Expanded Prostate Cancer Index Composite For Clinical Practice Research Articles

Transversal approach via a bladder neck and prostate combined longitudinal incision versus standard approach of robotic-assisted radical prostatectomy for localized prostate cancer: a retrospective analysis

BackgroundTransversal approach for robotic-assisted radical prostatectomy via a bladder neck and prostate combined longitudinal incision (L-RALP) is a novel surgical method for patients with respectable prostate cancer.MethodsThere were 669 patients with prostate cancer underwent L-RALP or S-RALP which identified from April 2016 to April 2020. The perioperative outcomes, Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) scores, sexual function and urinary control ability were included and compared between two groups.ResultsIn the 669 patients, 277 of them were included into the final analysis. 151 patients received S-RALP and 126 received L-RALP. Baseline features were balanced. Patients in the S-RALP group had significantly shorter average surgical time (135.93 vs 150.04 min; p < 0.001) than those in L-RALP group. Intraoperative bleeding volume, early postoperative complications rates, postoperative catheter removal time and hospital stays were comparable between two groups. There was no difference in biochemical recurrence at 3, 6, 12 and 18 months of follow-up. Of note, the urinary control function recovers of patients in the L-RALP group was significantly better than those in the S-RALP group. Moreover, patients in the L-RALP group had much better results of EPIC-CP (including urinary control and total score) than those in the S-RALP group at 6 week and 3, 6, 12 and 18 months.ConclusionsBoth S-RALP and L-RALP were safe and effective with similar long-term clinical outcomes in patients with respectable prostate cancer. Patients received L-RALP had significantly better postoperative outcomes including urinary control, and recovery period.

Health-related Quality of Life in Patients With Urethral Stenosis After Radiation Treatment for Prostate Cancer

ObjectiveTo evaluate patient-reported quality of life (PRQoL) in patients presenting with membranous urethral stenosis after prostate radiotherapy. Urethral stenosis is an under-reported complication after prostate radiotherapy with a particular deficiency in PRQoL. MethodsPatients presenting with urethral stenosis after radiotherapy were retrospectively reviewed from 2004-2022. PRQoL was assessed via patient survey using the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP). Results230 patients were identified at a mean age of 67.7 years and mean time to stricture diagnosis of 63.6 months’ post-radiotherapy. Of 87 patients completing the survey, 29.9% recalled being aware of urethral stenosis as a potential complication and 51.7% had documentation of urethral stenosis as a potential complication. 33.5% of patients underwent urethroplasty, 59.6% repeat endoscopic treatment and 6.1% an indwelling catheter. 64.4% of patients reported urinary dysfunction as a “moderate” or “big” problem, 66.7% reported frequent or total incontinence, 64.4% required daily pad use and 50.6% reported incontinence as either a “moderate” or “big” problem. 85.0% reported poor or absent orgasmic dysfunction and 88.5% reported erections insufficient for sexual activity. Additionally, 47.1% of patients reported rectal pain and 31.0% reported dysuria. Depressive symptoms and fatigue were reported by 41.4% and 60.9% of patients respectively. ConclusionUrethral stenosis after radiotherapy is a clinically complex entity with a broad scope of associated symptoms including high rates of patient-reported incontinence, voiding dysfunction, sexual dysfunction, pain, bowel dysfunction and depression. This multi-focal nature combined with often insidious presentation and patient unawareness creates a uniquely challenging condition to treat.

Outcomes and Safety of Suprapubic vs Urethral Catheterization Following Pelvic Fascia‒Sparing Robotic Prostatectomy.

Urethral catheter (UC) discomfort remains a burden following robotic-assisted radical prostatectomy (RARP). Suprapubic catheters (SPCs) may reduce patient discomfort and increase satisfaction. Pelvic fascia‒sparing (PFS) RARP reduces the technical challenges of intraoperative SPC placement. We examined postoperative outcomes of SPC vs UC placement following PFS-RARP. We conducted a retrospective review of a prospective institutional review board‒approved database of PFS-RARP patients from June 2020 to December 2022 receiving SPC (n = 108) or UC (n = 104) postoperatively. Demographics and clinical and perioperative outcomes were captured. Postoperative patient-reported quality of life was measured using EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice). Patients with intraoperative complications or intraoperative leaks or undergoing salvage prostatectomy were excluded. Univariate and multivariate regression analyses were performed to compare outcomes. No significant differences in demographics or oncologic outcomes existed. There were no differences in complications, including urethral stricture or anastomotic leak. Men receiving SPC vs UC had earlier return to continence (7 vs 16 days, P < .001) and higher continence rates at catheter removal (67.6% vs 43.3%, P = .0003). On adjusted analyses, SPC was an independent predictor of continence at catheter removal (OR 2.21, P = .023). There were no differences between groups in preoperative or postoperative EPIC-CP scores, including no differences in postoperative quality of life (P = .46). SPC after PFS-RARP is a safe and feasible alternative to UC. SPC is associated with an earlier return to continence and higher continence rates at catheter removal. Use of SPC may increase overall patient satisfaction following PFS-RARP.

Radiation Therapy and Irreversible Electroporation for Intermediate Risk Prostate Cancer (RTIRE)

The objective of the RTIRE clinical trial (NCT05345444) is to demonstrate the feasibility, safety, and early oncologic efficacy of combining MRI-guided stereotactic body radiation therapy (MRgSBRT) with irreversible electroporation (IRE) for men with intermediate-risk localized prostate cancer. Inclusion criteria: 1) Men aged ≥18, 2) ECOG 0 -1, 3) Histologically confirmed intermediate risk prostate cancer per NCCN guidelines, 4) Focal grade group 2 (GG2) or 3 (GG3) cancer in multi-parametric magnetic resonance imaging (mpMRI) target, 5) Gland size < 80cc, 6) Ability to undergo IRE, 7) Ability to receive MRI-guided SBRT, 8) Ability to complete the HRQOL assessment surveys, 9) Willingness to undergo 12 month follow up biopsy. 1) Prior TURP, 2) Prior history of focal therapy, 3) Prior history of receiving pelvic radiotherapy, 4) Patient with history of inflammatory bowel disease, 5) History of bladder neck or urethral stricture. Study Design/Endpoints: This is a feasibility and safety study assessing the ability to perform IRE followed by real-time MRgSBRT. Subjects will undergo focal IRE followed by MRgSBRT (≥6 weeks after IRE) to the prostate +/- seminal vesicles prescribed to 32.5 Gy in 5 fractions. The primary endpoint of the first portion of the trial is feasibility, defined as at least 80% of subjects (8 of 10 subjects) undergoing assessment at 12-weeks post-IRE and at 6-weeks post-MRgSBRT within 1 year from enrollment of the first subject. The expansion phase will include an additional 40 subjects to assess side effect profile and early oncologic efficacy (n = 50) at 12 months post RTIRE. RTIRE has enrolled 8 subjects in 3 months and will proceed to the expansion phase. Secondary endpoints include: 1) short-term safety as measured by treatment-related adverse events, 2) oncologic efficacy as measured by number of subjects with presence of ≥GG2 cancer at 12 months post-RTIRE therapy, 3) health-related quality of life (HRQOL) as measured by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-5) 4) post-RTIRE prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability, 5) assessment of pre and post-RTIRE mpMRI changes to evaluate the area of necrosis and presence of residual tissue, 6) rates of biochemical and clinical progression and the need for secondary or adjuvant treatment following RTIRE. Enrollment: 11 Subjects RESULTS: To be determined. To be determined.

Racial differences in patient-reported outcomes among men treated with radical prostatectomy for prostate cancer.

Real-world data on racial differences in the side effects of radical prostatectomy on quality of life (QoL) are lacking. We aimed to evaluate differences in patient-reported outcome measure (PROM) among non-Hispanic Black (NHB) and non-Hispanic White (NHW) men using the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire to measure health-related QoL after radical prostatectomy. We retrospectively assessed prospectively collected PROMs using EPIC-CP scores at a tertiary care center between 2015 and 2021 for men with prostate cancer undergoing radical prostatectomy. The primary endpoint was the overall QoL score for NHB and NHW men, with a total score of 60 and higher scores indicating worse QoL. An imputed mixed linear regression model was used to examine the effect of covariates on the change in overall QoL score following surgery. A pairwise comparison was used to estimate the mean QoL scores before surgery as well as up to 24 months after surgery. Our cohort consisted of 2229 men who answered at least one EPIC-CP questionnaire before or after surgery, of which 110 (4.94%) were NHB and 2119 (95.07%) were NHW men. The QoL scores differed for NHB and NHW at baseline (2.34, 95% confidence interval [CI] 0.36-4.31, p = 0.02), 3 months (4.36, 95% CI 2.29-6.42, p < 0.01), 6 months (3.26, 95% CI 1.10-5.43, p < 0.01), and 12 months after surgery (2.48, 95% CI 0.19-4.77, p = 0.03) with NHB having worse scores. There was no difference in QoL between NHB and NHW men 24 months after surgery. A significant difference in QoL between NHB and NHW men was reported before surgery, 3, 6, and 12 months after surgery, with NHB having worse QoL scores. However, there was no long-term difference in reported QoL. Our findings inform strategies that can be implemented to mitigate racial differences in short-term outcomes.

MP80-17 RACIAL DIFFERENCES IN PATIENT-REPORTED OUTCOMES AMONG MEN TREATED WITH RADICAL PROSTATECTOMY FOR PROSTATE CANCER

You have accessJournal of UrologyCME1 Apr 2023MP80-17 RACIAL DIFFERENCES IN PATIENT-REPORTED OUTCOMES AMONG MEN TREATED WITH RADICAL PROSTATECTOMY FOR PROSTATE CANCER Mara Koelker, Muhieddine Labban, Nicola Frego, Jamie Ye, Stuart R. Lipsitz, Harrison Taylor Hubbell, Maria Edelen, Dejan K. Filipas, Grant L. Steele, Kevin Salinas, Jonathan Makanjuola, Caroline M. Moore, Christian P. Meyer, Adam S. Kibel, Alexander P. Cole, and Quoc-Dien Trinh Mara KoelkerMara Koelker More articles by this author , Muhieddine LabbanMuhieddine Labban More articles by this author , Nicola FregoNicola Frego More articles by this author , Jamie YeJamie Ye More articles by this author , Stuart R. LipsitzStuart R. Lipsitz More articles by this author , Harrison Taylor HubbellHarrison Taylor Hubbell More articles by this author , Maria EdelenMaria Edelen More articles by this author , Dejan K. FilipasDejan K. Filipas More articles by this author , Grant L. SteeleGrant L. Steele More articles by this author , Kevin SalinasKevin Salinas More articles by this author , Jonathan MakanjuolaJonathan Makanjuola More articles by this author , Caroline M. MooreCaroline M. Moore More articles by this author , Christian P. MeyerChristian P. Meyer More articles by this author , Adam S. KibelAdam S. Kibel More articles by this author , Alexander P. ColeAlexander P. Cole More articles by this author , and Quoc-Dien TrinhQuoc-Dien Trinh More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003357.17AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We aim to evaluate differences in patient-reported outcomes (PROM) using the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire to measure patient-reported health-related quality of life (QoL) after radical prostatectomy. METHODS: We retrospectively assessed prospectively collected patient-reported outcomes using EPIC-CP scores at a tertiary care center using the institutional electronic health record between 2015 and 2021 for men with prostate cancer undergoing radical prostatectomy. The primary endpoint was overall QoL scores. An imputed mixed linear regression model was used to examine the effect of covariates on the change in overall QoL scores. A pairwise comparison was used to estimate the mean QoL scores before surgery as well as 3 months, 6 months, 12 months, and 24 months after surgery for Non-Hispanic Black (NHB) and Non-Hispanic White (NHW) men. RESULTS: Our cohort consisted of 2,229 men that answered at least one EPIC-CP questionnaire before or after surgery of which 110 (4.94%) were NHB and 2,119 (95.07%) were NHW men. The worst QoL scores were reported 3 months after radical prostatectomy with an average score of 21.52 (95%CI 19.83-23.21). The QoL scores were worse for NHB vs. NWH with a difference of (2.34, 95%CI 0.36-4.31, p=0.02) at baseline, (4.36, 95%CI 2.29-6.42, p<0.01) at 3 months after surgery, and (3.26, 95%CI 1.10-5.43, p<0.01) 6 months after surgery (Figure 1). However, there was no difference in QoL between NHB and NWH men at 12 months and 24 months after surgery. CONCLUSIONS: We found that NHB had worse QoL score than NHW men before surgery, 3 months, and 6 months after surgery. However, there was no long-term difference in reported QoL between NHB and NHW men at 12 months and 24 months after surgery. Our findings can inform preoperative counseling of men undergoing radical prostatectomy. Further research is warranted to understand the racial differences in postoperative recovery after radical prostatectomy. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1159 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Mara Koelker More articles by this author Muhieddine Labban More articles by this author Nicola Frego More articles by this author Jamie Ye More articles by this author Stuart R. Lipsitz More articles by this author Harrison Taylor Hubbell More articles by this author Maria Edelen More articles by this author Dejan K. Filipas More articles by this author Grant L. Steele More articles by this author Kevin Salinas More articles by this author Jonathan Makanjuola More articles by this author Caroline M. Moore More articles by this author Christian P. Meyer More articles by this author Adam S. Kibel More articles by this author Alexander P. Cole More articles by this author Quoc-Dien Trinh More articles by this author Expand All Advertisement PDF downloadLoading ...

MP67-10 CLINICAL FACTORS ASSOCIATED WITH EARLY RETURN OF URINARY CONTROL FOLLOWING RETZIUS-SPARING ROBOTIC-ASSISTED RADICAL PROSTATECTOMY

You have accessJournal of UrologyCME1 Apr 2023MP67-10 CLINICAL FACTORS ASSOCIATED WITH EARLY RETURN OF URINARY CONTROL FOLLOWING RETZIUS-SPARING ROBOTIC-ASSISTED RADICAL PROSTATECTOMY Ruben Blachman-Braun, Dinno F Mendiola, Carole Lahana, Chad R. Ritch, Sanoj Punnen, Bruno Nahar, Dipen J Parekh, and Mark L Gonzalgo Ruben Blachman-BraunRuben Blachman-Braun More articles by this author , Dinno F MendiolaDinno F Mendiola More articles by this author , Carole LahanaCarole Lahana More articles by this author , Chad R. RitchChad R. Ritch More articles by this author , Sanoj PunnenSanoj Punnen More articles by this author , Bruno NaharBruno Nahar More articles by this author , Dipen J ParekhDipen J Parekh More articles by this author , and Mark L GonzalgoMark L Gonzalgo More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003330.10AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: A potential side effect following radical prostatectomy is urinary incontinence. Retzius-sparing robotic-assisted radical prostatectomy (RS-RARP) has been associated with improved urinary control outcomes. We investigated the impact of clinical variables and intraoperative surgical findings on recovery of urinary control following RS-RARP. METHODS: Data was collected from a single-surgeon, single-institution prospective database of patients who underwent RS-RARP from May 2020 to July 2022 with≥3 months of follow up. Those without EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) or unknown prostate size at baseline were excluded. Daily pad use and EPIC-CP urinary incontinence symptom score domain (EPIC-CP UISS) were used to assess continence status. Multivariable-adjusted logistic regression was performed to assess clinical variables associated with 3-month continence (EPIC-CP UISS≤3) following surgery. RESULTS: A total of 295 men were analyzed, 49 (16.6%) had a median lobe (ML) confirmed intraoperatively, 27 (9.2%) required bladder neck reconstruction (BNR) using a tennis-racket suturing technique, and 139 (47.1%) had bilateral nerve-sparing (BNS). A total of 145 (49.2%) and 224 (76.6%) men reported using 0 or 0-1 pad per day ≤1 week following catheter removal, respectively. At 3-month follow up, 65.4% and 86.1% of men reported using 0 or 0-1 pad per day, respectively; 81.7% of men had EPIC-CP UISS ≤3. Approximately 90% and 97% of men reported using 0 or 0-1 pad per day 12 months following surgery, respectively. Diabetes mellitus (DM) was associated with worse continence (OR=0.403, p=0.027), and BNS was associated with better continence (OR=3.595, p=0.003) at 3 months. Prostate size, presence of a ML, and BNR were not associated with worse urinary control at 3 months (Table 1). CONCLUSIONS: Early continence rates after RS-RARP are encouraging with the majority of men being completely dry or using 0-1 pad per day within 1 week of catheter removal and by 3 months following surgery. DM has a negative impact and BNS has a positive impact on return of early continence. Age, prostate size, presence of ML, and BNR did not have a significant impact on early recovery of urinary control after RS-RARP. Source of Funding: No © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e946 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ruben Blachman-Braun More articles by this author Dinno F Mendiola More articles by this author Carole Lahana More articles by this author Chad R. Ritch More articles by this author Sanoj Punnen More articles by this author Bruno Nahar More articles by this author Dipen J Parekh More articles by this author Mark L Gonzalgo More articles by this author Expand All Advertisement PDF downloadLoading ...

Radiation therapy and irreversible electroporation for intermediate risk prostate cancer (RTIRE).

TPS403 Background: The objective of the RTIRE clinical trial (NCT05345444) is to demonstrate the feasibility, safety, and early oncologic efficacy of combining MRI-guided stereotactic body radiation therapy (MRgSBRT) with irreversible electroporation (IRE) for men with intermediate-risk localized prostate cancer. Methods: Inclusion criteria: 1) Men aged ≥18, 2) ECOG 0 –1, 3) Histologically confirmed intermediate risk prostate cancer per NCCN guidelines, 4) Focal grade group 2 (GG2) or 3 (GG3) cancer in multi-parametric magnetic resonance imaging (mpMRI) target, 5) Gland size &lt; 80cc, 6) Ability to undergo IRE, 7) Ability to receive MRI-guided SBRT, 8) Ability to complete the HRQOL assessment surveys, 9) Willingness to undergo 12 month follow up biopsy. Exclusion criteria: 1) Prior TURP, 2) Prior history of focal therapy, 3) Prior history of receiving pelvic radiotherapy, 4) Patient with history of inflammatory bowel disease, 5) History of bladder neck or urethral stricture. Study Design/Endpoints: This is a feasibility and safety study assessing the ability to perform IRE followed by real-time MRgSBRT. Subjects will undergo focal IRE followed by MRgSBRT (&gt;6 weeks after IRE) to the prostate +/- seminal vesicles prescribed to 32.5 Gy in 5 fractions. The primary endpoint of the first portion of the trial is feasibility, defined as at least 80% of subjects (8 of 10 subjects) undergoing assessment at 12-weeks post-IRE and at 6-weeks post-MRgSBRT within 1 year from enrollment of the first subject. The expansion phase will include an additional 40 subjects to assess side effect profile and early oncologic efficacy (n=50) at 12 months post RTIRE. RTIRE has enrolled 8 subjects in 3 months and will proceed to the expansion phase. Secondary endpoints include: 1) short-term safety as measured by treatment-related adverse events, 2) oncologic efficacy as measured by number of subjects with presence of ≥GG2 cancer at 12 months post-RTIRE therapy, 3) health-related quality of life (HRQOL) as measured by Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-5) 4) post-RTIRE prostate-specific antigen (PSA) kinetics including time to PSA nadir and post-nadir PSA stability, 5) assessment of pre and post-RTIRE mpMRI changes to evaluate the area of necrosis and presence of residual tissue, 6) rates of biochemical and clinical progression and the need for secondary or adjuvant treatment following RTIRE. Clinical trial information: NCT05345444 .

Simultaneous integrated boost (SIB) stereotactic body radiotherapy (SBRT) for prostate and pelvic nodes in high risk, node positive and oligometastatic prostate cancers: Safety, efficacy and quality of life outcome measures.

121 Background: SBRT in high risk (HR), node positive (N+) and oligometastatic (OM) prostate cancers is limited by pelvic nodal coverage, larger treatment volumes and use of hormone therapy. We report the safety, efficacy and patient reported quality of life measures (QOL) for SIB-SBRT for prostate and pelvic nodal treatment in HR, N+ and OM (non-regional node or skeletal deposits) cohorts. Methods: 22 patients of NCCN category HR, N+, OM adenocarcinoma prostate and all staged by MRI prostate and PSMA PETCT scan received SIB-SBRT from April 2019 to October 2021. All received long term androgen (ADT) deprivation therapy (80%) or surgical castration (20%). ADT was neo-adjuvant, concomitant and adjuvant for at least 2 years and for OM 2nd generation hormone treatment. SIB-SBRT to prostate and pelvic nodal regions (until common iliac level) was 35-36.25 Gy and 25 Gy in 5 fractions respectively. Post ADT gross PSMA avid nodes and skeletal deposits received 30 Gy in 5 fractions. SIB-SBRT was by volumetric modulated arc therapy (VMAT) with intrafraction imaging and hexapod robotic couch corrections on alternate days. Baseline IPSS and Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) QOL recorded and then post SIB-SBRT at 6 weeks and then 3 monthly till 2 years. Dosimetry followed standard published literature. Results: 22 patients were treated over 3 years with median age of 70 years. The median PSA at baseline was 45ng/ml with 90% Gleason score 8+. The OM disease included nonregional nodes or 1-2 skeletal deposits. After median follow up of 20 months acute grade 2 genitourinary (GU) and gastrointestinal (GI) toxicities were 10% and 12%, respectively. Late grade 2 GU and GI toxicities were 4% and 9%, respectively. Late grade 3 GU and GI toxicity was seen in 2 patients each requiring medical management. 2- year overall survival and biochemical failure-free survival was 95% and 90% respectively. Baseline median IPSS score was 9 and median EPIC CP score was 12/60. Mean urinary incontinence domain scores worsened significantly from baseline to 6 months and obstructive scores improved from baseline to 6 months with more than 95% patients not using any pads at 6 months. Bowel frequency scores were maximum at 6 weeks post SBRT and it persisted till 6 months. Sexual function scores declined gradually and recovered only in a few at last follow up. Vitality/hormonal scores were unchanged from baseline till 6 months. Conclusions: SIB-SBRT for HR, N+ and OM prostate cancers is safe and effective, with good QOL. The encouraging PSA control and minimal grade 3 toxicity and favorable therapeutic ratio achieved reflect the feasibility of LINAC based SIB-SBRT. This warrants long term follow-up with effective bladder/rectal protocol measures and optimal use of ADT in a prospective setting.

MP16-12 PREDICTORS OF PATIENT-REPORTED OUTCOMES COMPLETION IN PATIENTS UNDERGOING RADICAL PROSTATECTOMY AND ASSOCIATIONS BETWEEN RESPONSE FREQUENCY AND FUNCTIONAL OUTCOMES

You have accessJournal of UrologyCME1 May 2022MP16-12 PREDICTORS OF PATIENT-REPORTED OUTCOMES COMPLETION IN PATIENTS UNDERGOING RADICAL PROSTATECTOMY AND ASSOCIATIONS BETWEEN RESPONSE FREQUENCY AND FUNCTIONAL OUTCOMES Daniel Frendl, Wesley Chou, Douglas Dahl, Jeffrey Twum-Ampofo, Adam Feldman, Francis McGovern, Michael Blute, Marcela del Carmen, Marilyn Heng, Rachel Sisodia, and Matthew Wszolek Daniel FrendlDaniel Frendl More articles by this author , Wesley ChouWesley Chou More articles by this author , Douglas DahlDouglas Dahl More articles by this author , Jeffrey Twum-AmpofoJeffrey Twum-Ampofo More articles by this author , Adam FeldmanAdam Feldman More articles by this author , Francis McGovernFrancis McGovern More articles by this author , Michael BluteMichael Blute More articles by this author , Marcela del CarmenMarcela del Carmen More articles by this author , Marilyn HengMarilyn Heng More articles by this author , Rachel SisodiaRachel Sisodia More articles by this author , and Matthew WszolekMatthew Wszolek More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002549.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patient-reported outcomes measures (PROMs) are key to evaluating quality of life after radical prostatectomy (RP). However, routine PROMs collection and analysis of factors influencing response after RP are lacking. Thus, we evaluate predictors of PROMs completion in RP patients and associations between response frequency and functional outcomes. METHODS: We reviewed patients who underwent RP from 2016-2017 at our institution. The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) was administered preoperatively and up to 30 months postoperatively. Completion was defined as response to ≥1 EPIC-CP. We used logistic regression to assess predictors of completion and Kaplan-Meier estimators to analyze return of urinary and sexual function based on number of completed PROMs. RESULTS: Of 634 patients who underwent RP, 392 (62%) completed ≥1 EPIC-CP. On univariate analysis, non-white race, Medicaid insurance, and limited English proficiency were associated with lower completion, while an active online patient portal was associated with completion (Table 1). Of these factors, only an active portal was still associated with greater completion on multivariate analysis (OR 4.0, 95% CI 2.7-5.9, Table 1). Factors such as PSA level, nerve sparing, pathologic Gleason Grade Group, and pT stage were not predictors, although pN1 was associated with lower completion vs. those without node dissection. When stratified by low vs. high number of responses, time to return of urinary or sexual function did not differ (Fig. 1). CONCLUSIONS: Despite a high completion rate in our cohort, patients without online portal access may require more support to complete PROMs. Further research on outcomes in respondents and non-respondents is warranted, although encouragingly, we did not observe significant differences in various cancer characteristics between these groups as well as for functional outcomes between low and high frequency responders. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e280 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Frendl More articles by this author Wesley Chou More articles by this author Douglas Dahl More articles by this author Jeffrey Twum-Ampofo More articles by this author Adam Feldman More articles by this author Francis McGovern More articles by this author Michael Blute More articles by this author Marcela del Carmen More articles by this author Marilyn Heng More articles by this author Rachel Sisodia More articles by this author Matthew Wszolek More articles by this author Expand All Advertisement PDF DownloadLoading ...

MP15-01 LONGITUDINAL PATIENT-REPORTED OUTCOMES MEASURES DEMONSTRATE CONTINUED IMPROVEMENTS IN URINARY AND ERECTILE FUNCTION AFTER RADICAL PROSTATECTOMY THROUGH 30 MONTHS

You have accessJournal of UrologyCME1 May 2022MP15-01 LONGITUDINAL PATIENT-REPORTED OUTCOMES MEASURES DEMONSTRATE CONTINUED IMPROVEMENTS IN URINARY AND ERECTILE FUNCTION AFTER RADICAL PROSTATECTOMY THROUGH 30 MONTHS Daniel Frendl, Wesley Chou, Matthew Wszolek, Francis McGovern, Adam Feldman, Michael Blute, Jeffrey Twum-Ampofo, Marcela del Carmen, Marilyn Heng, Rachel Sisodia, and Douglas Dahl Daniel FrendlDaniel Frendl More articles by this author , Wesley ChouWesley Chou More articles by this author , Matthew WszolekMatthew Wszolek More articles by this author , Francis McGovernFrancis McGovern More articles by this author , Adam FeldmanAdam Feldman More articles by this author , Michael BluteMichael Blute More articles by this author , Jeffrey Twum-AmpofoJeffrey Twum-Ampofo More articles by this author , Marcela del CarmenMarcela del Carmen More articles by this author , Marilyn HengMarilyn Heng More articles by this author , Rachel SisodiaRachel Sisodia More articles by this author , and Douglas DahlDouglas Dahl More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002544.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patient-reported outcomes measures (PROMs) are critical for tracking quality of life and functional outcomes. Urinary incontinence and sexual dysfunction are common adverse effects experienced after radical prostatectomy (RP). PROMs may help inform patients about expected recovery after RP. We assess long-term patient-reported return of urinary and sexual function after RP in routine practice. METHODS: The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) questionnaire was administered to all patients who underwent RP at our institution in 2016-2017. Questionnaires were administered preoperatively and up to 30 months postoperatively. Primary outcomes of interest were postoperative return of urinary and sexual function, respectively defined as either no urinary pads or use of one pad per day without overall urinary bother, and either erections sufficient for intercourse or erections sufficient for masturbation/foreplay without overall sexual bother. We used Kaplan-Meier estimators to evaluate time to return of these outcomes. RESULTS: Of 634 patients who underwent RP, we included 392 who completed ≥1 questionnaire; 184/392 (47%) had preoperative and postoperative responses. The mean age was 62.4 years (SD 6.5), with 93% of patients having a nerve-sparing surgery and 38% having pathologic extracapsular (≥T3a) disease (Table 1). At 12 months, unadjusted Kaplan-Meier estimates for cumulative likelihood of return of urinary function was 55%, improving to 98% by 30 months (Fig. 1A). For patients with good baseline sexual function who underwent nerve-sparing surgery, 24% reported return of sexual function by 12 months, improving to 71% at 30 months (Fig. 1B). CONCLUSIONS: Routine electronic solicitation of PROMs in our practice showed continued improvements in continence and sexual function up to 30 months postoperatively. These findings may help inform patients regarding typical functional recovery trajectories after RP. Source of Funding: None © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e241 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Daniel Frendl More articles by this author Wesley Chou More articles by this author Matthew Wszolek More articles by this author Francis McGovern More articles by this author Adam Feldman More articles by this author Michael Blute More articles by this author Jeffrey Twum-Ampofo More articles by this author Marcela del Carmen More articles by this author Marilyn Heng More articles by this author Rachel Sisodia More articles by this author Douglas Dahl More articles by this author Expand All Advertisement PDF DownloadLoading ...

Randomized Trial of Conventional Versus Conventional Plus Fluciclovine (18F) Positron Emission Tomography/Computed Tomography–Guided Postprostatectomy Radiation Therapy for Prostate Cancer: Volumetric and Patient-Reported Analyses of Toxic Effects

Postprostatectomy radiation therapy planning with fluciclovine (18F) positron emission tomography (PET)/computed tomography has demonstrated improved disease-free survival over conventional only (computed tomography- or magnetic resonance imaging-based) treatment planning. We hypothesized that incorporating PET would result in larger clinical target volumes (CTVs) without increasing patient-reported toxic effects. From 2012 to 2019, 165 postprostatectomy patients with detectable prostate-specific antigen were randomized (arm 1 [no PET]: 82; arm 2 [PET]: 83). Prostate bed target volumes with (CTV1: 45.0-50.4 Gy/1.8 Gy) or without (CTV2/CTV: 64.8-70.2 Gy/1.8 Gy) pelvic nodes, as well as organ-at-risk doses, were compared pre- versus post-PET (arm 2) using the paired t test and between arms using the t test. Patient-reported outcomes used International Prostate Symptom Score and Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP). Univariate and multivariable analyses were performed and linear mixed models were fitted. Median follow-up of the whole cohort was 3.52 years. All patients had baseline patient-reported outcomes, 1 patient in arm 1 and 3 patients in arm 2 withdrew, and 4 arm 2 patients had extrapelvic uptake on PET with radiotherapy aborted, leaving 81 (arm 1) and 76 patients (arm 2) for analysis of toxic effects. Mean CTV1 (427.6 vs 452.2 mL; P=.462, arm 1 vs arm 2) and CTV2/CTV (137.18 vs 134.2 mL; P=.669) were similar before PET incorporation. CTV1 (454.57 vs 461.33 mL; P=.003) and CTV2/CTV (134.14 vs 135.61 mL; P < .001) were modestly larger after PET incorporation. Although V40 Gy (P=.402 and P=.522 for rectum and bladder, respectively) and V65 Gy (P=.157 and P=.182 for rectum and bladder, respectively) were not significantly different pre- versus post-PET, penile bulb dose significantly increased post-PET (P < .001 for both V40 Gy and V65 Gy). On univariate and multivariable analyses, arm was not significant for any EPIC-CP subdomain. International Prostate Symptom Score and EPIC-CP linear mixed models were not significantly different between arms. Despite larger CTVs after incorporation of fluciclovine (18F) PET, we found no significant difference in patient-reported toxic effects with long-term follow-up.

Experience Measures after Radical Prostatectomy: A Register-Based Study Evaluating the Association between Patient-Reported Symptoms and Quality of Information.

Patient-reported data are important for quality assurance and improvement. Our main aim was to investigate the association between patient-reported symptoms among patients undergoing radical prostatectomy and their perceived quality of information before treatment. In this single-centre study, 235 men treated with robotic-assisted radical prostatectomy (RARP) between August 2017 and June 2019, responded to a follow-up questionnaire 20–42 months after surgery. A logistic regression analysis was performed to assess the association between patient-reported symptoms, measured with Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), and the perceived quality of information. Adverse effects were defined as a higher EPIC score at follow-up than at baseline. The majority (77%) rated the general information as good. Higher EPIC-CP at follow-up was significantly associated with lower perceived quality of information, also after adjustment for age and level of education (bivariate model OR 1.12, 95% CI 1.07; 1.16, p < 0.001 and multiple model OR 1.12 95% CI 1.08; 1.17, p < 0.001). The share who rated information as good was almost identical among those who reported more symptoms after treatment and those who reported less symptoms (78.3% and 79.2%). Consequently, adverse effects could not explain the results. Our findings suggest a need for improvement of preoperative communication.

Creation and validation of the harmonized Arabic version of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

ABSTRACT Objectives Tocreate and validate a translated Arabic version of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), a validated patient-reported outcome (PRO) widely used for assessing the quality of life in patients with prostate cancer (PCa). Patients and Methods Using the established protocol as defined by the Professional Society for the Health Economics and Outcomes Research (ISPOR) for translating patient care questionnaires, a harmonised translated Arabic version of EPIC-CP was created. The questionnaire was tested in native Arabic speakers from four different Arabic countries (Saudi Arabia, United Arab Emirates, Jordan, and Kuwait). Cronbach’s alpha and interclass coefficient correlation (ICC) analyses were used to test the internal consistency and test–retest reliability, respectively. In addition, PCa characteristics were collected for participants. Results In total, 168 patients with PCa participated in the study (39 from Saudi Arabia, 23 from United Arab Emirates, 65 from Jordan, and 41 from Kuwait). In all, 52 (31%) participants repeated the questionnaire for test–retest reliability analysis. The median (interquartile range [IQR]) age of patients included in the study was 66 (61–71) years. The median (IQR) PSA level was 9.8 (6–19) ng/mL. Most patients had Grade Group 2 PCa at diagnosis (31%), clinical stage cT1 (42%), managed primarily by urology (79%), and the primary treatment was radical prostatectomy (71%). The total Cronbach’s alpha coefficient was 0.84 demonstrating an acceptable internal consistency. The total ICC was also acceptable at 0.64. Conclusion The Arabic version of the EPIC-CP is a reliable and valid tool for assessing health-related quality of life for Arabic patients with PCa.

Toxicity Outcomes After Low-Dose-Rate vs. High-Dose-Rate Brachytherapy Boost in Combination With External Beam Radiation for Intermediate and High-Risk Prostate Cancer

The addition of a brachytherapy boost to external beam radiation therapy (EBRT) reduces prostate cancer (PCa) recurrence compared with dose-escalated EBRT alone. However, combination therapy is associated with worse genitourinary (GU) toxicity compared with EBRT monotherapy. Whether brachytherapy boost technique, specifically low-dose-rate (LDR-BT) versus high-dose-rate (HDR-BT), impacts treatment-related toxicity is unclear and the subject of this analysis.This single institutional cohort study included 104 adult men with intermediate/high risk PCa treated with combination EBRT plus brachytherapy boost, with either LDR-BT or HDR-BT, between 2012 and 2018. Patient-reported outcomes (PRO) were assessed by the International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) surveys at 3-6-month intervals for up to three years following treatment, with higher scores indicating more severe toxicity. Provider-reported GU and gastrointestinal (GI) toxicities were assessed and graded per CTCAE V5.0 at each follow-up. Linear mixed models comparing PROs between LDR-BT versus HDR-BT were fitted. Stepwise multivariable analysis (MVA) was performed to account for age, gland size, androgen deprivation therapy (ADT) use, and alpha-blocker medication use. Incidence rates of grade 2+ GU/GI toxicity was compared using Chi-square test or Fisher's exact test.The median complete follow up time for LDR-BT and HDR-BT cohorts was 17 and 18.4 months, respectively. There was no difference in alpha-blocker use at baseline between groups (P = 0.16). Median prostate gland size was larger in the HDR-BT cohort compared with the LDR-BT cohort (39.99cc vs 26.58cc for HDR-BT vs LDR-BT, respectively; P < 0.001). The use of LDR-BT was associated with a greater change in IPSS (P = 0.003) and EPIC-CP urinary irritative score (P = 0.002) compared with HDR-BT, but effect size diminished over time (LDR-BT versus HDR-BT: baseline to 6-/24-month mean IPSS change, +6.4/+1.4 versus +2.7/-3.0, respectively; mean EPIC-CP irritative/obstructive change, +2.5/+0.1 versus +0.9/+0.1, respectively). These results remained significant on MVA. Incidence of post-treatment grade 2+ GU toxicity was significantly higher in the LDR-BT group (77.5% versus 42.9% for LDR-BT and HDR-BT, respectively; P < 0.001). There were no significant differences between LDR-BT and HDR-BT in EPIC-CP (total, urinary incontinence, bowel function, sexual, vitality) or provider-reported grade 2+ GI toxicity.In this single institution cohort, HDR-BT was associated with lower patient- and provider-reported GU toxicity compared with LDR-BT. However, differences in patient-reported toxicity diminished by 24 months post-treatment.

Randomized Trial of Conventional vs Conventional Plus Fluciclovine (18F) PET/CT-Guided Post-Prostatectomy Radiotherapy for Prostate Cancer: Volumetric and Patient-Reported Toxicity Analyses

<h3>Purpose/Objective(s)</h3> In recurrent post-prostatectomy prostate cancer pts, radiotherapy (XRT) planning with fluciclovine (18F) PET/CT (PET) has demonstrated improved disease-free survival without increase in provider-reported toxicity over conventional-only [CT or MRI-based] treatment planning. We hypothesized that incorporating PET would result in larger clinical target volumes (CTV's) without increasing patient-reported toxicities. <h3>Materials/Methods</h3> From 2012-2019, 165 post-prostatectomy pts with detectable PSA were randomized (Arm 1 [no PET]: 82; Arm 2 [PET]: 83). Prostate bed target volumes with (CTV1 [45.0-50.4 Gy/1.8 Gy]) or without (CTV2/CTV [64.8-70.2 Gy/1.8 Gy]) pelvic nodal treatment, as well as organ-at-risk dose endpoints, were compared pre- v post-PET (Arm 2 only) using the paired t-test and between Arms using the t-test. V40 Gy & V65 Gy rectum, bladder(-CTV) & penile bulb constraints were identical in all cases. Patient-reported outcomes (PRO's) utilized International Prostate Symptom Score (IPSS) & Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) metrics. Linear mixed-models (LMMs) incorporating PRO changes over time were fitted comparing the Arms. Univariate & multivariable analyses (MVA) were performed including demographic, disease, and treatment factors. <h3>Results</h3> Median FU of the whole cohort was 3.52 years. Though all pts had baseline PRO's, 1 pt in Arm 1 & 3 pts in Arm 2 withdrew, & 4 Arm 2 pts had extra-pelvic uptake on PET with XRT aborted, leaving 81 [Arm 1] & 76 pts [Arm 2] for toxicity analysis {1 Arm 2 pt unable to receive PET was not included in volumetric analysis but was included in toxicity analysis}. Mean CTV1 (427.63cc v 452.21cc [<i>P</i> = 0.462], Arm 1 v Arm 2) and CTV2/CTV (137.18cc v 134.20cc [<i>P</i> = 0.669]) were similar prior to PET incorporation. CTV1 (454.57cc v 461.33cc; <i>P</i> = 0.003) and CTV2/CTV (134.14cc v 135.61cc; <i>P</i> < 0.001) were significantly larger following PET incorporation. While V40 Gy (<i>P</i> = 0.402 & <i>P</i> = 0.522 for rectum & bladder, respectively) & V65 Gy (<i>P</i> = 0.157 & <i>P</i> = 0.182 for rectum & bladder, respectively) were not significantly different pre- v post-PET, penile bulb dose did significantly increase post-PET (<i>P</i> < 0.001 for both V40 Gy & V65 Gy). There was no significant difference in IPSS or EPIC-CP scores at baseline or beyond 18 mo between Arms. On MVA, Arm was not significant for any of the EPIC-CP subdomain scores [incontinence (<i>P</i> = 0.630), irritative (<i>P</i> = 0.076), sexual (<i>P</i> = 0.166), bowel (<i>P</i> = 0.402), vitality (<i>P</i> = 0.403)]. With LMMs there was no significant difference between Arms in IPSS (<i>P</i> = 0.276) or EPIC-CP (<i>P</i> = 0.209) scores over time. <h3>Conclusion</h3> Despite larger clinical target volumes after incorporation of fluciclovine (18F) PET into post-prostatectomy XRT treatment planning, we found no significant difference in patient-reported toxicities with long-term follow-up.

Exploring the role of digital health coaching for men with prostate cancer.

TPS1586 Background: Toxicity leading to impaired quality of life is common among men receiving treatment for Prostate Cancer (PCa). Digital interventions may be beneficial in enhancing health self-efficacy in managing symptom burden. This study evaluates the feasibility and preliminary outcomes of digital health coaching intervention on men with PCa. Methods: This pilot study aims to recruit up to 100 adult, English-speaking men with PCa who in the last 2 years have required active treatment, defined as cancer management via active surveillance, surgery, radiation, androgen deprivation, chemotherapy, hormonal therapy, immunotherapy or a combination of these modalities. Men will be enrolled across the catchment area of Jefferson Health using social media and a variety of other outreach tools approved by the Institutional Review Board. Consented patients are enrolled in a 3-month digital health coaching program which combines weekly calls with up to 4 nudges of evidence-based content delivered via text or email weekly. The program focuses on a weekly health topic, such as physical, mental, social, or financial health, and managing symptoms, and empowers participants to set health goals of importance to them. Primary endpoints include feasibility, defined as 60% of participants completing the 3-month program. The main secondary endpoints measured are health self-efficacy as measured by the Cancer Behavior Inventory-Brief (CBI-B), quality of life, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), financial toxicity as measured by the Comprehensive Score of Financial Toxicity (COST) and physical and mental health as measured by the Patient Reported Outcomes Measurement Information System-Global Health 10 (PROMIS-10). Outcomes are captured on enrollment and monthly through program completion for a total of 4 data points. Summary statistics will be used to describe patient demographic and clinical characteristics of the study population. Summary statistics will also be used to describe CBI, EPIC-CP, PROMIS and COST by assessment time. The change in CBI-B scores from baseline to 3 months will be calculated along with 95% confidence intervals. Additional LMMs will be created to assess the relationship between self-efficacy (CBI) and quality of life (EPIC-CP), financial toxicity (COST) and global health (PROMIS- SF10).

Translation and Linguistic Validation of Korean Version of the Expanded Prostate Cancer Index Composite for Clinical Practice for Patients With Prostate Cancer.

PurposeAdvances in the diagnosis and treatment of prostate cancer have increased the patients’ stress level and decreased the quality of life. A variety of instruments are currently available to evaluate patients with prostate cancer. However, only a few tools are available to assess Korean patients, and therefore we demonstrated a linguistic validation of Korean Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP).MethodsEPIC-CP was translated into Korean and the linguistic validation was evaluated. The evaluation process includes permission for translation, forward translation, reconciliation, backward translation, cognitive debriefing, and proofreading. Two bilingual translators independently translated the original questionnaire, discussed the feasibility and naturalness of initial translation, followed by revision to the reconciled version. Another translator then performed a backward translation into English. Ten patients with prostate cancer completed the translated questionnaire and performed cognitive debriefing.ResultsThe original EPIC-CP was translated into 2 Korean versions. The different wording in both versions and the ordinary words in the initial translations were changed considering the nuances and meanings of medical terms. During the backward translation, the panels made slight changes to clarify the meaning and nuances of the translated questionnaire. During cognitive debriefing, 10 patients answered the questionnaire and offered their opinions regarding comprehensibility and naturalness. Most patients agreed that the translation was comprehensible in general.ConclusionsOur study provides a successful linguistic validation of the EPIC-CP questionnaire. The translation is a helpful diagnostic tool to ensure the quality of life of patients with prostate cancer attending crowded clinics.

Evaluating the correlation between early and late quality-of-life declines using the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) after definitive stereotactic body radiotherapy, intensity-modulated radiotherapy, or brachytherapy for prostate cancer.

214 Background: Multiple authorities including an NCI Taskforce have recommended routine evaluation of patient reported outcomes (PRO) in cancer care. The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) is a single-page quality-of-life (QOL) tool which is easily integrated into routine clinical practice. The EPIC-CP has 5 domains (each scored 0-12). The present study evaluated whether early clinically significant changes in EPIC-CP were correlated with later changes in patients undergoing definitive radiotherapy (RT) for prostate cancer. Methods: A cohort of 979 patients including the PROSTQA study and 3 other institutions with prospective QOL data pooled for analysis were evaluated for patient-reported outcomes. Patients were treated with definitive low-dose rate brachytherapy (n=284), intensity-modulated RT (n=251), or stereotactic body RT (n=444). EPIC-CP scores were derived based upon responses to the EPIC-26. Data were evaluated using minimal clinically important difference (MCID) thresholds to compare QOL at 1-2 months and 24 months from baseline. Univariate analysis was used to assess the correlation between early and late MCID changes. Results: On univariate analysis, early ≥1 MCID change from baseline was strongly associated with a late ≥1 MCID across all 5 domains (urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal) within EPIC-CP and for the overall EPIC-CP score (Table). When MCID was instead defined as 1 or 3, early toxicity remained predictive of late toxicity for all domains and the overall EPIC-CP score. Conclusions: The EPIC-CP is an easy-to-use QOL assessment with clinically relevant outcomes. Early QOL decline was strongly associated with late QOL decline in patients undergoing definitive RT for prostate cancer across all EPIC-CP domains. Patients with early QOL decline may be candidates for early QOL-based interventions to alleviate their late toxicity burden from treatment. [Table: see text]

Portuguese version of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP): psychometric validation and prospective application for early functional outcomes at a single institution

BackgroundThe Expanded Prostate Index Composite for Clinical Practice (EPIC-CP) is a short version of the original EPIC, developed to facilitate the instrument’s use in routine care. This study aimed to validate the EPIC-CP Portuguese version, and evaluate its role in presenting early functional outcomes of surgically treated prostate cancer patients at a Latin American referral center.MethodsThe EPIC-CP was self-administered prospectively and individually by all localized prostate cancer patients, before and after robotic-assisted radical prostatectomy, from March 2017 to June 2018 at a single institution. For validation, we used the Cronbach’s alpha coefficient to evaluate internal consistency. The EPIC-CP domains were compared before surgery, and 6 months and 12 months after surgery. Statistical analyses were performed using the student’s t test, and Wilcoxon and Friedman tests, with p values < 0.05 considered significant.ResultsOne hundred and fifty two patients answered the EPIC-CP. The patients had a median age of 62.7 (± 8.5) years and prostate specific antigen level of 6.3 (± 4.6) ng/ml. The Cronbach’s alpha varied from 0.75 to 0.77 for all domains with good internal consistency, except for the “vitality/hormonal” domain, which had a score of 0.35. The domain evolution for the preoperative and 6-month postoperative groups revealed that the domains related to urinary continence and bowel worsened, and were increased during the first 6 months; however, this variation had no obvious clinical implications, and the irritative symptoms improved. Regarding the sexual domain, the scores worsened, and also increased over the first 6 months. The results of the confirmatory factor analysis were robust, with an explained variance of 0.951 and covariance of 0.929.ConclusionsThe Portuguese version of the EPIC-CP is a reliable and valid questionnaire for postoperative patients, and very useful to improve the knowledge of the early functional outcomes of men treated for prostate cancer.