 (inclusive of Gaba until October 2022). Results: In total, 441 patients were analyzed. The three cohorts, in the order mentioned above, were similar in age and bilateral reconstruction rates (57% versus 61% versus 60%). The ERAS cohorts, both with and without Gaba, had shorter stays (P < 0.01). Inpatient MME was significantly less in the ERAS + Gaba cohort than the traditional or ERAS no-Gaba cohorts (medians: 112 versus 178 versus 158 MME, P < 0.01). ERAS + Gaba significantly increased postoperative hypotensive events on postoperative day (POD) 1 and 2, with notable reduction after Gaba removal (P < 0.05). Across PODs 0-2, mean systolic blood pressure was highest in the traditional cohort, followed by ERAS no-Gaba, then the ERAS + Gaba cohort (P < 0.05). Complication rates were similar across all cohorts. Conclusions: Postmicrovascular breast reconstruction, ERAS + Gaba reduced overall inpatient narcotic usage, but increased hypotension incidence. Gaba removal from the ERAS protocol reduced postoperative hypotension incidence while maintaining similar stay lengths and complication rates.

Determination of Whole Blood Loss From Minimally Invasive Myomectomy Using a Standardized Formula: A Pilot Study.

STUDY OBJECTIVE: To determine the median perioperative blood loss (PBL) during minimally invasive surgical (MIS) myomectomy. DESIGN: Prospective pilot study. SETTING: Large academic teaching hospital. PATIENTS: Thirty-one patients underwent laparoscopic or robotic myomectomy and completed a postoperative complete blood count (CBC) from November 2020 to August 2022. Patients had to have at least one fibroid greater than or equal to 3 cm on preoperative imaging. INTERVENTIONS: A CBC was collected preoperatively within 7 days of surgery. Estimated blood loss (EBL) was determined by the surgeon intraoperatively. A repeat CBC was drawn between postoperative days 2 through 4. PBL was calculated using the equation PBL = (patient weight in kg × 65 cc/kg) × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit. MEASUREMENTS AND MAIN RESULTS: Median PBL (536.3 cc [270.0, 909.3]) was greater than median EBL (200.0 cc [75.0, 500.0]). PBL ranged from a net gain of 191.5 cc to net loss of 2362.5 cc. Median size of the largest fibroid on preoperative imaging was 8.8 cm (6.6, 11.5), and median weight of fibroids removed was 321 g (115, 519). About half of patients (51.6%) had one fibroid removed, and 48.4% had 2 or more fibroids removed. Five patients were converted to laparotomy, 4 from robotic approaches. Two patients required a blood transfusion. CONCLUSION: Calculated PBL was greater than intraoperative EBL. This suggests there is continued blood loss post myometrial bed closure. Blood loss should be evaluated both during and after myomectomy, as intraoperative EBL underestimates total PBL.

Neighborhood Deprivation, Race and Ethnicity, and Prostate Cancer Outcomes Across California Health Care Systems.

Importance: Non-Hispanic Black (hereafter, Black) individuals experience worse prostate cancer outcomes due to socioeconomic and racial inequities of access to care. Few studies have empirically evaluated these disparities across different health care systems. Objective: To describe the racial and ethnic and neighborhood socioeconomic status (nSES) disparities among residents of the same communities who receive prostate cancer care in the US Department of Veterans Affairs (VA) health care system vs other settings. Design, Setting, and Participants: This cohort study obtained data from the VA Central Cancer Registry for veterans with prostate cancer who received care within the VA Greater Los Angeles Healthcare System (VA cohort) and from the California Cancer Registry (CCR) for nonveterans who received care outside the VA setting (CCR cohort). The cohorts consisted of all males with incident prostate cancer who were living within the same US Census tracts. These individuals received care between 2000 and 2018 and were followed up until death from any cause or censoring on December 31, 2018. Data analyses were conducted between September 2022 and December 2023. Exposures: Health care setting, self-identified race and ethnicity (SIRE), and nSES. Main Outcomes and Measures: The primary outcome was all-cause mortality (ACM). Cox proportional hazards regression models were used to estimate hazard ratios for associations of SIRE and nSES with prostate cancer outcomes in the VA and CCR cohorts. Results: Included in the analysis were 49 461 males with prostate cancer. Of these, 1881 males were in the VA cohort (mean [SD] age, 65.3 [7.7] years; 833 Black individuals [44.3%], 694 non-Hispanic White [hereafter, White] individuals [36.9%], and 354 individuals [18.8%] of other or unknown race). A total of 47 580 individuals were in the CCR cohort (mean [SD] age, 67.0 [9.6] years; 8183 Black individuals [17.2%], 26 206 White individuals [55.1%], and 13 191 individuals [27.8%] of other or unknown race). In the VA cohort, there were no racial disparities observed for metastasis, ACM, or prostate cancer-specific mortality (PCSM). However, in the CCR cohort, the racial disparities were observed for metastasis (adjusted odds ratio [AOR], 1.36; 95% CI, 1.22-1.52), ACM (adjusted hazard ratio [AHR], 1.13; 95% CI, 1.04-1.24), and PCSM (AHR, 1.15; 95% CI, 1.05-1.25). Heterogeneity was observed for the racial disparity in ACM in the VA vs CCR cohorts (AHR, 0.90 [95% CI, 0.76-1.06] vs 1.13 [95% CI, 1.04-1.24]; P = .01). No evidence of nSES disparities was observed for any prostate cancer outcomes in the VA cohort. However, in the CCR cohort, heterogeneity was observed for nSES disparities with ACM (AHR, 0.82; 95% CI, 0.80-0.84; P = .002) and PCSM (AHR, 0.86; 95% CI, 0.82-0.89; P = .007). Conclusions and Relevance: Results of this study suggest that racial and nSES disparities were wider among patients seeking care outside of the VA health care system. Health systems-related interventions that address access barriers may mitigate racial and socioeconomic disparities in prostate cancer.

Impact of mastectomy flap necrosis on prepectoral reconstructive outcomes.

INTRODUCTION: As reconstructive surgeons have increasingly transitioned to the prepectoral plane for prosthetic breast reconstruction, the implications of mastectomy skin flap necrosis have become more concerning. Our goal was to evaluate the effect of skin flap necrosis on reconstructive outcomes in patients undergoing immediate prepectoral breast reconstruction. METHODS: A retrospective review was conducted of patients undergoing immediate two-stage prepectoral reconstruction at a single center with at least 3 months follow-up. Postoperative complications, reconstructive outcome, and time to final implant were compared between patients with and without mastectomy skin necrosis. RESULTS: A total of 301 patients underwent 509 prepectoral breast reconstructions. Forty-four patients (14.6%) experienced postoperative mastectomy skin flap necrosis. Demographic and reconstructive characteristics were similar between the necrosis and no necrosis cohorts. Patients with skin necrosis were more likely to undergo reoperation after tissue expander (64% vs 19%, p < 0.01) and undergo expander replacement (13.6% vs 3.5%, p = 0.02). However, rates of reconstructive failure (6.8% vs 6.2%), major infection (9.1% vs 9.0%), and minor infection (13.6% vs 17.5%) after expander placement were statistically similar. Patients with skin necrosis trended toward longer time before final implant placement, although the difference was not statistically significant (6.5 vs 5.0 months, p = 0.08). There was no difference in complication rates between the necrosis and no necrosis cohort after final implant placement. There was a higher rate of revision surgery after implant placement in the necrosis cohort (12.5% vs 4.1%, p = 0.047). CONCLUSIONS: Mastectomy skin flap necrosis is a concerning postoperative event, particularly in patients with prepectoral prostheses. We observed that patients with skin necrosis experience higher reoperation rates in the expander period, yet have similar infection rates and achieve similar final reconstructive outcomes compared to patients without necrosis.

Gender-Affirming Mastectomy: Psychosocial and Surgical Outcomes in Transgender Adults.

BACKGROUND: Limited literature exists examining the effects of gender-affirming mastectomy on transmasculine and nonbinary patients that is prospective and uses validated survey instruments. STUDY DESIGN: The psychosocial functioning of transmasculine and nonbinary patients was compared between patients who underwent gender-affirming mastectomy and those who had not yet undergone surgery. Participants were enrolled in a single-site, combined study of surgical and psychosocial outcomes, including a cross-sectional cohort of preoperative and postoperative patients, as well as separate prospective cohort. Participants completed the BREAST-Q psychosocial and sexual well-being modules, the BODY-Q satisfaction with chest and nipples modules, the Body Image Quality of Life Inventory, the Transgender Congruence Scale, the Patient Health Questionnaire-9, and the Generalized Anxiety Disorder-7 scale before and after surgery. We also examined how patient demographic factors correlated with postoperative surgical and psychosocial outcomes. RESULTS: A total of 111 transmasculine and nonbinary patients 18 to 63 years of age (mean ± SD 26.5 ± 8) underwent mastectomy and were included in the study. All were included in the cross-sectional cohort, and 20 were enrolled in the prospective cohort. More than one-third (34.2%) of patients were nonbinary. After surgery, psychosocial and sexual well-being, satisfaction, body image-related quality of life, and gender congruence were increased (p < 0.001) in both cohorts, and depression (p < 0.009 cross-sectional), and anxiety (p < 0.001 cross-sectional) were decreased. The most common adverse event was hypertrophic scarring, which occurred in 41 (36.9%) participants. CONCLUSIONS: In this study of transmasculine and nonbinary adults, gender-affirming mastectomy was followed by substantial improvements in psychosocial functioning.

Enhanced Recovery after Surgery Protocol Decreases Length of Stay and Postoperative Narcotic Use in Microvascular Breast Reconstruction.

Background: Enhanced recovery after surgery (ERAS) protocols have demonstrated efficacy following microvascular breast reconstruction. This study assesses the impact of an ERAS protocol following microvascular breast reconstruction at a high-volume center. Methods: The ERAS protocol introduced preoperative counseling, multimodal analgesia, early diet resumption, and early mobilization to our microvascular breast reconstruction procedures. Data, including length of stay, body mass index, inpatient narcotic use, outpatient narcotic prescriptions, inpatient pain scores, and complications, were prospectively collected for all patients undergoing microvascular breast reconstruction between April 2019 and July 2021. Traditional pathway patients who underwent reconstruction immediately before ERAS implementation were retrospectively reviewed as controls. Results: The study included 200 patients, 99 in traditional versus 101 in ERAS. Groups were similar in body mass index, age (median age: traditional, 54.0 versus ERAS, 50.0) and bilateral reconstruction rates (59.6% versus 61.4%). ERAS patients had significantly shorter lengths of stay, with 96.0% being discharged by postoperative day (POD) 3, and 88.9% of the traditional cohort were discharged on POD 4 (P < 0.0001). Inpatient milligram morphine equivalents (MMEs) were smaller by 54.3% in the ERAS cohort (median MME: 154.2 versus 70.4, P < 0.0001). Additionally, ERAS patients were prescribed significantly fewer narcotics upon discharge (median MME: 337.5 versus 150.0, P < 0.0001). ERAS had a lower pain average on POD 0-3; however, this finding was not statistically significant. Conclusion: Implementing an ERAS protocol at a high-volume microvascular breast reconstruction center reduced length of stay and postoperative narcotic usage, without increasing pain or perioperative complications.

Health System Perspective on Cost for Delivering a Decision Aid for Prostate Cancer Using Time-driven Activity-based Costing.

BACKGROUND: Previsit decision aids (DAs) have promising outcomes in improving decisional quality, however, the cost to deploy a DA is not well defined, presenting a possible barrier to health system adoption. OBJECTIVES: We aimed to define the cost from a health system perspective of delivery of a DA. RESEARCH DESIGN: Observational cohort. PATIENTS AND METHODS: We interviewed or observed relevant personnel at 3 institutions with implemented DA distribution programs targeting men with prostate cancer. We then created process maps for DA delivery based on interview data. Cost determination was performed utilizing time-driven activity-based costing. Clinic visit length was measured on a subset of patients. Decisional quality measures were collected after the clinic visit. RESULTS: Total process time (minutes) for DA delivery was 10.14 (UCLA), 68 (Olive View-UCLA), and 25 (Vanderbilt). Total average costs (USD) per patient were $38.32 (UCLA), $59.96 (Olive View-UCLA), and $42.38 (Vanderbilt), respectively. Labor costs were the largest contributors to the cost of DA delivery. Variance analyses confirmed the cost efficiency of electronic health record (EHR) integration. We noted a shortening of clinic visit length when the DA was used, with high levels of decision quality. CONCLUSIONS: Time-driven activity-based costing is an effective approach to determining true inclusive costs of service delivery while also elucidating opportunities for cost containment. The absolute cost of delivering a DA to men with prostate cancer in various settings is much lower than the system costs of the treatments they consider. EHR integration streamlines DA delivery efficiency and results in substantial cost savings.

Cryotherapy for partial gland ablation of prostate cancer: Oncologic and safety outcomes.

BACKGROUND: Partial gland ablation (PGA) is a new option for treatment of prostate cancer (PCa). Cryotherapy, an early method of PGA, has had favorable evaluations, but few studies have employed a strict protocol using biopsy endpoints in men with clinically significant prostate cancer (csPCa). METHODS: 143 men with unilateral csPCa were enrolled in a prospective, observational trial of outpatient PGA-cryotherapy. Treatment was a 2-cycle freeze of the affected prostate part. Participants were evaluated with MRI-guided biopsy (MRGB) at baseline and at 6 months and 18 months after treatment. Absence of csPCa upon MRGB was the primary endpoint; quality-of-life at baseline and at 6 months after treatment was assessed by EPIC-CP questionnaires in the domains of urinary and sexual function. RESULTS: Of the 143 participants, 136 (95%) completed MRGB at 6 months after treatment. In 103/136 (76%), the biopsy revealed no csPCa. Of the 103, 71 subsequently had an 18-month comprehensive biopsy; of the 71 with 18-month biopsies, 46 (65%) were found to have no csPCa. MRI lesions became undetectable in 96/130 (74%); declines in median serum PSA levels (6.9 to 2.5 ng/mL), PSA density (0.15 to 0.07), and prostate volume (42 to 34cc) were observed (all p < 0.01). Neither lesion disappearance on MRI nor PSA decline correlated with biopsy outcome. Urinary function was affected only slightly and sexual function moderately. CONCLUSION: In the near to intermediate term, partial gland ablation with cryotherapy was found to be a safe and moderately effective treatment of intermediate-risk prostate cancer. Eradication of cancer was better determined by MRI-guided biopsy than by MRI or PSA.

Utility of Magnetic Resonance Imaging for Localizing Prostate Cancer Near the Urethra in Men Who Are Candidates for Focal Gland Ablation.

PURPOSE: Given that treatment near the urethra is often limited to reduce side effects, in this study we aim to determine whether prostate MRI can accurately identify the distance of prostate cancer to the urethra in a cohort of men who were potential candidates for focal gland ablation. MATERIALS AND METHODS: A single-institution analysis was performed of men who underwent MRI, targeted biopsy, and radical prostatectomy from July 2012 to April 2021. Men who were candidates for focal gland ablation were identified. The ability of MRI to identify prostate cancer within 5 mm of the prostatic urethra as confirmed on whole-mount pathology was assessed. Multivariate regression was utilized to determine characteristics associated with prostate cancer within 5 mm of the urethra on whole-mount pathology. RESULTS: In 48 out of 67 men (72%), the tumor was within 5 mm of the urethra on whole-mount pathology. MRI was concordant with whole-mount pathology in 49 out of 67 men (73%). The sensitivity of MRI for identifying cancer within 5 mm of the urethra was 77% (65%-89%) and the specificity was 63% (42%-89%). The positive predictive value was 84% (range 73%-95%) and negative predictive value was 52% (32%-73%). In adjusted analysis, PSA density and Prostate Imaging-Reporting and Data System were not significantly associated with having prostate cancer within close proximity of the urethra. CONCLUSIONS: A significant number of men who are potential candidates for focal gland ablation have cancer within close proximity to the urethra that could serve as a significant source of in-field recurrence. The sensitivity of MRI for identifying these lesions is 77% and can be used to further improve patient selection for focal gland ablation.

Impact of Comprehensive Health Insurance on Quality of Life in Low-Income Hispanic Men with Prostate Cancer.

OBJECTIVE: To evaluate the effect of the transition from IMPACT, a disease-focused treatment program, to comprehensive health insurance under Medicaid through the Affordable Care Act (ACA) on general and prostate cancer-specific quality of life (QoL) on a cohort of previously uninsured low-income men. We hypothesize that general QoL would improve and prostate cancer-specific QoL would remain the same after the transition to comprehensive health insurance. METHODS: We assessed and compared general QoL using the RAND SF-12v2™ (12-Item Short Form Survey, version 2) and prostate cancer-specific QoL using the UCLA PCI (Prostate Cancer Index) one year before, at, and one year after the transition between 30 men who transitioned to comprehensive insurance (newly insured/Medicaid group) and 54 men who remained in the prostate cancer program (uninsured/IMPACT group). We assessed the independent effects of Medicaid coverage on QoL outcomes using repeated-measures regression. RESULTS: Our cohort was composed primarily of Hispanic men (82%). At transition, patient demographics and clinical characteristics were similar between the groups. General and prostate cancer-specific QoL did not differ between the groups and remained stable over time, Radical prostatectomy as primary treatment and shorter time since treatment were associated with worse urinary and sexual function across both groups and over all three time points. CONCLUSION: Those who transitioned to full-scope insurance and those who remained in the free prostate cancer-focused treatment program had stable general and prostate cancer-specific QoL. High-touch navigation aspects of a disease-focused program may have contributed to stability in outcomes.

Intraoperative Laparoscopic Ultrasound Increases Fibroid Detection During Laparoscopic Myomectomy.

Objective: To assess the utility of intraoperative laparoscopic ultrasound in detecting additional fibroids during laparoscopic myomectomy (LM). Methods: Forty-two patients were enrolled in this prospective cohort study. All cases were performed by the same surgeon at a university affiliated hospital between April 1, 2019 and February 29, 2020. Following routine laparoscopic myomectomy, the laparoscopic ultrasound was then introduced, and ultrasonography was performed directly on the uterus. Any additional fibroids discovered were enucleated. Results: Using the laparoscopic ultrasound, an additional 54 fibroids among 27 (64%) of the 42 patients were found, with a median of 2 additional fibroids per patient (interquartile range [IQR] 1,3). Median fibroid size detected by laparoscopic ultrasound was 1.5 centimeters (IQR 1-3) and the most common types were FIGO grades 3 and 2 (43% and 33% respectively). The median surgical time was longer among patients in whom additional fibroids were found (170 minutes (IQR 137-219) vs 150 minutes (IQR 120-193), p = .044). When ≥ 2 fibroids were removed by usual methods, the laparoscopic ultrasound found additional fibroids 80% of the time, compared to 25% when < 2 fibroids were removed by usual methods (p < .001). Conclusion: Intraoperative laparoscopic ultrasonography is a useful tool in detecting additional fibroids that would have otherwise been missed. It is particularly helpful in identifying smaller intramural fibroids and in patients with multiple fibroids. By detecting additional fibroids, laparoscopic ultrasonography can help maximize the effectiveness of laparoscopic myomectomy and help decrease the rates of residual fibroids.

Comprehension, utility, and preferences of prostate cancer survivors for visual timelines of patient-reported outcomes co-designed for limited graph literacy: meters and emojis over comics.

OBJECTIVE: Visual timelines of patient-reported outcomes (PRO) can help prostate cancer survivors manage longitudinal data, compare with population averages, and consider future trajectories. PRO visualizations are most effective when designed with deliberate consideration of users. Yet, graph literacy is often overlooked as a design constraint, particularly when users with limited graph literacy are not engaged in their development. We conducted user testing to assess comprehension, utility, and preference of longitudinal PRO visualizations designed for prostate cancer survivors with limited literacy. MATERIALS AND METHODS: Building upon our prior work co-designing longitudinal PRO visualizations with survivors, we engaged 18 prostate cancer survivors in a user study to assess 4 prototypes: Meter, Words, Comic, and Emoji. During remote sessions, we collected data on prototype comprehension (gist and verbatim), utility, and preference. RESULTS: Participants were aged 61-77 (M = 69), of whom half were African American. The majority of participants had less than a college degree (95%), had inadequate health literacy (78%), and low graph literacy (89%). Among the 4 prototypes, Meter had the best gist comprehension and was preferred. Emoji was also preferred, had the highest verbatim comprehension, and highest rated utility, including helpfulness, confidence, and satisfaction. Meter and Words both rated mid-range for utility, and Words scored lower than Emoji and Meter for comprehension. Comic had the poorest comprehension, lowest utility, and was least preferred. DISCUSSION: Findings identify design considerations for PRO visualizations, contributing to the knowledge base for visualization best practices. We describe our process to meaningfully engage patients from diverse and hard-to-reach groups for remote user testing, an important endeavor for health equity in biomedical informatics. CONCLUSION: Graph literacy is an important design consideration for PRO visualizations. Biomedical informatics researchers should be intentional in understanding user needs by involving diverse and representative individuals during development.

Partial Gland Ablation of Prostate Cancer: Effects of Repeat Treatment.

OBJECTIVE: To evaluate the near-term clinical and pathological effects of repeat partial gland ablation (PGA) in men with intermediate-risk prostate cancer (PCa). MATERIALS AND METHODS: One hundred seventy men with focal lesions of PCa (all GG2 or GG3) underwent PGA with high-intensity focused ultrasound (HIFU) or cryotherapy (CRYO) in prospective trials. Residual PCa in or near the ablation zone was found in 37 men after a first PGA; 30 went on to receive a second PGA and were the subjects of study. At 3 timepoints, baseline and 6 months after first and second ablations, quality-of-life (QOL) questionnaires (IIEF, IPSS) and MRI-guided biopsies (MRGB) were performed. Biopsies were targeted and systematic at baseline and in follow-up, comprehensively about the ablation zone. RESULTS: All 30 patients completed QOL questionnaires and 26 had MRGB at the 3 timepoints. Mean QOL scores were not significantly different from the baseline after the first or second PGA. No operative complications were encountered; and "decisional regret" was reported in only 2/29 men after the repeat ablation. A decrease in semen volume was reported by 25% of patients. Repeat ablation was successful (absence of csPCa on MRGB) in 14/26 (53%) of men. PSA levels decreased and MRI lesions resolved after ablations, but neither was a reliable predictor of biopsy outcomes. CONCLUSION: When initial PGA fails, repeat PGA is a reasonable consideration, because in near-term follow-up, secondary procedures appear to be safe, causing only minimal detriment to urinary and sexual function, with csPCa becoming undetectable by MRGB in approximately half the patients.

Quality of life in low-income men after surgical castration for metastatic prostate cancer.

OBJECTIVE: To compare health-related quality of life in men who underwent surgical vs. medical castration for metastatic prostate cancer. METHODS: We analyzed data from a prospective cohort of men enrolled in a statewide public health program that provides care for prostate cancer among low-income, uninsured men from 2001 to 2020. Outcome measures included the RAND SF-12 and the UCLA Prostate Cancer Index (PCI) at baseline and every 6 months. We used generalized estimating equations to assess the independent impact of surgical vs. medical castration on health-related quality of life. RESULTS: Among men with metastatic prostate cancer, 27 underwent orchiectomy, and 274 underwent medical castration. Median cohort age at enrollment was 61.3 years (IQR 56-65); 239 (79%) men had less than a high school education. Average follow-up was 8 months (range 0-45) since study enrollment. Seventy percent of patients within the surgical castration group had their orchiectomy prior to study enrollment (median months since orchiectomy at study enrollment was 9 months, IQR 1-43). Similarly, 59% of patients within the medical castration group had begun ADT prior to study enrollment (median months since ADT initiation at study enrollment was 4 months, IQR 1-12). The majority (66%) had metastatic disease at diagnosis. The 2 groups did not differ in age, race/ethnicity, education, monthly income, baseline PSA, Gleason score, or percent metastatic at diagnosis. SF-12 domains did not differ between those who underwent surgical vs. medical castration (on average throughout follow-up, physical component difference -2.0, 95% CI -8.0-3.9 and mental component difference -1.0, 95% CI -5.4-+3.4). Patients treated with orchiectomy reported better urinary function than those who underwent medical castration (+16 point, 95%CI 5.3-26). CONCLUSIONS: Surgical castration did not negatively impact general or disease-specific quality of life. The finding of improved urination after orchiectomy merits further inquiry. This may inform urologists' discussion of surgical vs. medical options for men with castration-sensitive metastatic prostate cancer.

Targeted Prostate Biopsy: Umbra, Penumbra, and Value of Perilesional Sampling.

BACKGROUND: Systematic prostate biopsies add to the cancer detection rate of targeted biopsies, but the explanation for that increased sensitivity is not yet clear. OBJECTIVE: To determine and quantify the utility of perilesional biopsies in the detection of clinically significant prostate cancer (csPCa). DESIGN, SETTING, AND PARTICIPANTS: Participants were 2048 men with magnetic resonance imaging (MRI) lesions (grades 3-5) who underwent targeted and systematic prostate biopsy via MRI/ultrasound fusion at University of California Los Angeles and Cornell between 2011 and 2019. The study is a retrospective examination of prospectively acquired data. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: All biopsy cores (30191), locations of which had been stored digitally in the image-fusion device, were analyzed for tissue pathology and relationship with MRI lesions. A validated Matlab script was used to determine the distance between MRI lesions and cores containing csPCa (3552 cores from 927 men). Significance of distance measurements was determined by multilevel, multivariable logistic regression to account for within patient-biopsy correlation and control for patient characteristics. RESULTS AND LIMITATIONS: Overall, 90% (95% confidence interval [CI] = 89-91) of csPCa cores (3206/3552) were located within a radius of 10 mm from the nearest lesion: 65% (95% CI = 63-67) within the region of interest (ROI) and 26% (95% CI = 24-27) outside the ROI but within the 10-mm "penumbra." The width of the penumbra or concentric band, which enclosed 90% of csPCa, was primarily related to MRI grade of lesion: grade 5, 5 mm; grade 4, 12 mm; grade 3, 16 mm. In 18% (95% CI = 15-20) of patients (166/927), csPCa was diagnosed only by sampling outside the MRI lesion, the yield decreasing with increasing distance. Limitations of MRI interpretation and fusion biopsy performance could affect the utility of these data in individual patients. CONCLUSIONS: Perilesional biopsies, that is, samples taken from a band of 10-mm radius outside MRI lesions (the penumbra), contain most cores of csPCa that are not present within the lesion. These data may help increase the performance characteristics of targeted prostate biopsy. PATIENT SUMMARY: We studied the locations of cancer within the prostate in men undergoing magnetic resonance imaging (MRI)-guided biopsy. We found that not all cancers are located within the MRI lesion, but 90% (95% confidence interval = 89-91) of the cancers arewithin 1 cm of the lesions. Biopsies taken from both within and around MRI lesions provide greater sensitivity for cancer detection than samples taken from the lesion only.

Magnetic Resonance Imaging-Guided Biopsy in Active Surveillance of Prostate Cancer.

PURPOSE: The underlying premise of prostate cancer active surveillance (AS) is that cancers likely to metastasize will be recognized and eliminated before cancer-related disease can ensue. Our study was designed to determine the prostate cancer upgrading rate when biopsy guided by magnetic resonance imaging (MRGBx) is used before entry and during AS. MATERIALS AND METHODS: The cohort included 519 men with low- or intermediate-risk prostate cancer who enrolled in prospective studies (NCT00949819 and NCT00102544) between February 2008 and February 2020. Subjects were preliminarily diagnosed with Gleason Grade Group (GG) 1 cancer; AS began when subsequent MRGBx confirmed GG1 or GG2. Participants underwent confirmatory MRGBx (targeted and systematic) followed by surveillance MRGBx approximately every 12 to 24 months. The primary outcome was tumor upgrading to ≥GG3. RESULTS: Upgrading to ≥GG3 was found in 92 men after a median followup of 4.8 years (IQR 3.1-6.5) after confirmatory MRGBx. Upgrade-free probability after 5 years was 0.85 (95% CI 0.81-0.88). Cancer detected in a magnetic resonance imaging lesion at confirmatory MRGBx increased risk of subsequent upgrading during AS (HR 2.8; 95% CI 1.3-6.0), as did presence of GG2 (HR 2.9; 95% CI 1.1-8.2) In men who upgraded ≥GG3 during AS, upgrading was detected by targeted cores only in 27%, systematic cores only in 25% and both in 47%. In 63 men undergoing prostatectomy, upgrading from MRGBx was found in only 5 (8%). CONCLUSIONS: When AS begins and follows with MRGBx (targeted and systematic), upgrading rate (≥GG3) is greater when tumor is initially present within a magnetic resonance imaging lesion or when pathology is GG2 than when these features are absent.

The impact of state legalization on rates of marijuana use in pregnancy in a universal drug screening population.

OBJECTIVE: To evaluate the effect of state legalization of rate on marijuana use in pregnancy in a population with universal drug screening. METHODS: This is a retrospective cohort study from July 2016 to December 2018 of pregnant women who had universal drug screening of marijuana use before and after legalization of recreational marijuana in California on 1 January 2018. Maternal medical conditions and neonatal outcomes associated with usage were also evaluated. Student's t-test, Wilcoxon rank-sum test, and multiple linear regression were used for statistical analyses. RESULTS: Of 466 women, initial marijuana usage in pregnancy confirmed by urine drug test increased after legalization from 6 to 11% (p = .05). Factors associated with marijuana usage included younger age, white or black race, single marital status, psychiatric disorders, intimate partner violence and concomitant tobacco and alcohol use. 73% of users in this study had cessation of marijuana use with subsequent negative UDT. There was no statistical difference in rates of preterm birth, small for gestational age, NICU admission, or Apgar scores, when adjusted for other risk factors. CONCLUSION: Rates of marijuana usage in pregnant women who underwent universal drug screening increased after legalization. There were no differences in neonatal outcomes between users and non-users.

A prostate cancer risk calculator: Use of clinical and magnetic resonance imaging data to predict biopsy outcome in North American men.

INTRODUCTION: A functional tool to optimize patient selection for magnetic resonance imaging (MRI)-guided prostate biopsy (MRGB) is an unmet clinical need. We sought to develop a prostate cancer risk calculator (PCRC-MRI) that combines MRI and clinical characteristics to aid decision-making for MRGB in North American men. METHODS: Two prospective registries containing 2354 consecutive men undergoing MRGB (September 2009 to April 2019) were analyzed. Patients were randomized into five groups, with one group randomly assigned to be the validation cohort against the other four groups as the discovery cohort. The primary outcome was detection of clinically significant prostate cancer (csPCa) defined as Gleason grade group ≥2. Variables included age, ethnicity, digital rectal exam (DRE), prior biopsy, prostate-specific antigen (PSA), prostate volume, PSA density, and MRI score. Odds ratios (OR) were calculated from multivariate logistic regression comparing two models: one with clinical variables only (clinical) against a second combining clinical variables with MRI data (clinical+MRI). RESULTS: csPCa was present in 942 (40%) of the 2354 men available for study. The positive and negative predictive values for csPCa in the clinical+MRI model were 57% and 89%, respectively. The area under the curve of the clinical+MRI model was superior to the clinical model in discovery (0.843 vs. 0.707, p<0.0001) and validation (0.888 vs. 0.757, p<0.0001) cohorts. Use of PCRC-MRI would have avoided approximately 16 unnecessary biopsies in every 100 men. Of all variables examined, Asian ethnicity was the most protective factor (OR 0.46, 0.29-0.75) while MRI score 5 indicated greatest risk (OR15.8, 10.5-23.9). CONCLUSIONS: A risk calculator (PCRC-MRI), based on a large North American cohort, is shown to improve patient selection for MRGB, especially in preventing unnecessary biopsies. This tool is available at https://www.uclahealth.org/urology/prostate-cancer-riskcalculator and may help rationalize biopsy decision-making.

Comparison of Pelvic Floor Physical Therapy Attendance Based on Referring Provider Specialty.

OBJECTIVE: The objective of this study was to determine whether pelvic floor physical therapy (PFPT) attendance differs based on referring provider specialty and identify factors related to PFPT initiation and completion. METHODS: This was an institutional review board-approved retrospective cohort study examining referrals from female pelvic medicine and reconstructive surgery (FPMRS) and non-FPMRS providers at a single academic medical center to affiliated PFPT clinics over a 12-month period. Demographics, referring specialty and diagnoses, prior treatment, and details regarding PFPT attendance were collected. Characteristics between FPMRS and non-FPMRS referrals were compared and multivariate logistic regression analyses were performed to identify factors associated with PFPT initiation and completion. RESULTS: A total of 497 referrals were placed for PFPT. Compared with non-FPMRS referrals, FPMRS referrals were for patients who were older (54.7 years vs 35.6 years), and had higher parity; more were postmenopausal (56% vs 18%) and had Medicare insurance (22% vs 10%) (all P < 0.001). Most FPMRS referrals were for patients with urinary incontinence (69% vs 31%), whereas non-FPMRS referrals were for patients with pelvic pain (70% vs 27%) (both P < 0.0001). Pelvic floor physical therapy attendance was similar in both groups when comparing rates of initiation (47% vs 45%) and completion (13% vs 16%). In multivariate analysis, factors associated with initiation were age 65 years or older, additional therapy provided at referring visit, private insurance, Asian race, pregnant or postpartum at time of referral, and more than 1 referring diagnosis (all P < 0.05). No factors were associated with completion. CONCLUSIONS: Less than half of the patients referred to PFPT initiate therapy, and only 15% complete PFPT. The populations referred by FPMRS and non-FPMRS providers are different, but ultimately PFPT utilization is similar.