Expanded Prostate Cancer Index Research Articles

Impact of Hypofractionated Radiotherapy on Patient-reported Outcomes in Prostate Cancer: Results up to 5 yr in the CHHiP trial (CRUK/06/016)

BackgroundModerate hypofractionation is the recommended standard of care for localised prostate cancer following the results of trials including Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy in Prostate Cancer (CHHiP). Evaluation of long-term patient-reported outcomes (PROs) is important to confirm safety and enhance patient information. ObjectiveTo determine whether 5-yr PROs from the CHHiP quality of life (QoL) substudy confirm 2-yr findings and assess patterns over follow-up. Design, setting, and participantsA phase III randomised controlled trial recruited from 2002 to 2011. The QoL substudy completed accrual in 2009; participants were followed up to 5 yr after radiotherapy. Analyses used data snapshot taken on August 26, 2016. A total of 71 radiotherapy centres were included in the study (UK, Republic of Ireland, Switzerland, and New Zealand); all 57 UK centres participated in the QoL substudy. CHHiP recruited 3216 men with localised prostate cancer (cT1b-T3aN0M0). InterventionConventional (74 Gy/37 fractions/7.4 wk) or hypofractionated radiotherapy (60 Gy/20 fractions/4 wk or 57 Gy/19 fractions/3.8 wk) was delivered with intensity-modulated techniques. Outcome measurements and statistical analysisUniversity of California Los Angeles Prostate Cancer Index, Short Form 36 and Functional Assessment of Cancer Therapy—Prostate, or Expanded Prostate Cancer Index Composite and Short Form 12 questionnaires were administered at baseline, before radiotherapy, at 10 wk, and at 6, 12, 18, 24, 36, 48, and 60 mo after radiotherapy. The QoL primary endpoint was overall bowel bother. Results and limitationsThe QoL substudy recruited 2100 patients; 1141 5-yr forms were available from 1957 patients still alive (58%). There were no statistically significant differences in 5-yr prevalence of overall “moderate or big” bowel bother: 19/349 (5.4%), 29/381 (7.6%), and 21/393 (5.3%) for 74, 60, and 57 Gy, respectively; overall urinary or sexual bother at 5 yr was similar between schedules. Bowel and urinary symptoms remained stable from 2 to 5 yr for all schedules. Some evidence of worsening overall sexual bother from baseline to 5 yr was less likely in the hypofractionated schedules compared with 74 Gy (odds ratios for increase in bother score vs 74 Gy: 0.55 [0.30–0.99], p = 0.009 for 60 Gy, and 0.52 [0.29–0.94], p = 0.004 for 57 Gy). General QoL scores were similar between schedules at 5 yr. ConclusionsLonger follow-up confirms earlier findings, with similar patient-reported bowel, urinary, and sexual problems between schedules overall. The continued low incidence of moderate or high bother confirms that moderate hypofractionation should be the standard of care for intermediate-risk localised prostate cancer. Patient summaryWe looked at patient-reported outcomes up to 5 yr after treatment in a trial of different radiotherapy schedules for prostate cancer. The findings confirmed that shorter radiotherapy schedules were as safe as standard radiotherapy in terms of bowel, urinary, and sexual problems. Take Home MessageBowel, urinary, and sexual symptoms were similar between schedules up to 5 yr. The continued low incidence of moderate/high bother confirms that moderate hypofractionated radiotherapy should be considered the standard of care for men with intermediate-risk prostate cancer.

PD08-02 NEOADJUVANT STEREOTACTIC BODY RADIOTHERAPY (SBRT) PRIOR TO RADICAL PROSTATECTOMY (RP) IN LOCALLY ADVANCED PROSTATE CANCER: A PHASE I TRIAL

PD08-02 NEOADJUVANT STEREOTACTIC BODY RADIOTHERAPY (SBRT) PRIOR TO RADICAL PROSTATECTOMY (RP) IN LOCALLY ADVANCED PROSTATE CANCER: A PHASE I TRIAL

MP36-08 PRE-PROCEDURAL LOW IIEF-5 AND TREATMENT OF PZ WITH ADJACENT NVB AND THE EJACULATORY DUCT WERE ASSOCIATED WITH SEXUAL DYSFUNCTION AFTER FOCAL THERAPY WITH HIGH-INTENSITY FOCUSED ULTRASOUND: A MULTI-INSTITUTIONAL PROSPECTIVE STUDY

You have accessJournal of UrologySexual Function/Dysfunction: Medical, Hormonal & Non-surgical Therapy II (MP36)1 Sep 2021MP36-08 PRE-PROCEDURAL LOW IIEF-5 AND TREATMENT OF PZ WITH ADJACENT NVB AND THE EJACULATORY DUCT WERE ASSOCIATED WITH SEXUAL DYSFUNCTION AFTER FOCAL THERAPY WITH HIGH-INTENSITY FOCUSED ULTRASOUND: A MULTI-INSTITUTIONAL PROSPECTIVE STUDY Sunao Shoji, Satoshi Kuroda, Kazuma Takeda, Takato Uchida, Soichiro Yuzuriha, Izumi Hanada, Takahiro Ogawa, Mayura Nakano, Masayoshi Kawakami, Masahiro Nitta, Masanori Hasegawa, Yoshiaki Kawamura, and Akira Miyajima Sunao ShojiSunao Shoji More articles by this author , Satoshi KurodaSatoshi Kuroda More articles by this author , Kazuma TakedaKazuma Takeda More articles by this author , Takato UchidaTakato Uchida More articles by this author , Soichiro YuzurihaSoichiro Yuzuriha More articles by this author , Izumi HanadaIzumi Hanada More articles by this author , Takahiro OgawaTakahiro Ogawa More articles by this author , Mayura NakanoMayura Nakano More articles by this author , Masayoshi KawakamiMasayoshi Kawakami More articles by this author , Masahiro NittaMasahiro Nitta More articles by this author , Masanori HasegawaMasanori Hasegawa More articles by this author , Yoshiaki KawamuraYoshiaki Kawamura More articles by this author , and Akira MiyajimaAkira Miyajima More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002045.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We aimed to analyze clinical factors related to sexual function in patients with localized prostate cancer (PC) who were treated with focal therapy with high-intensity focused ultrasound (HIFU). METHODS: From 2016 to 2020, patients with localized PC who had erectile and ejaculatory function before focal therapy with HIFU, were included prospectively. Sexual function was evaluated for 12 months for each treated area. Before and after treatment, International Index of Erectile Function-5 (IIEF-5), sexual domain of the Expanded Prostate Cancer Index Composite (EPIC), and Common Terminology Criteria for Adverse Events (CTCAE) v.5.0 classification of ejaculation were used to assess sexual function. Erectile dysfunction (ED) and ejaculatory dysfunction (EjD) were defined as IIEF-5 score ≤7 and CTCAE grade 2. RESULTS: This study included 92 patients with median age 66 years, median IIEF-5: 16, and median sexual domain of EPIC: 55. Clinical T stages were T2a: n=54, T2b: n=17, and T2c: n=21. The rates of ED and EjD were 24% and 36%, respectively, at 12 months after treatment. Significant differences were observed between patients with preserved erectile function and those with ED in terms of clinical T stage (p=0.004), pre-procedural IIEF-5 (p=0.002), sexual domain of EPIC before treatment (p=0.011), and treatment of peripheral zone (PZ) with adjacent neurovascular bundle (NVB) (none vs. one side vs. both sides; p=0.017). In multivariate logistic regression analyses, pre-procedural score of 8-11 in IIEF-5 (OR 0.785; p=0.002) and treatment of PZ with adjacent NVB (OR 6.291; p=0.008) were significant risk factors for ED after treatment. Significant differences were observed between patients with preserved ejaculation and those with EjD in terms of pre-procedural IIEF-5 (p<0.0001), sexual domain of EPIC before treatment (p=0.002), and treatment of PZ with adjacent NVB (p=0.007) and ejaculatory duct (none vs. unilateral vs. bilateral; p<0.0001). In multivariate logistic regression analyses, pre-procedural score of 8-11 in IIEF-5 (OR 0.768; p<0.0001) and treatment range including the ejaculatory duct (OR 25.565; p=0.002) were significant risk factors for EjD after treatment. CONCLUSIONS: A greater risk of ED was associated with pre-procedural low IIEF-5 and treatment of PZ with adjacent NVB, and a greater risk of EjD was associated with pre-procedural low IIEF-5 and treatment of the ejaculatory duct after focal therapy with HIFU. Source of Funding: None. © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e638-e639 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sunao Shoji More articles by this author Satoshi Kuroda More articles by this author Kazuma Takeda More articles by this author Takato Uchida More articles by this author Soichiro Yuzuriha More articles by this author Izumi Hanada More articles by this author Takahiro Ogawa More articles by this author Mayura Nakano More articles by this author Masayoshi Kawakami More articles by this author Masahiro Nitta More articles by this author Masanori Hasegawa More articles by this author Yoshiaki Kawamura More articles by this author Akira Miyajima More articles by this author Expand All Advertisement Loading ...

MP64-20 PREOPERATIVE MEMBRANOUS URETHRAL LENGTH IS ASSOCIATED WITH POST-PROSTATECTOMY URINARY FUNCTION IN ASIAN MEN

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy VI (MP64)1 Sep 2021MP64-20 PREOPERATIVE MEMBRANOUS URETHRAL LENGTH IS ASSOCIATED WITH POST-PROSTATECTOMY URINARY FUNCTION IN ASIAN MEN Spyridon Basourakos, Ashwin Ramaswamy, Miko Yu, Daniel Margolis, and Jim Hu Spyridon BasourakosSpyridon Basourakos More articles by this author , Ashwin RamaswamyAshwin Ramaswamy More articles by this author , Miko YuMiko Yu More articles by this author , Daniel MargolisDaniel Margolis More articles by this author , and Jim HuJim Hu More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002104.20AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Studies demonstrate that Asian and African-American race (vs. white) and preoperative membranous urethral length (MUL) measured on MRI have been associated with post-radical prostatectomy (RP) urinary incontinence. However, the relationship of race and MUL has not been studied: this is noteworthy given improved patient selection as an approach to minimize the risk of post-RP incontinence. METHODS: We retrospectively identified men who self-identified as “Asian” and underwent robot-assisted RP for localized prostate cancer between 2015 and 2020. After appropriate training of two readers by an expert genitourinary radiologist, MULs were blindly measured by the two readers independently. Urinary function was assessed using the Expanded Prostate Cancer Index for Clinical Practice (EPIC-CP). Baseline clinicopathologic characteristic and imaging measurements were compared with Wilcoxon-Mann-Whitney and χ2 test. We used a generalized estimating equation (GEE) model to evaluate if Asian race is associated with urinary function recovery. RESULTS: There were no racial differences by age (66.8 95%CI 64.7-69.0 vs. 65.6, 95%CI 62.6-68.6; p=0.6), BMI (25.9, 95%CI 24.7-27.2 vs. 26.7, 95%CI 25.7-27.8; p=0.3), PSA (10.3, 95%CI 7.6-12.9 vs. 8.6, 95%CI 6.3-11.0; p=0.4), prostate volume (50.4, 95%CI 37.8-63.0 vs. 41.5, 95%CI 25.9-46.7; p=0.2) or complete nerve sparing status (86% vs. 86%; p=1.0). Asian men had shorter MUL (7.9mm, 95%CI 7.5–8.3 vs. 10.9mm, 95%CI 10.2–11.7; p<0.01) and worse EPIC-CP urinary function scores (3.82; 95%CI 2.47-5.17 vs. 1.95; 95%CI 1.11–2.79; p=0.022) at 12 months post-RP compared to non-Asians. Our GEE model demonstrated that Asian race is associated of a higher (worse) EPIC-CP urinary score when compared to non-Asians (parameter estimate 0.56; 95%CI 0.04-1.08; p=0.034). Furthermore, we found that lower MUL (p=0.03) and Asian race (p=0.036) were associated with increased 12-month EPIC-CP urinary function scores in a multivariate logistic model that included age and BMI. CONCLUSIONS: Asian race was associated with shorter MUL, and both Asian race and shorter MUL are independently associated with worse urinary function. Further confirmatory studies and comparative racial studies of MUL are necessary to better characterize disparities in outcomes. Source of Funding: Jim C. Hu receives research support from the Frederick J. and Theresa Dow Wallace Fund of the New York Community Trust. Jim C. Hu also receives salary support from NIH R01 CA241758 and PCORI CER-2019C1-15682. The remaining authors report no further disclosures related to this work © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1118-e1118 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Spyridon Basourakos More articles by this author Ashwin Ramaswamy More articles by this author Miko Yu More articles by this author Daniel Margolis More articles by this author Jim Hu More articles by this author Expand All Advertisement Loading ...

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 ...

First results of active observation of patients with prostate cancer and low oncological risk

The study objective is to improve results of treatment of patients with prostate cancer (PC) and low oncological risk.Materials and methods. Since November of 2019 at the Institute of Urology and Human Reproductive Health of the I.M. Sechenov First Moscow State Medical University 40 patients with PC and low oncological risk were included in the protocol of active observation. In all patients, the level of prostate-specific antigen was evaluated every 3 months, digital rectal examination was performed every 6 months, magnetic resonance tomography of the pelvis with intravenous contrast was performed every 12 months. Confirming biopsy of the prostate was performed once, 1 year after the beginning of observation. Every 6 months patients' quality of life was evaluated using the SF-36 (Short Form 36 Health Quality Survey), IIEF-5 (International Index of Erectile Function), IPSS (International Prostate Symptom Score), EPIC-26 (Expanded Prostate Cancer Index Composite) questionnaires.Results. Two (5 %) patients underwent surgical treatment due to PC progression. One (2.5 %) patient preferred treatment due to oncological anxiety. Mean value per the SF-36 questionnaire at the beginning of the study was 63.2 ± 11.5 for psychological component of health and 57.1 ± 9.8 for physical component of health. At the moment, the assessment of the psychological and physical components of health according to SF-36 is 69.5 ± 12.4 and 66.3 ± 8.9 points, respectively. Mean IIEF-5 value at the beginning of the study was 18.8 ± 4.2, currently it is 18.6 ± 3.9. At the beginning of the study mean IPSS value was 9.1 ± 2.1, currently it is 9.4 ± 1.9. For the EPIC-26 questionnaire mean value for all criteria initially was 56.1 ± 5.1, currently it is 68.2 ± 4.6.Conclusion. First results of active observation of patients with PC and low oncological risk demonstrated that this approach allows to avoid unnecessary treatment of patients who do not require immediate intervention and to start treatment on time in cases where it is required while preserving high quality of life for the patients.

Patient-reported outcomes after Low-dose-rate versus High-dose-rate brachytherapy boost in combination with external beam radiation for intermediate and high risk prostate cancer

PURPOSEAddition of a brachytherapy boost to external beam radiation therapy (EBRT) reduces prostate cancer (PCa) recurrence at the expense of genitourinary (GU) toxicity. Whether brachytherapy boost technique, specifically low-dose-rate (LDR-BT) versus high-dose-rate (HDR-BT), impacts treatment-related toxicity is unclear. METHODSBetween 2012-2018, 106 men with intermediate/high risk PCa underwent EBRT (37.5-45 Gy in 1.8-2.5 Gy/fraction) plus brachytherapy boost, either with LDR-BT (110 Gy I-125 or 100 Gy Pd-103; n = 51) or HDR-BT (15 Gy x1 Ir-192; n = 55). Patient-reported outcomes (PRO) were assessed by International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite (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) toxicity was 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 use, and alpha-blocker medication use. Incidence rates of grade 2+ GU/GI toxicity was compared using Fisher's exact test. RESULTSUse of LDR-BT was associated with 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). Results remained significant on MVA. Post-treatment grade 2+ GU toxicity was significantly higher in the LDR-BT group (67.5% versus 42.9% for LDR-BT and HDR-BT, respectively; p <0.001). There were no differences between groups in incontinence, bowel function, and erectile function, or grade 2+ GI toxicity. CONCLUSIONCompared with LDR-BT, HDR-BT was associated with lower acute patient- and provider-reported GU toxicity.

Health-Related Quality of Life and Toxicity After Definitive High-Dose-Rate Brachytherapy Among Veterans With Prostate Cancer.

High-dose-rate (HDR) brachytherapy (BT) is a well-tolerated and effective treatment for prostate cancer. There is limited research, however, investigating toxicity outcomes with HDRBT treatment among veterans. The objective of this study is to assess the impact on health-related quality of life (hrQOL) and physician-graded toxicities associated with HDRBT as monotherapy among veterans treated at Edward Hines, Jr. Veterans Affairs Hospital in Hines, Illinois. Between 2016 and 2019, 74 veterans with low- or intermediate-risk prostate cancer were treated with HDRBT as monotherapy with 27 Gy in 2 fractions, delivered over 2 implants. Veteran-reported hrQOL in the genitourinary (GU), gastrointestinal (GI), and sexual domains was assessed using the International Prostate Symptoms Score (IPSS) and Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. Mixed linear effect models were used to assess differences in the hrQOL scores at follow-up compared with baseline scores. Statistically significant differences in hrQOL scores from baseline were further assessed for clinical significance, using minimal clinically important difference (MCID) evaluations. Median follow-up was 18 months. Veterans reported declines in GU, GI, and sexual hrQOL scores immediately after treatment, with the IPSS and EPIC-26 hrQOL scores all displaying significant decrease from baseline over time. The majority of the declines in hrQOL scores met criteria for MCID. These hrQOL scores trended toward a return to baseline, with the EPIC-26 urinary obstruction score returning to baseline at the 18-month follow-up assessment and the EPIC-26 bowel score returning to baseline at the 12-month follow-up. The IPSS, urinary incontinence, and sexual scores did not return to baseline at 18 months. The grade 2 maximum physician-graded GU, GI, and sexual toxicity rates were 65%, 5%, and 53%, respectively. There was 1 incidence of grade 3 GU toxicity but no grade 3 GI or sexual toxicity. HDRBT as monotherapy is a well-tolerated treatment option for veterans with low- or intermediate-risk prostate cancer, with favorable veteran-reported and physician-graded toxicities. Veterans should be educated about HDRBT as an option when counseled regarding treatment for localized prostate cancer.

Changes In Anxiety, Fear Of Cancer Progression, And Quality Of Life In Prostate Cancer Patients On Active Surveillance After A 12-week Exercise Program: A Randomized Controlled Trial

PURPOSE: Prostate cancer (PCa) patients undergoing active surveillance often experience psychological distress such as anxiety or fear or cancer progression. This study was to investigate the impacts of a 12-week exercise program on patient-reported outcomes in PCa patients undergoing active surveillance. METHODS: 52 PCa patients on active surveillance were randomized to high-intensity interval training (HIIT; n = 26) or usual care (UC; n = 26). The HIIT group performed a 12-week, thrice-weekly, supervised, aerobic HIIT intervention. Patient-reported outcomes were assessed at baseline and postintervention (12-weeks), including PCa-specific anxiety (Memorial Anxiety Scale for Prostate Cancer; MAX-PC), fear of cancer progression (Fear of Cancer Recurrence Inventory; FCRI), PCa-related symptoms (Expanded Prostate Cancer Index Composite-26; EPIC-26), cancer-related quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item; EORTC QLQ-C30), and generic psychosocial outcomes (e.g., fatigue, stress, and self-esteem). Analysis of covariance was used to compare between-group differences. RESULTS: 50/52 (96%) participants completed patient-reported outcome assessments at 12-weeks and adherence to the HIIT program was 96%. Compared to UC, HIIT significantly reduced total PCa-specific anxiety (adjusted between-group mean difference, -2.7; 95% confidence interval[CI], -5.0 to -0.4; p = 0.024; d = 0.28) and fear of recurrence (adjusted between-group mean difference, -2.0; 95% CI, -3.5 to -0.4; p = 0.013; d = 0.67) in MAX-PC; hormonal dysfunction (p = 0.005) in EPIC-26; and perceived stress (p = 0.037), fatigue (p = 0.029), and self-esteem (p = 0.007). CONCLUSIONS: A 12-week supervised HIIT program reduced PCa-specific anxiety, fear of cancer progression, hormone symptoms, stress, and fatigue, and increased self-esteem in men with PCa on active surveillance. Larger trials are warranted to determine the longer-term effects of exercise on patient-reported outcomes and whether such effects influence willingness to continue on active surveillance.

The expanded prostate cancer index composite short form (EPIC-26) for measuring health-related quality of life: content analysis of patients\u2019 spontaneous comments written in survey margins

IntroductionThis study investigates comments that prostate cancer patients spontaneously write in the margins of the Expanded Prostate Cancer Index Short Form (EPIC-26) questionnaire. We aim to show the possible barriers that patients face while answering the survey, and to consider how these barriers may affect the response data generated. We investigate the kind of information patients’ comments on EPIC-26 contain, and patients’ motivations to provide this information. We also study why some EPIC domains spark more comments than others.MethodWe analyzed 28 pages of transcribed comments and four pages of supplementary letters from our survey participants (n = 496). Using inductive content analysis, we generated 10 categories describing the content of participants’ comments, and four themes demonstrating their motives for commenting. The comments regarding each EPIC domain were quantified to discover any differences between domains.ResultsThe sexual domain of EPIC-26 provoked over half of all comments. Patients without recent sexual activity or desire had difficulties answering sexual function questions 8–10. The lack of instructions on whether to take erectile aid use into account when answering erectile function questions led to a diversity of answering strategies. Patients with urinary catheters could not find suitable answer options for questions 1–4. All domains sparked comments containing additional information about experienced symptoms.ConclusionPatients are mainly willing to report their symptoms, but a lack of suitable answer options causes missing data and differing answering strategies in the sexual and urinary domains of EPIC-26, weakening the quality of the response data received.

Patient Reported Quality of Life Outcomes After Definitive Radiation Therapy With Absorbable Spacer Hydrogel for Prostate Cancer

PurposeSpaceOAR is a device approved for conventional radiation in prostate cancer. We sought to observe prospectively how SpaceOAR Hydrogel effected quality of life and dosimetry to organs at risk at our institution. Methods and MaterialsWe prospectively enrolled patients with low risk or favorable-intermediate risk localized prostate cancer. Baseline Expanded Prostate Cancer Index Composite (EPIC-26) scores along with baseline American Urology Association Symptom Index (AUA-SI) scores were collected. SpaceOAR was placed for all patients who then received stereotactic body radiation therapy, low dose rate brachytherapy, conventionally fractionated radiation therapy, or moderately hypofractionated radiation therapy. We evaluated postimplant dosimetry to critical structures, and prospectively collected follow-up EPIC-26 and AUA-SI scores. We performed a repeated measures analysis of variance to compare patient-specific responses and correlated survey data with dosimetric metrics by generating linear regression models. ResultsWe enrolled 59 patients in this study with a median follow-up of 366 days (interquartile range, 507). At final follow-up, the "?>prostate-specific antigen had a significant decline compared with baseline (P < .0001). There were no grade 3 toxicities on treatment. There were no significant changes in the AUA-SI score (P = .69) at final follow-up compared with baseline, nor was there any change in EPIC-26 domain scores (P = .19) during the course of the study period. There were no significant associations between AUA scores and EPIC-26 scores and the dose to the rectum, bladder, or urethra with the exception being dose to the 2 mL rectum correlated with decline in EPIC-26 rectal score (β, −0.002; P = .006). Patient-reported declines in bowel domains were less than previously reported data. ConclusionsUse of SpaceOAR results in favorable dosimetry to the organs at risk and portends excellent short-term quality of life as measured by the association with the patient reported outcome measures. Longer-term follow-up is ongoing and necessary to assess the long-term effect and association of the hydrogel.

Clipless Robotic-assisted Radical Prostatectomy and Impact on Outcomes

BackgroundThe use of surgical clips for athermal dissection of the lateral prostatic pedicles and ligation during pelvic lymph node dissection (PLND) while performing robotic-assisted radical prostatectomy (RARP) has been the gold standard. Clips are used to prevent thermal injury of the unmyelinated nerve fibers and lymphceles, respectively. ObjectiveTo compare oncological and functional outcomes of a new technique of clipless, lateral pedicle control and PLND with RARP with bipolar energy (RARP-bi) versus the standard RARP technique with clips (RARP-c). Design, setting, and participantsA retrospective study was conducted among 338 men who underwent RARP between July 2018 and March 2020. Surgical procedureRARP-c versus RARP-bi. MeasurementsWe prospectively collected data and retrospectively compared demographic, clinicopathological, and functional outcome data. Urinary as well as sexual function was assessed using the Expanded Prostate Cancer Index for Clinical Practice, and complications were assessed using Clavien-Dindo grading. Multivariable regression modeling was used to examine whether the technical approach of RARP-bi versus RARP-c was associated with positive surgical margins (PSMs) or sexual and urinary function scores. Results and limitationsA total of 144 (43%) and 194 (57%) men underwent RARP-bi and RARP-c, respectively. Overall, there were no differences in functional and oncological outcomes between the two approaches. On multivariable regression analysis, the RARP-bi technique was not associated with significant differences in PSMs (odds ratio [OR] = 1.04, 95% confidence interval [CI] 0.6–1.8; p = 0.9), sexual function (OR = 0.4, 95% CI 0.1–1.5; p = 0.8), or urinary function (OR = 0.5, 95% CI 0.2–1.4; p = 0.2). The overall 30-d complication rates (12% vs 16%, p = 0.5) and bladder neck contracture rates (2.1% vs 3.6%, p = 0.5) were similar between the two groups. There was no difference in lymphocele complications (1.4% vs 0.52%, p = 0.58). All complications were of Clavien-Dindo grade I–II. ConclusionsDespite the concerns for an increased risk of nerve injury secondary to the use of bipolar energy for prostatic pedicle dissection, we demonstrate that this technique is oncologically and functionally similar to the standard approach with surgical clips. There was no difference in complications or lymphocele formation for techniques with versus without clips. Patient summaryWe describe a modified technique for prostatic pedicle dissection during robotic-assisted radical prostatectomy, which utilizes bipolar energy and is associated with shorter operative time, without compromising functional or oncological outcomes.

Abstract 2528: Rurality and neighborhood socioeconomic deprivation associated with patient-reported outcomes andsurvivalin men with prostate cancer in NRG RTOG 0415

Abstract Background: Prostate cancer is the most common cancer among men. Monitoring of patient-reported outcomes (PROs) can enhance provider-patient communication, promote better decision-making, and improve survival. Geospatial factors, namely rurality and neighborhood socioeconomic deprivation, could influence the experience across cancer treatment, thus impacting PROs and survival. This study examined associations of rurality, neighborhood socioeconomic deprivation (Area Deprivation Index [ADI]) with cancer treatment-related PROs and survival in men with prostate cancer. Methods: Data from men with prostate cancer in the trial NRG Oncology/RTOG 0415 were analyzed. In this trial, 1092 men were randomized to receive conventional radiotherapy (RT) or hypofractionated RT. Patients had Gleason scores of 2-6 and prostate-specific antigen of &amp;lt;10 ng/mL. Rurality was categorized as urban vs rural using Rural-Urban Continuum Codes via patient zip codes. Neighborhood socioeconomic deprivation was assessed by the ADI calculated via the American Community Survey by patient zip codes. The Expanded Prostate Cancer Index Composite (EPIC) measures cancer-specific quality of life (QOL); Hopkins Symptom Checklist measures anxiety and depression; EuroQoL-5 Dimension (EQ-5D) VAS and Index scores assess general health. All PROs were measured at baseline before and 6, 12, 24 and 60 months after RT. Overall survival (OS) and disease-free survival (DFS) were assessed using Cox proportional hazards models. Mixed effects models and generalized estimating equations were used to analyze PROs. Results: We analyzed 751 patients with complete data. Patients from the ADI 25% most deprived neighborhoods (vs. the other 75% of neighborhoods) were more likely to be non-white, unmarried and from rural areas. At baseline, patients from the most deprived areas had worse EPIC bowel score (P=0.011), worse sexual score (P=0.042) and worse hormonal score (P=0.015); patients from the most deprived areas had worse self-care (P=0.04) and more pain (P=0.047). Patients from rural areas had worse EPIC urinary score (P=0.03) and sexual score (P=0.003). Longitudinal analyses showed that ADI 25% most deprived areas (β=4.05, P=0.001) and rural areas (β=-5.70, P=0.003) were associated with worse EQ-5D VAS score. Compared to the 75% less deprived neighborhoods and urban, the ADI 25% most deprived neighborhoods and rural areas respectively had 47% (HR=1.466, P=0.033) and 93% (HR=1.925, P=0.026) relative increase in risk of recurrence or death (DFS). No differences were seen in OS. Conclusions: Patients with prostate cancer from the most deprived neighborhoods and rural areas had low QOL at baseline, poor general health and DFS. Interventions should target populations from socioeconomic deprived neighborhoods and rural areas to improve patient access to supportive care services and DFS. Citation Format: Jinbing Bai, Stephanie L. Pugh, Ronald Eldridge, Katherine Yeager, Qi Zhang, W Robert Lee, Amit B. Shah, Ian S. Dayes, David P. D'Souza, Jeff M. Michalski, Jason A. Efstathiou, John M. Longo, Thomas M. Pisansky, Jordan M. Maier, Sergio L. Faria, Anand B. Desai, Samantha A. Seaward, Howard M. Sandler, Mary E. Cooley, Deborah W. Bruner. Rurality and neighborhood socioeconomic deprivation associated with patient-reported outcomes andsurvivalin men with prostate cancer in NRG RTOG 0415 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 2528.

Randomized-Controlled Trial Examining the Effect of Pelvic Floor Muscle Training in the Treatment of Stress Urinary Incontinence in Men after a Laparoscopic Radical Prostatectomy Pilot Study.

Aim: The aim of this study was to assess the impact of pelvic floor muscle training (PMFT) in the treatment of stress urinary incontinence (SUI) in men after they received radical prostatectomy (RP). Methods: From November 2018 to September 2019, patients who underwent radical prostatectomy were assessed for eligibility. A total of 37 men were then randomly assigned to the experimental group (EG) and the control group (CG). The EG group received supervised exercise twice a week for 12 weeks, and the CG did not receive any intervention. To objectify the results obtained in both groups before and after the intervention, the authors assessed myostatin concentration. Moreover, the Expanded Prostate Cancer Index Composite (EPIC-26) was applied to assess the quality of life, and Beck’s Depression Inventory (BDI-II) was used to measure depression severity. Results: Study results demonstrated a statistically significant reduction of myostatin concentration in the EG following the treatment and no statistically significant differences in this parameter in the CG. In addition, a comparison of the EPIC-26 scores in the EG at the initial and final assessments revealed a statistically significant improvement in the quality of life in each domain. A comparison of the EPIC-26 scores in the CG at the initial and final assessments showed there is a statistically significant decline in quality of life in the “overall urinary problem” and “sexual” domain. A comparison of the BDI-II scores at the initial and final assessments showed a statistically significant decline in depressive symptoms in the EG and no statistically significant differences in the CG. Conclusions: PFMT is an effective treatment for urinary incontinence (UI) in men who received radical prostatectomy.

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).

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.

One-year urinary and sexual outcome trajectories among prostate cancer patients treated by radical prostatectomy: a prospective study

BackgroundTo examine one-year trajectories of urinary and sexual outcomes, and correlates of these trajectories, among prostate cancer patients treated by radical prostatectomy (RP).MethodsStudy participants were recruited from 2011 to 2014 at two US institutions. Self-reported urinary and sexual outcomes were measured at baseline before surgery, and 5 weeks, 6 months and 12 months after surgery, using the modified Expanded Prostate Cancer Index Composite-50 (EPIC-50). Changes in EPIC-50 scores from baseline were categorized as improved (beyond baseline), maintained, or impaired (below baseline), using previously-reported minimum clinically important differences.ResultsOf the 426 eligible participants who completed the baseline survey, 395 provided data on at least one EPIC-50 sub-scale at 5 weeks and 12 months, and were analyzed. Although all mean EPIC-50 scores declined markedly 5 weeks after surgery and then recovered to near (incontinence-related outcomes) or below (sexual outcomes) baseline levels by 12 months post-surgery, some men experienced improvement beyond their baseline levels on each sub-scale (3.3–51% depending on the sub-scale). Having benign prostatic hyperplasia (BPH) at baseline (prostate size ≥ 40 g; an International Prostate Symptom Index Score ≥ 8; or using BPH medications) was associated with post-surgical improvements in voiding dysfunction-related bother at 5 weeks (OR = 3.9, 95% CI: 2.1–7.2) and 12 months (OR = 3.3, 95% CI: 2.0–5.7); and in sexual bother at 5 weeks (OR = 5.7, 95% CI:1.7–19.3) and 12 months (OR = 3.0, 95% CI: 1.2–7.1).ConclusionsOur findings provide additional support for considering baseline BPH symptoms when selecting the best therapy for early-stage prostate cancer.

Patterns of care for prostate cancer treatment and improving outcomes - are national registries the answer?

Patterns of care for prostate cancer treatment and improving outcomes - are national registries the answer?

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.

A prospective clinical and transcriptomic feasibility study of oral-only hormonal therapy with radiation for unfavorable prostate cancer in men 70 years of age and older or with comorbidity.

Androgen deprivation therapy (ADT) improves outcomes in unfavorable-risk prostate cancer (PCa) treated with radiation therapy (RT). It was hypothesized that replacing luteinizing hormone-releasing hormone (LHRH) agonists with a 5-α-reductase inhibitor (5-ARI) would improve hormonal health-related quality of life (HRQOL) without differentially suppressing androgen-responsive (AR) gene expression. Patients with localized unfavorable-risk PCa, aged ≥70 years or Charlson Comorbidity Index score ≥2 were treated with oral ADT (oADT), consisting of 4 months of bicalutamide, a 5-ARI, and RT at 78 Gy. The primary end point was Expanded Prostate Cancer Index Composite HRQOL at 6 months ≤30%, and improvement compared with a synchronous standard of care (SOC) cohort receiving 4 months of bicalutamide and long-term LHRH agonist with RT. RNA sequencing was performed from matched pre-/post-ADT prostate tumor biopsies in a subset of men. Differential gene and pathway expressional changes were examined using gene set enrichment. Between 2011 and 2018, 40 and 30 men were enrolled in the oADT and SOC cohorts, respectively. Median follow-up was 40 months. Those with ≤30% decline in hormonal HRQOL at 6 months was 97% (oADT) and 93% (SOC). The average 6-month hormonal decline was 1% (oADT) versus 12% (SOC; P = .04). The 4-year freedom from biochemical failure was 88% (oADT) versus 81% (SOC; P = .48). RNA sequencing (n = 9) showed similar numbers of downregulated and upregulated genes between the treatment groups (fold-change = 2; false-discovery rate-adjusted P ≤ .05). Both treatments comparably decreased the expression of 20 genes in canonical androgen receptor signaling. For men with PCa undergoing RT, oral versus standard ADT may improve 6-month QOL and appears to have a similar impact on androgen-responsive gene expression.