Expanded Prostate Cancer Index Composite Scores Research Articles

Physiotherapy for continence and muscle function in prostatectomy: a randomised controlled trial.

To assess the effectiveness of pre- and postoperative supervised pelvic floor muscle training (PFMT) on the recovery of continence and pelvic floor muscle (PFM) function after robot-assisted laparoscopic radical prostatectomy (RARP). We carried out a single-blind randomised controlled trial involving 54 male patients scheduled to undergo RARP. The intervention group started supervised PFMT 2 months before RARP and continued for 12 months after surgery with a physiotherapist. The control group was given verbal instructions, a brochure about PFMT, and lifestyle advice. The primary outcome was 24-h pad weight (g) at 3 months after RARP. The secondary outcomes were continence status (assessed by pad use), PFM function, and the Expanded Prostate Cancer Index Composite (EPIC) score. Patients who participated in supervised PFMT showed significantly improved postoperative urinary incontinence (UI) compared with the control group (5.0 [0.0-908.0] g vs 21.0 [0.0-750.0] g; effect size: 0.34, P = 0.022) at 3 months after RARP based on 24-h pad weight. A significant improvement was seen in the intervention compared with the control group (65.2% continence [no pad use] vs 31.6% continence, respectively) at 12 months after surgery (effect size: 0.34, P = 0.030). Peak pressure during a maximum voluntary contraction was higher in the intervention group immediately after catheter removal and at 6 months, and a longer duration of sustained contraction was found in the intervention group compared with the control group. We were unable to demonstrate a difference between groups in EPIC scores. Supervised PFMT can improve postoperative UI and PFM function after RARP. Further studies are needed to confirm whether intra-anal pressure reflects PFM function and affects continence status in UI in men who have undergone RARP.

One-year clinical outcomes of MR-guided stereotactic body radiation therapy with rectal spacer for patients with localized prostate cancer

Background and purposeThis prospective study aimed to investigate adaptive magnetic resonance (MR)-guided stereotactic body radiation therapy (MRgSBRT) with rectal spacer for localized prostate cancer (PC) and report 1-year clinical outcomes.Materials and methodsThirty-four consecutive patients with low- to high-risk localized PC that underwent 5-fraction adaptive MRgSBRT with rectal spacer were enrolled. The dosimetric comparison was performed on a risk- and age-matched cohort treated with MRgSBRT but without a spacer at a similar timepoint. Clinician-reported outcomes were based on Common Terminology Criteria for Adverse Events. Patient-reported outcomes were based on the Expanded Prostate Cancer Index Composite (EPIC) questionnaire at baseline, acute (1–3 months), subacute (4–12 months), and late (> 12 months) phases.ResultsThe median follow-up was 390 days (range 28–823) and the median age was 70 years (range 58–82). One patient experienced rectal bleeding soon after spacer insertion that subsided before MRgSBRT. The median distance between the midline of the prostate midgland and the rectum after spacer insertion measured 7.8 mm (range 2.6–15.3), and the median length of the spacer was 45.9 mm (range 16.8–62.9) based on T2-weighted MR imaging. The use of spacer resulted in significant improvements in target coverage (V100% > 95% = 98.6% [range 93.4–99.8] for spacer vs. 97.8% [range 69.6–99.7] for non-spacer) and rectal sparing (V95% < 3 cc = 0.7 cc [range 0–4.6] for spacer vs. 4.9 cc [range 0–12.5] for non-spacer). Nine patients (26.5%) experienced grade 1 gastrointestinal toxicities, and no grade ≥ 2 toxicities were observed. During the 1-year follow-up period, EPIC scores for the bowel domain remained stable and were the highest among all other domains.ConclusionsMRgSBRT with rectal spacer for localized PC showed exceptional tolerability with minimal gastrointestinal toxicities and satisfactory patient-reported outcomes. Improvements in dosimetry, rectal sparing, and target coverage were achieved with a rectal spacer. Randomized trials are warranted for further validation.

Prospective Validation of Single Nucleotide Polymorphisms as Predictors of Gastrointestinal, Genitourinary, and Sexual Patient-Reported Outcomes Following Radiotherapy for Prostate Cancer.

Radiotherapy (RT) for localized prostate cancer (PC) can adversely impact gastrointestinal (GI), genitourinary (GU), and sexual quality of life (QoL). Biomarkers are needed to accurately predict individualized risk of toxicity and enable tailoring of therapy. Single nucleotide polymorphisms (SNPs) have been reported as potential predictors of RT-related toxicities, but have not been associated with patient-report outcomes (PRO) in prospective cohorts. In this study, we sought to validate these SNPs in a prospective registry study of RT for PC, with high-quality prospectively collected PRO data. Men with low/intermediate risk PC were consented to a multicenter companion registry study associated with the PARTIQoL Phase III Randomized Trial of proton vs. photon RT. Patients received RT to prostate/seminal vesicles per protocol. Androgen deprivation therapy and pelvic lymph node RT were not allowed. 95 patients enrolled between 2014-2020 at a single institution had blood specimens available for germline DNA analysis. 172 SNPs previously reported to correlate with GI, GU, and/or sexual RT toxicities were genotyped. PRO data through the Expanded Prostate Cancer Index Composite (EPIC) were collected prior to RT and at prespecified follow-up (FU) time points. Change of the EPIC score from baseline was compared between genotypes of previously identified SNPs using a two-sample t-test. Significant clinically meaningful QoL differences were identified by an effect size of at least 0.4σ with two-sided p<0.05, where σ represents the standard deviation of the score change. Median FU was 39 months (r, 6-89). Median age was 68 years (r, 52-83). Features at diagnosis include: 77% T1c, median PSA 5.8 (r, 1.43-15.1), 53% Gleason 7, median prostate volume 45.5cc (r, 16-142). 43% received proton RT; 53% had a rectal spacer. 40% received 79.2 Gy/44 fractions; 60% received 70 Gy/28 fractions. Between 6 to 24 months post-RT, there were 19 SNPs that were significantly associated with clinically meaningful decreases in GI QoL scores, 19 that were significantly associated with clinically meaningful decreases in GU QoL scores, and 10 SNPs that were significantly associated with clinically meaningful decreases in sexual QoL scores. Three BRCA2 SNPs (rs1801439, rs1801499, rs1799944) were significantly associated with clinically meaningful decreases in both GI and GU QoL scores. Of the 172 SNPs previously reported to be associated with GI, GU, and/or sexual toxicity after prostate RT, 23% were validated for domain-specific QoL detriment. Ongoing analyses include integrated modeling of dosimetry and SNP data for prediction of toxicities and PRO, and evaluation of potential interactions between RT modality (proton/photon) and QoL-associated SNPs.

Long-Term Urinary Toxicity Follow-Up of Combined External Beam Radiation and Cs-131 LDR Brachytherapy Boost for Prostate Cancer

To evaluate and update our institutional data on chronic patient-reported urinary symptoms in patients with prostate cancer treated with combined external beam radiation therapy (EBRT) and Cesium-131 (Cs-131) LDR brachytherapy boost. Patients treated from September 2006-July 2022 and with at least 6 months of follow-up were analyzed. Patients filled out the Expanded Prostate Cancer Index Composite (EPIC) questionnaire pre-treatment and at each scheduled follow-up. Mean EPIC urinary scores were calculated for urinary summary, urinary function, urinary bother, urinary incontinence, and urinary irritative/obstructive domains. Changes of 7-points or more in mean domain scores were deemed clinically significant. The prevalence of urinary bleeding was calculated and bleeding occurring more than "about once a week" ("more than once a week", "about once a day", and "more than once a day") was deemed clinically significant. Outcomes were analyzed at each follow-up timepoint using paired t-test. A total of 341 patients with prostate cancer were included in the analysis of which 183 were intermediate-risk and 158 high-risk. 174 patients were treated with tri-modality therapy, and SpaceOAR was used in 108 patients. Long-term statistically significant decreases in mean EPIC QOL scores were seen in urinary summary, urinary function, urinary bother, urinary incontinence, and urinary irritative/obstructive domains at 6 months, with clinically and statistically significant decreases in urinary function and urinary incontinence at 6 months (86±17.4, 83.4±22.2 respectively) and up to 18 months post-treatment (84.8±17.4, 83.6±20.7 respectively) compared with pre-treatment scores (93.1±10.7, 90.8±14.8 respectively), with both domains returning to clinical baseline at 24 months. Urinary irritative/obstructive mean scores clinically and significantly decreased at 9 months (77±17.4) compared to pre-treatment (84.7±13.5), returning to clinical baseline at 12 months. The prevalence of clinically significant urinary bleeding at 6, 12, 24, 36, 48, and 60 months was 1.3%, 2.6%, 3.7%, 0.7%, 0.9%, and 2.3% respectively. At the median follow-up of 42 months (IQR 54, 18-72), mean EPIC scores were clinically improved (≥7-point increase) from pre-treatment baseline in 15-30% of patients across the analyzed urinary domains. Long-term patient-reported clinically significant decreases in urinary function and urinary incontinence mean EPIC scores occurred up to 18 months following combined external beam radiation and Cs-131 prostate brachytherapy and returned to baseline at 24 months, while clinically significant decrease in urinary irritability/obstructive mean scores occurred at 9 months and returned to baseline at 12 months. At 42 months follow-up, mean urinary domain scores improved from pre-treatment baseline in 15-30% of patients.

Dose-Volume Histogram Parameters and Quality of Life in Patients with Prostate Cancer Treated with Surgery and High-Dose Volumetric-Intensity-Modulated Arc Therapy to the Prostate Bed.

Prostate bed radiotherapy (RT) is a major affecter of patients' long-term quality of life (QoL). To ensure the best possible outcome of these patients, dose constraints are key for optimal RT planning and delivery. However, establishing refined dose constraints requires access to patient-level data. Therefore, we aimed to provide such data on the relationship between OAR and gastrointestinal (GI) as well as genitourinary (GU) QoL outcomes of a homogenous patient cohort who received dose-intensified post-operative RT to the prostate bed. Furthermore, we aimed to conduct an exploratory analysis of the resulting data. Patients who were treated with prostate bed RT between 2010 and 2020 were inquired about their QoL based on the Expanded Prostate Cancer Index Composite (EPIC). Those (n = 99) who received volumetric arc therapy (VMAT) of at least 70 Gy to the prostate bed were included. Dose-volume histogram (DVH) parameters were gathered and correlated with the EPIC scores. The median age at the time of prostate bed RT was 68.9 years, and patients were inquired about their QoL in the median 2.3 years after RT. The median pre-RT prostate-specific antigen (PSA) serum level was 0.35 ng/mL. The median duration between surgery and RT was 1.5 years. The median prescribed dose to the prostate bed was 72 Gy. A total of 61.6% received prostate bed RT only. For the bladder, the highest level of statistical correlation (p < 0.01) was seen for V10-20Gy, Dmean and Dmedian with urinary QoL. For bladder wall, the highest level of statistically significant correlation (p < 0.01) was seen for V5-25Gy, Dmean and Dmedian with urinary QoL. Penile bulb V70Gy was statistically significantly correlated with sexual QoL (p < 0.05). A larger rectal volume was significantly correlated with improved bowel QoL (p < 0.05). Sigmoid and urethral DVH parameters as well as the surgical approach were not statistically significantly correlated with QoL. Specific dose constraints for bladder volumes receiving low doses seem desirable for the further optimization of prostate bed RT. This may be particularly relevant in the context of the aspiration of establishing focal RT of prostate cancer and its local recurrences. Our comprehensive dataset may aid future researchers in achieving these goals.

Patient-reported outcomes after robot-assisted radical prostatectomy and institutional learning curve for functional outcomes

The study was performed to examine patient-reported outcomes (PROs) in the 1st year after surgery and the institutional learning curve after the introduction of robot-assisted radical prostatectomy (RARP). The subjects were 320 consecutive patients who underwent RARP from 2014 to 2018. These cases were divided into three groups treated in the early, middle, and late periods, with about 100 cases in each. PROs were recorded using the Expanded Prostate Cancer Index Composite (EPIC). There were no significant differences among the early, middle, and late periods based on EPIC scores. Urinary function and bother decreased in the 1st month after surgery, and gradually recovered thereafter. However, urinary function was significantly worse in the 1st year after surgery than at baseline. Urinary function and bother were better in patients treated with nerve-sparing surgery, and in nerve-sparing cases, urinary function and bother were best in the early period and worst in the late period. These cases also had the best score for sexual function in the early period, but sexual bother was worst in the early period. In contrast, in cases treated without nerve-sparing surgery, urinary function and bother were best in the late period and worst in the early period, although without significant differences. The functional results of this study based on PROs are useful for providing information for patients. Interestingly, the institutional learning curves for RARP differed in cases that did and did not undergo a nerve-sparing procedure.

PL04 Presentation Time: 2:45 PM: A Randomized Phase III Trial Comparing Health-Related Quality of Life After Low Dose Rate or High Dose Rate Prostate Brachytherapy Boost Combined with External Beam Pelvic Radiotherapy

<h3>Purpose</h3> This randomized phase III trial compared health related quality of life (HRQOL) in urinary, bowel, and sexual domains in men with intermediate (IR) and high-risk (HR) prostate cancer treated with combined external beam radiation therapy (EBRT) and prostate brachytherapy (BT) using either low dose rate (LDR) or high dose rate (HDR). <h3>Materials and Methods</h3> Eligible men receiving pelvic EBRT (46 Gy/23F) combined with prostate BT were randomized to either an LDR (110 Gy) or HDR (15 Gy) boost. HDRBT preceded EBRT by 1 week while LDRBT followed. Time 0 for QOL evaluations was day 1 of any radiotherapy. The Expanded Prostate Cancer Index Composite (EPIC) questionnaire was used to evaluate HRQOL q3 months for the first year, q6 months to 3 years and then annually. The Mann-Whitney U test was used to compare mean EPIC scores for urinary, bowel and sexual summary domains. <h3>Results</h3> From 01/2014 to 01/2020, 191 men were randomized: 42% IR and 58% HR. Median age was 71 years. T stage was T1c/T2a:34%, T2b:28%, T2c:24% and T3:13%. 57% had Gleason 7, 13% Gleason 8 and 30% Gleason 9. 74% received ADT with at least 3 months neoadjuvant and for a median duration of 12 mo. Median follow-up was 48 mo. HDR patients had higher (better) HRQOL urinary domain scores at 3 mo. (79.0 vs. 69.4; p<.001) and 6 mo. (84.0 vs. 76.9; p<.001), and higher bowel domain scores at 3 mo. (87.0 vs. 82.1; p=.005) and 6 mo. (88.7 vs. 82.8; p=.023). Better bowel domain scores were sustained at 24, 36, and 48 mo. In contrast, HDR patients had worse HRQOL urinary domain scores at 1 mo. (73.6 vs. 80.7; p=.003). There was no statistically significant difference in HRQOL sexual domain scores between the two arms. <h3>Conclusions</h3> The effect of HDRBT on urinary and bowel domains was evident 1 mo. post implant but had recovered at 3 and 6 mo., while LDR patients were still experiencing significant QOL impact of their ongoing LDRBT. Although HDR patients sustained an advantage in long term bowel function compared to LDR, there was no difference in long term urinary QOL between the 2 types of BT after the acute phase subsided. The patient treatment experience of combined EBRT/BT is improved with HDR. Efficacy will be reported at 5 year minimum follow up.

An observational study evaluating the impact on prostate patient outcomes and experiences when radiation therapists use a standard grading system tool to assess and document treatment-related toxicities and interventions

Background/PurposeMen undergoing radiation therapy (RT) treatment for prostate cancer (PC) often experience acute urinary, bowel, sexual, and hormonal toxicities. Timely screening, management, and documentation of these toxicities is an integral part of clinician practice, ensuring patients receive the care they require. Various screening tools, completed by either the patient or the clinician, are available, which allow clinicians to collect and respond to these toxicity outcomes; however there is a paucity of literature regarding the effective use and timing of these tools during RT treatment. This study aims to evaluate the feasibility of conducting comprehensive toxicity screening and symptom management using a toxicity screening tool in one of the busiest RT departments in Canada. Specifically, the use of a toxicity screening tool and its effect on the quality of toxicity documentation, operational impact, and patient reported outcomes (PRO). Methods90 consented patients were allocated to either the structured or non-structured arm. Patients in the structured arm were assessed weekly by radiation therapists for 13 toxicities across four domains (bladder, bowel, hormonal, and sexual), using an in-house developed structured questionnaire, known as the Grid, to complete the National Cancer Institute's Common Toxicity Criteria for Adverse Events v3 (CTCAEv3). Patients in the non-structured arm were assessed and had free text clinical documentation charted according to current department policy. The Expanded Prostate Cancer Index Composite (EPIC), a PRO tool to evaluate patient function and bother after prostate cancer treatment, was completed by all study patients on a weekly basis. Statistical analysis compared documentation completeness, EPIC scores, patient satisfaction, and operational impact between study arms, as well as evaluated optimal timing of toxicity assessments. ResultsAssessment of the non-structured arm for completeness revealed an inconsistent and insufficient amount of documentation for the bladder and bowel domains. As for both the sexual and hormonal domains, documentation was largely absent. There was no difference in EPIC scores and patient satisfaction scores between the structured arm and the non-structured arm. Evaluation of the timing of PROs showed significant week to week change for the bladder and bowel toxicities, but not the sexual and hormonal toxicities. Finally, the use of the Grid revealed no significant impact on daily operations, only increasing average treatment times by seven seconds, and did not create any additional workload for the oncologists. ConclusionsUse of the Grid increased documentation completeness without negatively impacting clinical flow or operations, despite the fact that PROs were not improved. Based on EPIC PRO scores, bladder and bowel toxicities should be evaluated on a weekly basis during RT treatment, while sexual and hormonal toxicities need only be evaluated monthly.

The cost of elective nodal coverage in prostate cancer: Late quality of life outcomes and dosimetric analysis with 0, 45 or 54 Gy to the pelvis

PurposeElective pelvic lymph node radiotherapy (PLNRT) in prostate cancer is often omitted from definitive (n = 267) and post prostatectomy (n = 160) radiotherapy (RT) due to concerns regarding toxicity and efficacy. Data comparing patient-reported outcome measures (PROMs) with or without PLNRT is limited. Our long-term supposition is that PLNRT, particularly to higher doses afforded by IMRT, will decrease pelvic failure rate in select patients. We aim to establish the impact of two different PLNRT doses on long term quality of life (QOL). Methods and materialsProstate cancer patients (n = 428) recorded baseline scores using the Expanded Prostate Cancer Index Composite (EPIC), prior to definitive or post-prostatectomy RT. PLNRT, if given, was prescribed to 45 or 54 Gy at 1.8 Gy per fraction. New EPIC scores were recorded 20–36 months after radiotherapy. Absolute change in each domain subscale and summary score was recorded, along with if these changes met minimally important difference (MID) criteria. A separate multivariate analysis (MVA) was performed for each measure. Subsequent dosimetric analysis was performed. ResultsFrequency of a MID decline was significantly greater with PLNRT to 54 Gy for urinary function, incontinence, and overall. No urinary decline was correlated with PLNRT to 45 Gy. PLNRT to 54 Gy was significant for decline in urinary function, bother, irritative, incontinence, and overall score in one or both MVA models while 45 Gy was not. Postoperative status was significant for decline in urinary function, incontinence, and overall. Amongst postoperative patients, there was significantly greater decline in urinary function score in the salvage setting. Neither 54 nor 45 Gy significantly affected bowel subscale or overall score decline. ConclusionsUsing conventional fractionation, adding PLNRT to 54 Gy, but not 45 Gy, correlates with worse urinary QOL, with postoperative patients experiencing a steeper decline. PLNRT had no significant impact on bowel QOL with either dose.

Using customized PRO profiles to evaluate expected patient quality-of-life outcomes.

e18607 Background: Patient Reported Outcomes (PROs) are routinely employed in patient-focused drug development programs. However, PRO data are often under-utilized. Better approaches could employ trial data to describe expected patient outcomes. The objective of this work was to present a method for leveraging PRO-based patient profiles to project and thereby anticipate expected patient outcomes. Methods: A model-based approach to analyzing PRO scores allows for a more tailored approach to evaluating outcomes of interest. To demonstrate this approach, we analyzed PRO data from a Phase 3 trial of patients with prostate cancer randomized to either Hypofractionated 3D-CRT/MRT (experimental arm) or Conventionally Fractionated 3D-CRT/MRT (comparator arm). The outcome of interest was the difference between treatment arms on the Expanded Prostate cancer Index Composite (EPIC) urinary domain scores, defined on the sum of responses to 12 items. A longitudinal regression model was fit to EPIC scores at 6, 12, 24, and 60 months post-baseline. Patient profile variables (baseline EPIC urinary scores, treatment arm, age, race, clinical T-stage, and Gleason score) were included as predictors. For a particular patient profile of interest, expected EPIC urinary score at 6 months was estimated, as well as associated 95% confidence intervals, which allowed for an understanding of the range of likely outcomes for that particular patient profile. Results: n = 550 patients in the experimental arm and n = 542 patients in the comparator were analyzed. The difference in EPIC urinary scores between treatment arms at 6 and 12 months were computed, with higher scores reflecting greater symptom severity. The model estimated a difference of 2.12 points (p = 0.009) at 6 months and 2.16 points (p = 0.013) at 12 months, favoring the experimental arm. To illustrate how customized patient profiles can be used to better understand patient outcomes, a single profile is presented. At baseline, a patient receiving the experimental treatment, EPIC urinary score 98.0, age 57, white, clinical T-stage T2, Gleason score 6, could be expected to report an EPIC urinary score of 94.3 (92.06, 96.00) at 6 months based on the statistical model. In the observed trial data, one patient with this profile reported an EPIC urinary score of 93.8 at 6 months. The expected EPIC urinary score overestimated the observed score by only 0.53%, indicating the accuracy of the expected EPIC urinary scores. This corresponds to approximately one category decrease on two of the 12 domain items (i.e., a decrease in symptom severity). Conclusions: Well-established statistical methods can lead to improved clinician understanding of expected outcomes specific to a given patient profile. This would facilitate communication between clinician and patient regarding anticipated oncology treatment outcomes. Recommendations to support the use of these methods should be considered.

A phase II trial of stereotactic body radiotherapy in 4 fractions for patients with localized prostate cancer

Purpose/objective(s)To report results from our phase II study of stereotactic body radiotherapy (SBRT) delivering 36 Gy in 4 fractions for patients with localized prostate cancer.Materials/methodsWe enrolled 55 patients treated with SBRT delivering 36 Gy in 4 fractions between 2015 to 2018. All patients were categorized as low-risk (n = 4), intermediate-risk (n = 31) or high-risk (n = 20) according to National Comprehensive Cancer Network criteria. Median age was 73 years (range 54–86 years). Two-thirds of patients (n = 37) had received androgen-deprivation therapy for 3–46 months (median, 31 months). Median duration of follow-up was 36 months (range 1–54 months). We used Radiation Therapy Oncology Group and National Cancer Institute—Common Toxicity Criteria version 4 for toxicity assessments. Quality of life (QOL) outcomes were also evaluated using the Expanded Prostate Cancer Index Composite (EPIC).ResultsProtocol treatments were completed for all patients. Six patients experienced biochemical failures. Among these six patients, three patients experienced clinical failure. One patient showed bone metastasis before biochemical failure. One patient died of gastric cancer. The 3-year biochemical control rate was 89.8%. Acute grade 2 genitourinary (GU) and gastrointestinal (GI) toxicities were observed in 5 patients (9%) and 6 patients (11%), respectively. No grade 3 or higher acute toxicities were observed. Late grade 2 GU and GI toxicities were observed in 7 patients (13%) and 4 patients (7%), respectively. Late grade 3 GU and GI toxicities were observed in 1 patient (1.8%) each. EPIC scores decreased slightly during the acute phase and recovered within 3 months after treatment.ConclusionOur phase II study showed that SBRT delivering 36 Gy in 4 fractions was safe and effective with favorable QOL outcomes, although this regimen showed slightly more severe toxicities compared to current standards.

MP23-18 ASSESSING THE IMPACT OF DECISION AID USE ON POST PROSTATECTOMY PATIENT REPORTED OUTCOMES

You have accessJournal of UrologyHealth Services Research: Practice Patterns, Quality of Life and Shared Decision Making III (MP23)1 Sep 2021MP23-18 ASSESSING THE IMPACT OF DECISION AID USE ON POST PROSTATECTOMY PATIENT REPORTED OUTCOMES Giulia I. Lane, Ji Qi, Stephanie Ferrante, Roshan Paudel, Daniela Wittmann, Lauren Wallner, Chad Ellimoottil, James Montie, J. Quentin Clemens, and for the Michigan Urological Surgery Improvement Collaborative Giulia I. LaneGiulia I. Lane More articles by this author , Ji QiJi Qi More articles by this author , Stephanie FerranteStephanie Ferrante More articles by this author , Roshan PaudelRoshan Paudel More articles by this author , Daniela WittmannDaniela Wittmann More articles by this author , Lauren WallnerLauren Wallner More articles by this author , Chad EllimoottilChad Ellimoottil More articles by this author , James MontieJames Montie More articles by this author , J. Quentin ClemensJ. Quentin Clemens More articles by this author , and for the Michigan Urological Surgery Improvement Collaborative More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002014.18AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The association between decision aids (DA) use and clinically-meaningful patient reported outcomes is not well established. We evaluated whether completing a DA, Personalized Patient Profile – Prostate (P3P), prior to prostatectomy, affects self-reported bother associated with post-prostatectomy urinary incontinence (UI) and erectile dysfunction (ED). METHODS: Patients with newly diagnosed clinically localized, very low to intermediate risk prostate cancer within the Michigan Urological Surgery Improvement Collaborate (MUSIC) between 2018-20 who elected prostatectomy treatment were included. The primary outcomes were patient-reported bother from UI and ED, measured by the Expanded Prostate Cancer Index Composite (EPIC). We used multivariable logistic regression to estimate the association between P3P use and bother from post prostatectomy ED and UI, adjusting for age, race, ethnicity, family history of prostate cancer, Gleason score, stage, PSA, urologist and ED and UI before surgery and at follow-up. RESULTS: Among 3651 men, the mean age was 63 (SD 7), the majority were Caucasian (74%) with Gleason 7 (84%), T1a-c disease (80%) and median PSA of 6 (IQR 5, 8). At baseline, 6.3% completed P3P. At 3, 6, and 12 months postoperatively, EPIC scores were available for 51%, 39% and 23% of P3P completers and 51%, 43% and 28% non-completers.Men who completed P3P reported less bother from the same levels of ED at 6 months vs non-completers (aOR 0.45 [95% CI 0.27-0.73]). (Fig 1) At 12 months, the effect of P3P was similar but not significant (aOR 0.53 [95% CI 0.28-1.00]). (Fig 2) In our model, erectile function at follow-up, race and ethnicity also impact bother from ED. Men who completed P3P did not have different bother from the same levels of UI at 3 or 6 months, compared to non-completers (3 month: aOR 0.55 [95% CI 0.26-1.16]; 6 month; aOR 1.09 [95% CI 0.40-2.94]). CONCLUSIONS: Men who used a DA experienced decreased bother from post prostatectomy ED compared to non-completers. However, P3P completion did not impact bother from post prostatectomy UI. Source of Funding: NIDDK F32 DK126232; Blue Cross Blue Shield of Michigan © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e409-e409 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Giulia I. Lane More articles by this author Ji Qi More articles by this author Stephanie Ferrante More articles by this author Roshan Paudel More articles by this author Daniela Wittmann More articles by this author Lauren Wallner More articles by this author Chad Ellimoottil More articles by this author James Montie More articles by this author J. Quentin Clemens More articles by this author for the Michigan Urological Surgery Improvement Collaborative More articles by this author Expand All Advertisement Loading ...

Association of the anorectal microbiome and patient-reported gastrointestinal outcomes in patients with anal cancer.

e15504 Background: Among patients with anal cancer undergoing chemoradiotherapy, the association between the microbiome and toxicity is not well documented. We sought to quantify the gastrointestinal-related patient-reported outcomes (PROs) and local microbiome profiles of patients with anal cancer receiving chemoradiotherapy in order to check for potential profiles that can help in predicting toxicity during treatment. Methods: We prospectively followed patients with non-metastatic squamous cell carcinoma of the anal canal who received definitive chemoradiotherapy. Anorectal swab samples were collected before treatment initiation and at 4 subsequent timepoints. Consequently, PROs were collected using the bowel subdomain of the Expanded Prostate Cancer Index Composite (EPIC). Samples were sequenced using 16S rRNA of the V4 region. Sequence reads were grouped by amplicon sequence variants (ASV’s) representative of unique bacterial species. We then used Linear discriminant analysis Effect Size (LEfSe) with an effect size of 4 to identify taxa at baseline that were differentially enriched in patients with high vs. low toxicity by end of treatment. We compared the EPIC scores with the relative abundance of species identified in the LEfSe using a paired Wilcoxon test. Results: The study included 22 patients (18 women and 4 men), whose median age was 59 years. Most patients were Stage III (59%) with negative HIV status (94%). The majority of patients (91%) received standard of care chemoradiotherapy. Overall toxicity was the highest at week 5 of treatment. At all individual time points, alpha diversity of the microbiome did not correlate with patient-reported GI function, additionally overall baseline diversity was not predictive of eventual GI outcomes. The LEfSe identified that patients with low patient reported toxicity at week 5 had higher of abundance of Selenomonas at baseline, while patients with higher toxicity had high abundance of baseline Actinobacteria, Peptoniphilus, Clostridiales , and Clostridia. When comparing the relative abundance of bacterial species among patients with high and low toxicities, patients with higher relative abundance of Clostridia and Actinobacteria had significantly higher toxicity (p = 0.03). Conclusions: Certain microbiome profiles at baseline are associated with anal cancer patients’ gastrointestinal-related PROs during chemoradiation. Our data provide novel avenues to study the potential uses of the local microbiome as a biomarker in predicting treatment toxicities in anal cancer.

Longitudinal predictive ability of mapping algorithms: Secondary analysis of NRG Oncology/RTOG 0415.

60 Background: Mapping algorithms informing economic evaluations are often derived using baseline data from clinical trials. It is unclear if these algorithms can predict health utilities accurately in post-intervention data. Thus, this study examines the longitudinal predictive ability of mapping algorithms derived from baseline trial data and explores the factors associated with prediction errors. Methods: This methodological study utilized data from an international, multicenter, randomized controlled trial of patients with low-risk prostate cancer (PC), conducted by NRG Oncology (NCT00331773). In addition to patient demographic and clinical data, this study utilized PRO data collected at baseline and 6, 12 and 24 months post-intervention. The Expanded Prostate Cancer Index Composite (EPIC) questionnaire measures health-related quality-of-life (HRQoL) and has four domains (urinary, sexual, hormonal, and bowel) and two subdomains per domain (function and bother); EuroQOL-5D-3L (EQ5D) captures health utilities. Ordinary Least Squares (OLS) regression models were used to map EPIC scores to EQ5D utilities in the baseline data through 5-fold cross-validation. Predictive performance was tested in the post-intervention data; predicted and reported utilities were compared using t-tests, and the absolute prediction error was modeled using fixed effects, as a function of baseline demographic and clinical covariates, as well as observed and predicted EQ5D utilities. Results: A total of 267 (199) patients had complete EQ5D and EPIC domain (or subdomain) data at baseline and all subsequent assessments. In the EPIC domain sample, mean ± standard deviation observed EQ5D utility was 0.90±0.13 at baseline, 0.92±0.11 at 6 months, 0.90±0.13 at 12 months and 0.89±0.14 at 24 months. Mean absolute differences (MDs) between reported and predicted were lower for models using EPIC subdomain data compared to EPIC domain data, and generally decreased as the time of assessment increased. The mapping functions over-predicted utilities for patients in perfect health while the prediction errors were increasingly negative for lower reported EQ5D scores. According to the fixed effects model for EPIC domain data, lower observed and predicted baseline EQ5D scores, and time of assessment were significant predictors of the absolute prediction error; for EPIC subdomain data, lower observed and predicted baseline EQ5D scores, hormonal bother and function, and bowel function significantly predicted the absolute prediction error. Conclusions: This study is the first to demonstrate the longitudinal validity of EPIC questionnaire, and builds upon existing research on longitudinal validity of mapping functions. The low MDs in prediction errors in post-intervention data indicate that the mapping functions are sensitive to treatment effect, thereby increasing confidence in their use in economic evaluations in PC.

Biochemical Control and Toxicity Outcomes of Stereotactic Body Radiation Therapy Versus Low-Dose-Rate Brachytherapy in the Treatment of Low- and Intermediate-Risk Prostate Cancer

Low-dose-rate (LDR) brachytherapy and stereotactic body radiation therapy (SBRT) have both shown acceptable outcomes in the treatment of low- and intermediate-risk prostate cancer. Minimal data have been published directly comparing rates of biochemical control and toxicity with these 2 modalities. We hypothesize that LDR and SBRT will provide similar rates of biochemical control. All low- and intermediate-risk patients with prostate cancer treated definitively with SBRT or LDR between 2010 and 2018 were captured. Phoenix definition was used for biochemical failure. Independent t tests were used to compare baseline characteristics, and repeated measure analysis of variance test was used to compare American Urologic Association (AUA) and the Expanded Prostate Cancer Index Composite (EPIC) scores between treatment arms over time. Biochemical control was estimated using the Kaplan-Meier method. Differences in acute and late toxicity were assessed via Pearson χ2. In the study, 219 and 118 patients were treated with LDR and SBRT. Median follow-up was 4.3 years (interquartile range, 3.1-6.1). All patients treated with LDR received 125.0 Gy in a single fraction. SBRT consisted of 42.5 Gy in 5 fractions. Five-year biochemical control for LDR versus SBRT was 91.6% versus 97.6% (P = .108). LDR patients had a larger increase in mean AUA scores at 1 month (17.2 vs 10.3, P < .001) and 3 months posttreatment (14.0 vs 9.7, P < .001), and in mean EPIC scores at 1 month (15.7 vs 13.8, P < .001). There was no significant difference between LDR and SBRT in late grade 3 genitourinary toxicity (0.9% vs 2.5%, P = .238); however, LDR had lower rates of late grade 3 gastrointestinal toxicity (0.0% vs 2.5%, P = .018). Our data show similar biochemical control and genitourinary toxicity rates at 5 years for both SBRT and LDR, with slightly higher gastrointestinal toxicity with SBRT and higher AUA and EPIC scores with LDR.

A Phase Ⅱ Trial of Stereotactic Body Radiotherapy Using 4 Fractions for Patients With Localized Prostate Cancer

To report the results from our phase Ⅱ study of stereotactic body radiotherapy (SBRT) delivering 36 Gy in 4 fractions for patients with localized prostate cancer. From 2015 to 2018, 55 patients were enrolled and treated with SBRT delivering 36 Gy in 4 fractions. Most patients were categorized as intermediate-risk (n = 31) or high-risk (n = 20). The median age was 73 years (range, 54–86). Two-thirds of the patients (n = 37) received androgen deprivation therapy. The median follow-up duration was 30 months. The Radiation Therapy Oncology Group and National Cancer Institute - Common Toxicity Criteria version 4 was used for toxicity assessment. Quality of life (QOL) outcomes were also evaluated using the Expanded Prostate Cancer Index Composite (EPIC). Protocol treatments were completed for all patients. Four patients had biochemical failures. Three patients had clinical failures. One patient died of gastric cancer. The 3-year biochemical control rate was 90.8%. Acute grade 2 genitourinary (GU) and gastrointestinal (GI) toxicities were observed in 5 (9%) and 6 (11%) patients, respectively. No grade 3 or higher acute toxicities were observed. Late grade 2 GU and GI toxicities were observed in 6 (11%) and 5 (9%) patients, respectively. One patient (1.8%) had late grade 3 GU toxicity (radiation cystitis) 2.5 years after treatment. EPIC scores slightly decreased during the acute phase and recovered 3 months after treatment. Our phase II study showed that SBRT delivering 36 Gy in 4 fractions was safe and effective with favorable QOL outcomesTabled 1Abstract 2614; Table; Patient-reported outcomes assessed by Expanded Prostate Cancer Index Compositepre2w1m3m6m9m12m18m24mUrinary83.69 (12.20)66.57 (25.52)85.79 (15.21)90.44 (18.34)92.00 (11.68)88.62 (17.06)87.39 (17.01)87.39 (17.07)82.79 (22.50)Bowel89.93 (11.00)89.93 (11.00)80.18 (20.17)88.04 (12.02)89.63 (12.58)88.44 (11.89)88.45 (10.19)89.76(8.68)88.02 (10.34)Sexual33.57 (12.61)31.39 (12.64)31.84 (5.64)32.34 (10.31)31.37 (7.85)30.08 (7.07)32.45 (13.22)33.00 (9.28)32.06 (8.34)Hormone84.37 (17.20)80.16 (19.19)87.06 (12.82)88.04 (12.55)89.46 (11.96)89.86 (9.33)90.63 (12.41)88.92 (11.74)93.54 (9.78)mean (SD) Open table in a new tab

Rectum Dose-Volume Histogram (DVH) Parameters And Patient-Reported EPIC-Bowel Domain For Patients Undergoing Radiotherapy (RT) For Prostate Cancer (PC): A Single-Center Prospective Registry Experience

Prostate cancer therapy toxicities can affect QOL. We report one of the first analyses of rectal dose and changes in QOL measured with the EPIC bowel domain in PC patients treated with curative intent RT in a large, single-institution prospective registry. Two hundred fifty-two pts with localized PC were treated with curative intent RT from 2016- 2018 on an IRB approved prospective registry. The Expanded Prostate Cancer Index Composite (EPIC) health-related QOL instrument was administered at baseline, end-of-treatment, 3, 6, 12 months (m), and then annually. A higher EPIC score implies less bowel symptom burden. DVH parameters for the rectal structure were computed, Dx was the dose (Gy) to a % of the rectum and Vx was the % volume receiving a given dose (Gy). Rectal dose was analyzed using BED (alpha/beta = 3), EQD2Gy, and total dose. In order to determine optimal cut-points to find clinically meaningful DVH, we utilized logistic regression and defined the ‘best’ cut-point to be the value that maximized Youden’s Index. Repeated measures mixed models were then implemented to determine the effect of patient, clinical, and treatment factors (including DVH) on patient-reported bowel symptom burden (EPIC-Bowel). Median follow-up was 20mo(range:2.5–40), pre-RT PSA = 6.12(1.3–129), T Stage T1c(T1b–T3b), Gleason Score 7(range 6-10), and 99% N0. The median prescribed dose was 70Gy (38–79.2) in 5 to 44 fractions. Standard fractionation (1.8-2Gy) was used in 120 pts (48.2%), moderate hypofractionation (2.5-3Gy) in 87 pts (35.1%), and extreme hypofractionation (>6Gy) in 42 pts (16.7%). Globally, treatment had minimal effect over EPIC-bowel scores which remained unchanged over time, with a median baseline = (96.4), end-of-treatment = (94.6), 3mo = (95.4), 6mo = (96.4), 12m = (94.6), and 24m = (96.4). However, rectal dose affected QOL with the strongest DVH signals noted for BED V51Gy and EQD2 V22Gy—with an optimal cut-point of 14.4% and 16.4%, respectively. On multivariate modeling BED V51Gy >14.4% was significantly associated with a decline of the epic bowel domain of 2.1 points (p = 0.01), and an EQD2 V22Gy >16.4% was significantly associated with a decline of 2.3 points (p<0.003). Rectal dose, specifically BED V51Gy>14.3% and EQD2 V22Gy>16.4%, are significantly associated with decline in bowel related QOL in patients undergoing definitive RT for localized PC. This is one of the first studies to examine rectal dose and correlate them to patient reported treatment related QOL.

Patient-Reported GI Outcomes in Patients With Anal Cancer Receiving Modern Chemoradiation.

Among patients with anal cancer, chemoradiotherapy is often associated with toxicities that diminish quality of life. We describe the GI-related patient-reported outcomes (PROs) of patients with anal cancer receiving chemoradiotherapy to improve patient-physician communication. We prospectively followed patients with nonmetastatic squamous cell carcinoma of the anal canal who received definitive chemoradiotherapy. Patients completed the bowel subdomain of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire before treatment and at 4 subsequent timepoints. We used the paired Wilcoxon test to compare EPIC scores at different times. The study included 21 patients; median age was 57 years. Most patients (52%) had T2 and either N0 or N1 disease (81%). Most patients (91%) received chemotherapy with cisplatin-fluorouracil and either intensity-modulated radiotherapy or volumetric modulated arc therapy. Compared with the patients' median overall summary score at baseline (66), their median score at 1 week (82) was higher (P = .009), whereas their median score at 5 weeks (54) was lower (P = .025). The patients' median overall summary score at baseline and at 3 months did not differ (P = .919). Three months after radiotherapy, most patients reported minimal adverse effects compared with baseline. The GI-related PROs of patients with anal cancer tend to fluctuate during radiotherapy but return to baseline by 3 months, at which time most patients report few or no residual adverse effects. We provide a clear timeline of GI acute toxicity using sequential PRO measurements that will improve patient-physician communication regarding expectations for cancer treatment.

Patient-reported gastrointestinal outcomes in patients with anal cancer.

4055 Background: Among patients with anal cancer, chemoradiotherapy tends to offer an excellent prognosis but is often associated with undesirable toxicities that diminish quality of life. We sought to quantify the gastrointestinal-related patient-reported outcomes (PROs) of anal cancer patients receiving chemoradiotherapy in order to improve patient-physician communication and shared decision making. Methods: We prospectively followed patients with non-metastatic squamous cell carcinoma of the anal canal who received definitive chemoradiotherapy. Patients reported outcomes were collected using the bowel subdomain of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire before treatment and at 4 subsequent timepoints. We used descriptive statistics to summarize the patients’ characteristics and EPIC scores, then used the paired Wilcoxon test to compare EPIC scores at different timepoints. Results: The study included 21 patients (16 women and 5 men), whose median age was 57 years. Most patients (52%) had T2, and either N0 (38%) or N1 (43%) disease. Most patients (91%) received standard of care chemoradiotherapy. Compared with the patients’ median overall summary score at baseline (66), their median score at 1 week (82) was significantly higher (p = 0.009), whereas their median score at 5 weeks (54) was significantly lower (p = 0.025). However, the patients’ median overall summary score at baseline and at 3 months did not differ significantly (p = 0.919). Three months after radiotherapy, most patients (73%) reported rarely or never having bloody stools, and most (82%) reported rarely or never being bothered by bloody stools. Overall, EPIC scores show initial improvement of all domains, followed by some worsening of symptoms before returning to baseline levels. Conclusions: Anal cancer patients’ gastrointestinal-related PROs tend to fluctuate during radiotherapy but return to baseline by 3 months, at which time most patients report few or no residual side effects. Our data provide a clear timeline of gastrointestinal acute toxicity using sequential PRO measurements that will improve patient-physician communication regarding expectations for cancer treatment and help in shared decision making.

MP74-10 INTRAOPERATIVE MEASUREMENTS OF URETHRAL LENGTH AND BLADDER NECK DIAMETER AS PREDICTORS OF URINARY CONTINENCE AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy IV (MP74)1 Apr 2020MP74-10 INTRAOPERATIVE MEASUREMENTS OF URETHRAL LENGTH AND BLADDER NECK DIAMETER AS PREDICTORS OF URINARY CONTINENCE AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY Yasuo Kohjimoto*, Masatoshi Higuchi, Yuko Ueda, Takashi Iguchi, Hiroyuki Koike, Takahito Wakamiya, Shimpei Yamashita, Kazuro Kikkawa, and Isao Hara Yasuo Kohjimoto*Yasuo Kohjimoto* More articles by this author , Masatoshi HiguchiMasatoshi Higuchi More articles by this author , Yuko UedaYuko Ueda More articles by this author , Takashi IguchiTakashi Iguchi More articles by this author , Hiroyuki KoikeHiroyuki Koike More articles by this author , Takahito WakamiyaTakahito Wakamiya More articles by this author , Shimpei YamashitaShimpei Yamashita More articles by this author , Kazuro KikkawaKazuro Kikkawa More articles by this author , and Isao HaraIsao Hara More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000960.010AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: To determine whether intraoperative measurements of urethral length (UL) and bladder neck diameter (BND) can predict patient-reported urinary continence status after robot-assisted radical prostatectomy (RARP). METHODS: Consecutive eligible patients undergoing RARP between June 2015 and March 2019 were enrolled into a prospective, longitudinal, observational cohort study. The primary outcomes were changes in urinary incontinence subscale of the Expanded Prostate Cancer Index Composite (EPIC) from baseline at 3, 6 and 12 months postoperatively. The primary exposures were UL and BND measured intraoperatively with a ruler. Other covariates included age, body mass index, NCCN risk category, nerve-sparing and weight of resected specimen. The relationship between EPIC score for urinary incontinence and intraoperative measurements (UL and BND) was evaluated using Wilcoxon-Mann-Whitney test and multivariate logistic regression analysis. RESULTS: A total of 365 patients were enrolled. The median change in EPIC score for urinary incontinence were -41.5, -21.8 and -12.5 at 3, 6, 12 months, respectively. The median UL and BND were 15mm and 17mm, respectively. Decrease in EPIC score for urinary incontinence at 12 months was smaller in patients with UL >15mm than those with UL ≤15mm (-6.3 vs -14.5, p=0.08), and so in patients with BND ≤17mm than those with BND >17mm (-6.3 vs -20.8, p=0.04). However, there were no differences between these groups at 3 and 6 months. Multivariate analyses revealed that patients with UL >15mm (OR 2.53, 95%CI 1.37-4.66, p<0.01) and those with BND ≤17mm (OR 2.70, 95%CI 1.45-5.03, p<0.01) had significantly higher odds of small decrease in EPIC score for urinary incontinence at 12 months (Table). CONCLUSIONS: The results demonstrated that longer UL and smaller BND were associated with significantly small decrease in EPIC score for urinary continence at 12 postoperatively, supporting the idea that preservation of membranous urethra and bladder neck during RARP improves continence recovery. Source of Funding: none © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1135-e1135 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Yasuo Kohjimoto* More articles by this author Masatoshi Higuchi More articles by this author Yuko Ueda More articles by this author Takashi Iguchi More articles by this author Hiroyuki Koike More articles by this author Takahito Wakamiya More articles by this author Shimpei Yamashita More articles by this author Kazuro Kikkawa More articles by this author Isao Hara More articles by this author Expand All Advertisement PDF downloadLoading ...