Expanded Prostate Index Composite Research Articles

Bothersome Hot Flashes Following Neoadjuvant Androgen Deprivation Therapy and Stereotactic Body Radiotherapy for Localized Prostate Cancer.

Androgen deprivation therapy (ADT) improves local cancer control in unfavorable localized prostate cancer treated with radiotherapy. ADT is known to cause hormonally related symptoms that resolve with testosterone recovery. Hot flashes are particularly burdensome. This study sought to evaluate the timeline of hot flashes following short-course ADT and stereotactic body radiotherapy (SBRT) as well as its relationship with testosterone recovery. Institutional IRB approval was obtained for this retrospective review of prospectively collected data (IRB#: 2009-510). ADT was initiated three months prior to the start of SBRT. Hot flashes were self-reported via question 13a of the Expanded Prostate Index Composite (EPIC)-26 prior to ADT initiation, the first day of robotic SBRT, and at each follow-up (one, three, six, nine, 12, 18, 24, and 36 months). The responses were grouped into three relevant categories (no problem, very small-small problem, and moderate-big problem). Scores were transformed to a 0-100 scale with higher scores reflecting less bother. Testosterone levels were measured at each follow-up. From 2007 to 2010, 122 localized prostate cancer patients (nine low-, 64 intermediate-, and 49 high-risk according to the D'Amico classification) at a median age of 72 years (range 54.5-88.3) were treated with short course ADT (three to six months) and SBRT (35-36.25 Gy) at Georgetown University Hospital. Thirty-two percent were Black and 27% were obese. Seventy-seven percent of patients received three months of ADT. At baseline, 2% of men experienced hot flashes that were a "moderate to big problem" and that proportion peaked at the start of SBRT (45%) before returning to baseline (2%) nine months post-SBRT with a cumulative incidence of 52.4%. The median baseline EPIC-26 hot flash score of 94 declined to 50 at the start of SBRT but this returned to baseline (92) by six months post SBRT. These changes were both statistically and clinically significant (MID = 9.5083, p<0.01). Testosterone recovery (> 230 ng/dL) occurred in approximately 70% of patients by 12 months post SBRT. Resolution of hot flashes correlated with testosterone recovery. Bothersome hot flashes occur in greater than 50% of men treated with neoadjuvant ADT. Resolution of hot flashes occurs in the majority of patients within one year after treatment. Reassurance of the temporary nature of hot flashes may assist in reducing patient anxiety. Measuring testosterone levels at follow-up visits may allow for anticipatory counseling that may limit the associated bother.

Testosterone as a Biomarker for Quality of Life (QOL) Following Androgen Deprivation Therapy (ADT) and Stereotactic Body Radiotherapy (SBRT).

Androgen deprivation therapy (ADT) causes fatigue and sexual dysfunction. The time to testosterone recovery depends on patient and treatment-specific characteristics. The kinetics of testosterone recovery in men treated with neoadjuvant ADT and stereotactic body radiotherapy (SBRT) is not well established. This study seeks to characterize testosterone recovery and evaluate its relationship with the improvement in patient-reported hormonal and sexual function. Institutional review board (IRB) approval was obtained for retrospective review of prospectively collected data. All patients with localized prostate cancer treated with short-course ADT (3-6 months of Leuprolide) and robotic SBRT (35-36.25 Gy in five fractions) at a single institution were included in this analysis.Testosterone levels were measured at the start of radiation, every 3 months for the first year, and every 6 months thereafter. Total testosterone recovery was defined as a serum level of >230 ng/dL. Sexual and hormonal function was recorded using the Expanded Prostate Index Composite (EPIC)-26 prior to ADT initiation, the first day of SBRT, and at each follow-up. The EPIC-26 subdomain scores were transformed to a 0-100 scale with higher scores reflecting less bother. Between January 2009 and May 2018, 122 men with a median age of 72 years (range: 55-89 years) received ADT followed by SBRT. Thirty-two percent(N=39) were black and 27% [N=39 were obese (BMI > 30)]. The median pre-SBRT testosterone level was 15 ng/dL (range: 3-89 ng/dL). Around 77% (N=94) of patients received 3 months of ADT. The median pre-ADT EPIC-26 Hormone and Sexual Domain Scores were 94 and 41, respectively. At 12 months, 71% (N=87) of patients recovered to a eugonadal state with a mean recovery time of 4 months post-SBRT. Hormonal and sexual subdomain scores declined significantly following ADT but recovered to within the minimally important difference (MID) for sexual and hormonal domain scores by 12 months post-SBRT. Testosterone recovery following short-course ADTwith leuprolide and SBRT occurs rapidly in the majority of patients within one year after treatment. Quality of life domain improvements followed the testosterone recovery trend closely. Testosterone testing at follow-up appointments would allow for anticipatory counseling that may limit the bother associated with temporary quality of life decrements.

A Contemporary Report of Low-Dose-Rate Brachytherapy for Prostate Cancer Using MRI for Risk Stratification: Disease Outcomes and Patient-Reported Quality of Life.

We examined a prospective consecutive cohort of low dose rate (LDR) brachytherapy for prostate cancer to evaluate the efficacy of monotherapy for unfavorable-intermediate risk (UIR) disease, and explore factors associated with toxicity and quality of life (QOL). 149 men with prostate cancer, including 114 staged with MRI, received Iodine-125 brachytherapy alone (144-145 Gy) or following external beam radiation therapy (110 Gy; EBRT). Patient-reported QOL was assessed by the Expanded Prostate Index Composite (EPIC) survey, and genitourinary (GU) and gastrointestinal (GI) toxicity were prospectively recorded (CTC v4.0). Global QOL scores were assessed for decline greater than the minimum clinically important difference (MCID). Univariate analysis (UVA) was performed, with 30-day post-implant dosimetry covariates stratified into quartiles. Median follow-up was 63 mo. Men with NCCN low (n = 42) or favorable-intermediate risk (n = 37) disease were treated with brachytherapy alone, while most with high-risk disease had combined EBRT (n = 17 of 18). Men with UIR disease (n = 52) were selected for monotherapy (n = 42) based on clinical factors and MRI findings. Freedom from biochemical failure-7 yr was 98%. Of 37 men with MRI treated with monotherapy for UIR disease, all 36 men without extraprostatic extension were controlled. Late Grade 2+/3+ toxicity occurred in 55/3% for GU and 8/2% for GI, respectively. Fifty men were sexually active at baseline and had 2 yr sexual data; 37 (74%) remained active at 2 yr. Global scores for urinary incontinence (UC), urinary irritation/obstruction (UIO), bowel function, and sexual function (SF) showed decreases greater than the MCID (p < 0.05) in UC at 2 mo, UIO at 2 and 6 mo, and SF at 2-24 mo, and >5 yr. Analysis did not reveal any significant associations with any examined rectal or urethral dosimetry for late toxicity or QOL. Disease outcomes and patient-reported QOL support LDR brachytherapy, including monotherapy for UIR disease.

Development and pilot-testing of the expanded prostate index composite - Filipino version (EPIC-F).

Quality-of-life (QOL) is paramount in clinical decision-making in the management of prostate cancer patients. The expanded prostate index composite (EPIC) is a widely used and well-validated QOL tool that allows for the evaluation of bowel, urinary, sexual, and hormonal domains. A Filipino translation was previously lacking. We describe the development and pilot testing of the Filipino translation of the EPIC (EPIC-F). The EPIC-32 was translated into Filipino using iterative forward and backward procedures with checks for semantic congruency. The translation was then evaluated by an expert panel consisting of a prostate cancer survivor and pertinent health professionals. A focused group discussion (FGD) was conducted to explore sources of difficulty of use to guide improvement. The linguistically validated translation was evaluated to have cultural relevancy, adequacy, and representativeness by the expert panel, and to have good understandability and answerability by a representative pilot cohort of prostate cancer patients. Seven unsatisfactory items were identified, all pertaining to the sexual domain, and required minimal revision on review during the FGD. The EPIC-F is a linguistically and culturally validated version of the EPIC 32, with good understandability and answerability, permitting clinical use. Its psychometric properties need to be determined to define its utility in clinical research.

A comparative study of patient-reported outcomes after contemporary radiation techniques for prostate cancer

PurposeWe aim to compare health-related quality of life (HRQoL) deterioration at 12 months in low-and intermediate-risk prostate cancer (PCa) patients treated with stereotactic ablative radiotherapy (SABR), high dose-rate brachytherapy (HDR) monotherapy and HDR boost. Material and methodsPatients treated as part of 7 prospective clinical trials were included. All patients had low-or intermediate-risk PCa. Three strategies were considered: SABR, HDR monotherapy and HDR boost. HRQoL was prospectively measured at baseline and 12 months in all trials, using the Expanded Prostate Index Composite (EPIC). A minimally important difference (MID) was defined as a deterioration of HRQoL scores at 12 months compared to baseline ≥0.5 standard deviation of baseline score. Univariate and multivariable logistic regression using generalized estimating equations were used to compare the proportion of patients having MID between groups. A set of sensitivity analyses was conducted. Results648 patients were included: 288, 173 and 187 respectively in the SABR, HDR monotherapy and HDR boost group. On univariate and multivariable analyses, SABR and HDR monotherapy compared to HDR boost, were associated with less deterioration in the urinary (38%, 40% vs. 55%; OR:0.543, 95%CI:0.320–0.922, p = 0.024; OR:0.468, 95%CI:0.432–0.507, p < 0.001) and sexual domains (38%, 42% vs. 47%; OR:0.762, 95%CI:0.645–0.900, p = 0.001; OR: 0.786, 95%CI:0.650–0.949, p = 0.012). These findings wererobust to a variety ofsensitivity analyses. ConclusionRecent monotherapeutic approaches for low- and intermediate-risk PCa are associated with the preservation of patients HRQoL. Ultimately, the questions of efficacy, toxicity, and HRQoL will be best answered by a randomized clinical trial.

Effects of yoga in men with prostate cancer on quality of life and immune response: a pilot randomized controlled trial

BackgroundDiagnosis and treatment of prostate cancer is associated with anxiety, fear, and depression in up to one-third of men. Yoga improves health-related quality of life (QoL) in patients with several types of cancer, but evidence of its efficacy in enhancing QoL is lacking in prostate cancer.MethodsIn this randomized controlled study, 29 men newly diagnosed with localized prostate cancer were randomized to yoga for 6 weeks (n = 14) or standard-of-care (n = 15) before radical prostatectomy. The primary outcome was self-reported QoL, assessed by the Expanded Prostate Index Composite (EPIC), Functional Assessment of Cancer Therapy-Prostate (FACT-P), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT–F), Functional Assessment of Cancer Therapy-General (FACT-G) at baseline, preoperatively, and 6 weeks postoperatively. Secondary outcomes were changes in immune cell status and cytokine levels with yoga.ResultsThe greatest benefit of yoga on QoL was seen in EPIC-sexual (mean difference, 8.5 points), FACIT-F (6.3 points), FACT-Functional wellbeing (8.6 points), FACT-physical wellbeing (5.5 points), and FACT-Social wellbeing (14.6 points). The yoga group showed increased numbers of circulating CD4+ and CD8+ T-cells, more production of interferon-gamma by natural killer cells, and increased Fc receptor III expression in natural killer cells. The yoga group also showed decreased numbers of regulatory T-cells, myeloid-derived suppressor cells, indicating antitumor activity, and reduction in inflammatory cytokine levels (granulocyte colony-stimulating factor [0.55 (0.05–1.05), p = 0.03], monocyte chemoattractant protein [0.22 (0.01–0.43), p = 0.04], and FMS-like tyrosine kinase-3 ligand [0.91 (−0.01, 1.82), p = 0.053].ConclusionsPerioperative yoga exercise improved QoL, promoted an immune response, and attenuated inflammation in men with prostate cancer. Yoga is feasible in this setting and has benefits that require further investigation.Trial registrationclinicaltrials.org (NCT02620033).

10-Year Outcomes Following Proton Therapy for Localized Prostate Cancer

To report 10-year outcomes for patients treated with proton therapy for localized prostate cancer.The 10-year outcomes from a prospective outcome tracking protocol were assessed and reported for 1272 men with localized prostate cancer. Risk groups were classified per NCCN guidelines. Median proton therapy dose was 78 GyRBE (72 to 82 GyRBE) delivered at 1.8 to 2 GyRBE per fraction. Androgen deprivation therapy (ADT) was received by 193 men for a median 6 months (range 1 to 36 months). Biochemical control was defined using the Phoenix definition. Common Terminology Criteria for Adverse Events, version 5.0, was used for toxicity scoring. The International Prostate Symptom Score (IPSS) and Expanded Prostate Index Composite (EPIC) was used for patient-reported outcomes. Freedom from biochemical failure (FFBF) and toxicity rates were calculated using the Kaplan Meier method. EPIC domain score changes considered clinically significant were 5 (bowel), 6 (urinary irritative /obstructive), 7 (urinary incontinence), and 11 (sexual).The median follow-up time was 10.2 years. The 10-year FFBF rates for patients with very low-risk, low-risk, favorable intermediate-risk, unfavorable intermediate-risk, high-risk, and very high-risk prostate cancer were 97%, 96%, 88%, 82%, 68%, 49%, respectively. Median PSA nadir was 0.2 ng/mL. On multivariate analysis, risk category, PSA, and the presence of perineural invasion predicted 10-year biochemical control. The 7- and 10-year grade 3+ gastrointestinal and urologic toxicity rates were 1.0% and 1.3% and 4.1% and 6.2%, respectively. On multivariate analysis (MVA), the use of prescription blood thinners significantly increased the 10-year risk for grade 3+ gastrointestinal toxicity. The use of prescription blood thinners, the presence of diabetes mellitus, a prostate volume 40+ grams, the use of pretreatment alpha blockers, an IPSS score of 15+, and the use of ADT were associated with late grade 3+ genitourinary (GU) toxicity on MVA. The dose-volume histogram parameter V70 (GyRBE) of bladder volume (< 33 cc vs. 33+ cc) also predicted for late grade 3+ GU toxicity on MVA. A clinically significant decline in EPIC sexual summary scores occurred at 10 years (67 to 41). No other clinically significant change was seen in EPIC summary scores.These long-term results show that proton therapy can provide favorable biochemical control outcomes for patients with localized prostate cancer. Additional strategies are needed to improve disease control for patients with very high-risk disease. Late grade 3+ GI toxicity rates are low and, as noted with other radiation modalities, the rate of late grade 3+ GU toxicity increases with time even after 5 years. There was an expected decline in overall sexual function as the patient cohort aged following proton therapy. These long-term results establish benchmarks for future comparative trials.

Dosimetric Predictors of Toxicity and Quality of Life Following Single Fraction High Dose-Rate Prostate Brachytherapy

<h3>Purpose/Objective(s)</h3> Little is known about optimal dose constraints when high dose rate (HDR) brachytherapy is used as monotherapy for prostate cancer. Most dose constraints for HDR monotherapy were extrapolated from predictors of toxicity when HDR brachytherapy was combined with external beam radiotherapy as a boost. We sought to determine clinical and dosimetric predictors of toxicity and health related quality of life (HRQOL) in men treated with HDR brachytherapy as monotherapy. <h3>Materials/Methods</h3> Eligible patients were treated with single fraction HDR brachytherapy as monotherapy on two prospective clinical trials at a single institution. Patients in the first trial (HDR-mono) received a single fraction of 19 Gy without a dominant intraprostatic lesion (DIL) boost, and patients from the second trial (MARS) received 19 Gy in a single fraction with an MRI-guided DIL boost to ≥ 23 Gy. ADT was not used. Univariable and multivariable logistic regression was used to evaluate clinical (age, IPSS score, prostate volume, alpha blocker use at baseline, and receipt of a DIL boost) and dosimetric (prostate V100, V150, V200, D90, Urethral Dmax and D10, and Rectal Dmax and V80) predictors of CTCAE v4 acute/late toxicity and HRQOL changes measured with expanded prostate index composite (EPIC). Three classifications of late minimally clinically important changes (MCICs) were evaluated: small (> 0.5 standard deviation [SD]), moderate (> 1.0 SD) and severe (> 2.0 SD) declines compared to baseline. <h3>Results</h3> 147 patients were included (87 from HDR-mono, 60 from MARS). Median follow-up was 62.8 months. Only increasing prostate size predicted acute GU toxicity ≥ grade 2 (OR 1.05, 95% CI 1.01–1.09, <i>P</i> = 0.021). On multivariable regression, predictors of late GU toxicity ≥ grade 2 were not receiving a DIL boost (OR 3.78, 95% CI 1.88–7.83, <i>P</i> < 0.001) and higher baseline IPSS score (OR 1.89, 95% CI 1.89–3.18, <i>P</i> = 0.015). Rectal and urethral dose constraints were not associated with late GU/GI toxicity ≥ grade 2. Contrary to our hypothesis, small (OR 0.91, 95% CI 0.81–0.98, <i>P</i> = 0.032) and moderate (OR 0.91, 95% CI 0.80–0.98, <i>P</i> = 0.037) urinary MCICs were less frequent in those with higher urethral Dmax. No impact of urethra D10 on urinary MCICs was seen. Rectal Dmax and V80 did not predict bowel MCIC changes at any threshold. <h3>Conclusion</h3> We were unable to identify dose constraints that were predictive of late toxicity or relevant HRQOL changes in single fraction HDR brachytherapy. This suggests dose parameters used in these trials were safe, and that minor variability in plan dosimetry likely has little clinical significance. While increasing urethral Dmax paradoxically predicted for less frequent urinary MCICs, we do not believe this finding is clinically relevant. Further research exploring optimal dose constraints to be used in HDR brachytherapy as monotherapy for prostate cancer is warranted.

Five-Year Outcomes From a Prospective Comparative Effectiveness Study Evaluating External Beam Radiotherapy With Low Dose-Rate Brachytherapy Boost and Prostatectomy for Localized Prostate Cancer

High-quality data comparing radical prostatectomy (RP) and external beam radiotherapy plus low dose-rate brachytherapy boost (EBRT-LDR) are lacking. To better inform treatment selection, we compared patient reported functional outcomes (PROs) through 5 years following RP or EBRT-LDR for localized prostate cancer.Men were enrolled from 2011-2012 on this multicenter prospective study. Enrollment criteria were: 1) age < 80 years, 2) prostate-specific antigen < 50 ng/dL, and 3) a pathologically-confirmed diagnosis of localized prostate adenocarcinoma within 6 months of enrollment. PROs collected at baseline, 0.5, 1, 3, and 5 years included the Expanded Prostate Index Composite (EPIC), Short Form Health Survey (SF-36), and the Clark treatment-related regret scale. Regression models adjusted for patient characteristics and baseline function. Minimum clinically important point differences for EPIC domains were defined: 4-6 bowel function, 5-7 urinary irritation, 6-9 urinary incontinence, and 10-12 sexual function.Among the entire cohort, 112 received EBRT-LDR and 1553 RP. EBRT-LDR patients were older (median [quartiles]: 66 [60-71] vs. 62 [57-66); P < 0.001) and more commonly had high-risk disease (24% vs. 17%; P = 0.039). Compared to treatment with RP, treatment with EBRT-LDR was associated with clinically meaningful worse bowel (adjusted mean difference, [95% confidence interval]: -9.1 [-11.9, -6.4] P < 0.001 at 1 year; -4.0 [-6.9, -1.1], P = 0.006 at 5 years), worse urinary irritative (1 year: -13.4 [-17.6, -9.2], P < 0.001; 5 year: -5.0 [-8.7, -1.3], P = 0.008), and better urinary incontinence function (1 year: 15.1 [11.0, 19.2], P < 0.001; 5 years: 13.3 [7.7, 18.9], P < 0.001) through 5 years. Men reported similar frequency of moderate to big problem with urinary function between treatment groups through 5 years (1 year: 12% RP vs. 15% EBRT-LDR, P = 0.52; 5 years: 13% vs. 15%, P = 0.50). EBRT-LDR was associated with clinically meaningful better sexual function through 1 year (12 [6.5, 17.5]; P < 0.001 at 1 year), however, sexual function was not clinically different at subsequent timepoints (6.7 [-0.1, 13.4], P = 0.05 at 5 years). There were no clinically meaningful differences between treatment groups in physical functioning, emotional well-being, or energy and fatigue. There was no difference in treatment-related regret between groups at 5 years.Compared to RP, EBRT-LDR was associated with clinically meaningful worse urinary irritative and bowel function and better urinary incontinence function through 5 years after treatment. These patient-reported functional outcomes may clarify treatment expectations and help men make informed treatment choices for their localized prostate cancer.

MP27-01 IMPACTS OF NEOADJUVANT HORMONAL THERAPY PRIOR TO ROBOT-ASSISTED RADICAL PROSTATECTOMY ON POSTOPERATIVE HORMONAL- AND SEXUAL-RELATED QUALITY OF LIFE—ASSESSMENT BY PATIENT-REPORTED QUESTIONNAIRE

You have accessJournal of UrologySexual Function/Dysfunction: Evaluation I (MP27)1 Sep 2021MP27-01 IMPACTS OF NEOADJUVANT HORMONAL THERAPY PRIOR TO ROBOT-ASSISTED RADICAL PROSTATECTOMY ON POSTOPERATIVE HORMONAL- AND SEXUAL-RELATED QUALITY OF LIFE—ASSESSMENT BY PATIENT-REPORTED QUESTIONNAIRE Soichiro Ogawa, Kei Yaginuma, Akihisa Hasegawa, Syunta Makabe, Yuki Harigane, Yu Endo, Hitomi Imai, Yuta Matsuoka, Satoru Meguro, Ryo Tanji, Akifumi Onagi, Ruriko Honda-Takinami, Kanako Matsuoka, Seiji Hoshi, Tomoyuki Koguchi, Emina Kayama, Junya Hata, Yuichi Sato, Hidenori Akaihata, Masao Kataoka, and Yoshiyuki Kojima Soichiro OgawaSoichiro Ogawa More articles by this author , Kei YaginumaKei Yaginuma More articles by this author , Akihisa HasegawaAkihisa Hasegawa More articles by this author , Syunta MakabeSyunta Makabe More articles by this author , Yuki HariganeYuki Harigane More articles by this author , Yu EndoYu Endo More articles by this author , Hitomi ImaiHitomi Imai More articles by this author , Yuta MatsuokaYuta Matsuoka More articles by this author , Satoru MeguroSatoru Meguro More articles by this author , Ryo TanjiRyo Tanji More articles by this author , Akifumi OnagiAkifumi Onagi More articles by this author , Ruriko Honda-TakinamiRuriko Honda-Takinami More articles by this author , Kanako MatsuokaKanako Matsuoka More articles by this author , Seiji HoshiSeiji Hoshi More articles by this author , Tomoyuki KoguchiTomoyuki Koguchi More articles by this author , Emina KayamaEmina Kayama More articles by this author , Junya HataJunya Hata More articles by this author , Yuichi SatoYuichi Sato More articles by this author , Hidenori AkaihataHidenori Akaihata More articles by this author , Masao KataokaMasao Kataoka More articles by this author , and Yoshiyuki KojimaYoshiyuki Kojima More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002024.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Neoadjuvant hormonal therapy (NHT) before radical prostatectomy (RP) is not recommended in current guidelines. Despite this recommendation, NHT before RP is sometimes conducted for a small portion of patients in a clinical practice. Not just side effects of hormonal therapy, degenerate postoperative quality life (QOL) remains the major problem even in the era of robot-assisted RP (RARP). In this study, we evaluated the impacts of NHT on hormonal- and sexual- related QOL in patients who underwent RARP. METHODS: A total of 470 patients were enrolled. According to whether NHT was administered at least one time, patients were divided into two groups, the non-NHT group (n=408) and the NHT group (n=62). Hormonal- and sexual-related QOL was measured with the Japanese version of Expanded Prostate Index Composite (EPIC) questionnaire. RESULTS: Hormonal summary scores at 6, 9 months (p=0.002 and 0.017, respectively), function scores before and 3, 6, 9 months after RARP (p=0.005, 0.031, 0.0009 and 0.008, respectively) and bother score at 6 months (p=0.025) in NHT group were statistically lower than those of non-NHT group. Decreased sexual function scores in NHT group was observed before and 6 months after RARP (p=0.027 and 0.021, respectively). Sexual function at 3 months in patients with >5 month-NTH duration significantly worse than that of ≤5 months (p=0.047). On the contrary, significantly worse sexual bother at 3 months was observed in patients with ≤5 month-NHT duration than that of >5 months (p=0.032). All of hormonal and sexual scores were not statistically significant between patients treated with anti-androgen monotherapy and luteinizing hormone-releasing hormone (LH-RH) agonists with/without anti-androgen drugs. CONCLUSIONS: NHT prior to RARP should not be recommended in terms of not only oncological outcome but also the impacts on postoperative hormonal- and sexual-related QOL. Source of Funding: None of the authors has any relevant financial interests, relationships, activities or affiliations pertaining to this study © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e472-e472 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Soichiro Ogawa More articles by this author Kei Yaginuma More articles by this author Akihisa Hasegawa More articles by this author Syunta Makabe More articles by this author Yuki Harigane More articles by this author Yu Endo More articles by this author Hitomi Imai More articles by this author Yuta Matsuoka More articles by this author Satoru Meguro More articles by this author Ryo Tanji More articles by this author Akifumi Onagi More articles by this author Ruriko Honda-Takinami More articles by this author Kanako Matsuoka More articles by this author Seiji Hoshi More articles by this author Tomoyuki Koguchi More articles by this author Emina Kayama More articles by this author Junya Hata More articles by this author Yuichi Sato More articles by this author Hidenori Akaihata More articles by this author Masao Kataoka More articles by this author Yoshiyuki Kojima More articles by this author Expand All Advertisement Loading ...

Prostate high dose-rate brachytherapy as monotherapy for prostate cancer: Late toxicity and patient reported outcomes from a randomized phase II clinical trial

Background and PurposeLong-term toxicity of high dose-rate brachytherapy as monotherapy for prostate cancer is not well defined. We report late toxicity and health related quality of life (HRQOL) changes from a randomized phase II clinical trial of two different fractionation schemes. Materials and MethodsEligible patients had NCCN low or intermediate risk prostate cancer. 170 patients were randomized to receive either a single 19 Gy or two-fractions of 13.5 Gy one week apart. Toxicity was measured using Common Terminology for Adverse Events (CTCAE) v4.0, and HRQOL was measured using the Expanded Prostate Index Composite (EPIC). ResultsMedian follow-up was 63 months. The 5-year cumulative incidence of Grade 2 or higher genitourinary (GU) and gastrointestinal (GI) toxicity was 62% and 12% in the single-fraction arm, and 47% and 9% in the two-fraction arm, respectively. Grade 3 GU toxicity was only seen in the single fraction arm with a cumulative incidence of 2%. The 5-year prevalence of Grade 2 GU toxicity was 29% and 21%, in the single- and two-fraction arms, respectively, with Grade 2 GI toxicity of 1% and 2%. Beyond the first year, no significant differences in mean urinary HRQOL were seen compared to baseline in the two-fraction arm, in contrast to the single-fraction arm where a decline in urinary HRQOL was seen at 4 and 5 years. Sexual HRQOL was significantly reduced in both treatment arms at all timepoints, with no changes in the bowel domain. ConclusionsHDR monotherapy is well tolerated with minimal impact on HRQOL.

Abstract LB-292: A randomized controlled trial of yoga in men with prostate cancer undergoing radical prostatectomy

Abstract Introduction and Objectives: New diagnosis of prostate cancer (PCa) may lead to anxiety, mental distress, fear and depression in up to 30% of men, which can contribute to poor quality of life (QOL). Recent research on Yoga in cancer patients has shown significant improvement in health related QOL, emotional health and fatigue. Given the lack of randomized clinical data regarding the effects of Yoga in PCa, we performed this study to evaluate the potential impact of Yoga on disease-specific QOL in men undergoing radical prostatectomy (RP) for PCa. Material and Method: We randomly assigned newly diagnosed men with localized prostate cancer to Yoga (n = 15) or standard of care (n= 15) prior to their RP. Yoga was given to the intervention group twice a week for 6 weeks for 60 minutes before the surgery and then re-initiated 3 to 6 weeks after the surgery for another six weeks. Self-report measures of QOL [ Expanded Prostate Index Composite (EPIC), Functional Assessment of Cancer Therapy-Prostate (FACT-P), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Functional Assessment of Cancer Therapy-General (FACT-G) and Five Facets of Mindfulness Questionnaire (FFMQ) primary outcomes], blood specimen (cytokine and immune markers; secondary outcome) were collected at baseline, prior to the surgery and 6 weeks after surgery. Results: Improvements in EPIC sexual domain (mean difference: 8.5 points), FACT-P (mean difference: 5.3 points), FACIT-F (mean difference: 5.4 points), and FACT-G (mean difference: 7.2 points) were seen at 6 weeks in the Yoga arm compared with controls. Greatest benefit of Yoga was seen in the subdomains of EPIC sexual function (mean difference: 8.9 points), EPIC sexual bother (mean difference: 7.6 points), FACT emotional wellbeing (mean difference: 5.4 points), FACT functional wellbeing (mean difference 8.3 points) and FACT social wellbeing (mean difference 14.1 points). We identified statistically significant reduction in the inflammatory cytokines- granulocyte colony-stimulating factor (G-CSF; 0.55 [0.05 - 1.05]; p-value = 0.03), Monocyte chemoattractant protein (MCP-1; 0.22 [0.01 - 0.43]; p-value = 0.04), FMS-like tyrosine kinase-3 ligand (FLT-3 L; 0.91 [-0.01 - 1.82]; p-value = 0.053) in the Yoga group during the same time period. Conclusions: A structured Yoga intervention in the preoperative setting improved QOL, especially in the domains of sexual function, social, emotional and functional well-being as well as fatigue. Yoga positively modulates chronic low-grade inflammation which may impact tumor microenvironment. Yoga is feasible and safe and has promising benefits to physical, mental and emotional well-being. Health care providers can utilize the preoperative period as a window of opportunity for an intervention and a teaching moment for the patient to enhance their overall health. Further integrated large-scale research into molecular impact of yoga on markers of inflammation and immune function are essential. Source of Funding: This project was supported by the ThriveWell Cancer Foundation grant to Dharam Kaushik. The content is solely the responsibility of the authors and does not necessarily represent the official views of the ThriveWell Cancer Foundation. Citation Format: Dharam Kaushik, Pankil Shah, Kumar A. Pratap, Ian M. Thompson, Robert S. Svatek, Javier Hernandez, Ian Thompson, Ahmed Mansour, Richapriya Jha, Yang Xiaoyu, Deepak K. Pruthi, Hanzhang Wang, J. Ricardo Rivero, Nydia Darby, Ronald Rodriguez, Michael A. Liss. A randomized controlled trial of yoga in men with prostate cancer undergoing radical prostatectomy [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr LB-292.

Use of EPIC 26 to identify men likely to benefit from surgical interventions for urinary incontinence after radical prostatectomy.

To examine outcomes of surgical procedures for urinary incontinence after radical prostatectomy (post-RP UI) and to identify patients who may benefit from a surgical intervention to treat post-RP UI. A retrospective chart review identified men who underwent radical prostatectomy (RP) from July 2004 through July 2016 at our institution. Cases underwent surgical interventions for UI following RP. Controls had RP during the study period but did not have an intervention for UI following RP. We used the UI scale of the Expanded Prostate Index Composite (EPIC) 26 to: (1) quantify post-RP UI before and after UI intervention overall and for specific surgical procedures; (2) evaluate the significance of improvement in post-RP UI before and after UI intervention and (3) identify controls with levels of post-RP UI that were comparable to the cases. Two thousand nine hundred and sixty-eight RPs were performed; 48 patients underwent further surgical intervention (39 slings, 9 artificial urinary sphincter, AUS). For 20 cases with complete EPIC UI data (15 slings, 5 AUS), the median (IQR) pre-UI intervention score was 27.00 (IQR 22.75-42.75). Improvement was significant overall (p < 0.001) and for slings (p = 0.001). 71/2085 controls had post-prostatectomy UI scores ≤ 27.0, suggesting that they may have benefited from a post-RP surgical intervention for UI. Data support the effectiveness of surgery to treat post-RP UI. A sizeable population of unidentified men may benefit from a surgical intervention to treat urinary incontinence after RP.

Tumor-targeted dose escalation for localized prostate cancer using MR-guided HDR brachytherapy (HDR) or integrated VMAT (IB-VMAT) boost: Dosimetry, toxicity and health related quality of life

PurposeTo report dosimetry, preliminary toxicity and health-related quality of life (HRQoL) outcomes of tumor-targeted dose-escalation delivered by integrated boost volumetric arc therapy (IB-VMAT) or MR-guided HDR brachytherapy (HDR) boost for prostate cancer. Materials and methodsPatients diagnosed with localized prostate cancer, with at least 1 identifiable intraprostatic lesion on multiparametric MRI (mpMRI) were enrolled in a prospective non-randomized phase II study. All patients received VMAT to the prostate alone (76 Gy in 38 fractions) plus a GTV boost: IB-VMAT (95 Gy in 38 fractions) or MR-guided HDR (10 Gy single fraction). GTV was delineated on mpMRI and deformably registered to planning CT scans. Comparative dosimetry using EQD2 assuming α/β 3 Gy was performed. Toxicity and health-related quality of life data (HRQoL) data were collected using CTCAE v.4.0, International Prostate Symptom Score (IPSS) and the Expanded Prostate Index Composite (EPIC). ResultsForty patients received IB-VMAT and 40 HDR boost. Organs at risk and target minimal doses were comparable between the two arms. HDR achieved higher mean and maximal tumor doses (p < 0.05). Median follow-up was 31 months (range 25–48); Acute grade G2 genitourinary (GU) toxicity was 30% and 37.5% in IB-VMAT and HDR boost, while gastrointestinal (GI) toxicity was 7.5% and 10%, respectively. Three patients developed acute G3 events, two GU toxicity (one IB-VMAT and one HDR boost) and one GI (IB-VMAT). Late G2 GU toxicity was 25% and 17.5% in the IB-VMAT and HDR boost arm and G2 GI was 5% and 7.5%, respectively. Two patients, both on the IB-VMAT arm, developed late G3 toxicity: one GI and one GU. No statistically significant difference was found in HRQoL between radiotherapy techniques (p > 0.2). Urinary and bowel HRQoL domains in both groups declined significantly by week 6 of treatment in both arms (p < 0.05) and recovered baseline scores at 6 months. ConclusionIntraprostatic tumor dose escalation using IB-VMAT or MR-guided HDR boost achieved comparable OAR dosimetry, toxicity and HRQOL outcomes, but higher mean and maximal tumor dose were achieved with the HDR technique. Further follow-up will determine long-term outcomes including disease control.

160 Canadian TrueNTH Sexual Health and Rehabilitation eClinic (SHAReClinic) for Prostate Cancer Patients: Results of a Feasibility Study

Sexual dysfunction (SD) after prostate cancer (PC) has a significant negative impact on a patient’s health-related quality of life. The TrueNTH Sexual Health and Rehabilitation eClinic (SHAReClinic) is a Canadian online intervention for patients/couples seeking treatment for sexual dysfunction after treatment for localized PC. The SHAReClinic intervention involves six online clinic visits; one pretreatment and five follow-up visits over a one-year period post PC treatment. Components of SHAReClinic include tailored and structured educational modules, personalized support via an online sexual health counsellor, a virtual library, and tracking and feedback mechanisms for participants. The objectives of this study are: 1) to determine the acceptability, and 2) to inform the effectiveness of an online, biopsychosocial intervention (SHAReClinic) in treating sexual dysfunction and supporting intimacy maintenance following localized PC treatment. This single-arm, prospective feasibility study recruited participants from six healthcare institutions across Canada to enroll in SHAReClinic. Website usage and analytics were analyzed at the end of the study to assess intervention acceptability. Questionnaires were completed at pre-treatment, 6 weeks, 6 months, and 12 months post treatment to inform the intervention effectiveness. Outcome measures for sexual function included the Sexual Health Inventory for Men (SHIM), the Patient-Reported Outcome Measurement Information System (PROMIS)- Interest in Sexual Activity and Sexual Activities, and the sexual health questions of the Expanded Prostate Index Composite (EPIC). Sexual distress and relationship intimacy were measured using the Sexual Distress Scale (SDS) and the Miller Social Intimacy Scale (MSIS) questionnaires respectively. Descriptive statistics were used to summarize the data.

Dose to the bladder neck in MRI-guided high-dose-rate prostate brachytherapy: Impact on acute urinary toxicity and health-related quality of life

PurposeTo assess the impact of the dose to the bladder neck (BN) on acute urinary toxicity (AUT) and health-related quality of life (uHRQoL) in patients with prostate cancer treated with MRI-guided high-dose-rate brachytherapy combined to external beam radiotherapy. Methods and MaterialsSixty-one patients were treated with a single 15-Gy MRI-guided high-dose-rate brachytherapy followed by external beam radiotherapy as part of a prospective Phase II trial. The BN was delineated in retrospect on T2-weighted images. AUT and uHRQoL data were collected prospectively using Common Terminology Criteria for Adverse Events version 4.0 and the expanded prostate index composite. A minimally important difference (MID) was defined as a deterioration of uHRQoL scores at 3 months ≥ 0.5 standard deviation of baseline score. Linear and logistic regression models were used. ResultsThe median BN volume was 0.6 cc. The median BN and urethral maximum dose (BNDmax and UDmax) were 22 Gy and 20 Gy, respectively. BNDmax was significantly associated with UDmax (p = 0.03). AUT Grade 2 + was observed in 32% of patients. Among those, 4 patients had an acute urinary retention (AUR). No Grade 4 + toxicity was reported. At 3 months, 47% of patients reported an MID in urinary uHRQoL. None of the dosimetric parameters including BNDmax was associated with acute Grade 2 + urinary toxicity or MID. However, 3 of 4 patients with AUR had a BNDmax in the highest quartile; >175% of prescription dose. ConclusionsAlthough a high BN dose was observed in patients who had an AUR, the predictive value of this parameter is yet to be determined in a larger cohort.

Visceral adipose ratio as a novel predictor for acute bowel toxicity in patients receiving pelvic radiation: Preliminary dosimetric analysis and clinical validation.

During radiation treatment planning, the small bowel (SB) is often contoured as a 'bowel bag' encompassing the entire peritoneal space that may be occupied by SB. This method incorporates large volumes of visceral adipose, potentially resulting in misleading estimates of radiation dose to the SB. We evaluated the relative volume of adipose within the peritoneal space and applied this as a correction factor to standard bowel bag dosimetric measures, hypothesizing that corrected SB measures would better correlate with acute toxicity. Eighteen consecutive patients receiving pelvic radiation for gynaecologic cancers over a 1-year period at an academic medical centre were included. Bowel function was assessed with the Expanded Prostate Index Composite (EPIC) questionnaire. Bowel bags were contoured on simulation computed tomography (CT) scans. Adipose was auto-contoured using previously published Hounsfield Unit criteria and used to create an adipose correction factor (ACF). The ACF was applied to V45cc and V40% volumes to create adipose corrected measures (AC-V45cc and AC-V40%). Correlations between EPIC scores and dosimetric measures were assessed using Spearman coefficients. V45cc and V40% did not correlate with overall EPIC bowel domain score; however, AC-V40% did show a significant correlation (P=0.02). Correlations of V45cc and V40% with the bowel bother subdomain of EPIC were both significantly improved by applying the ACF (P=0.02 for AC-V45cc; P<0.01 for AC-V40%). Adipose corrected bowel bag dosimetric constraints correlate better with acute bowel toxicity than current standard practice. Longer follow-up is needed to determine if similar findings are seen with late toxicity.

Describing the Spectrum of Patient Reported Outcomes after Radical Prostatectomy: Providing Information to Improve Patient Counseling and Shared Decision Making

PurposePreoperative counseling incorporating the best-case, worst-case, and most-likely outcome scenarios aid patients’ decision making. This information is not readily available for prostate cancer counseling because most patient reported outcomes are presented as averages, which minimize individual patient experiences. Using the Expanded Prostate Index Composite (EPIC), we present data to characterize the best and worst-case after prostatectomy. Materials and MethodsEPIC bowel, urinary irritation and continence, and sexual function scores were measured among 1418 men (stratified by baseline function) undergoing prostatectomy. Patient-level functional trajectories were modeled using a Bayesian hierarchical model. The 5-year best and worst-case outcomes were defined as the upper 95th percentile and lower 5th percentile. ResultsAt 5 years after surgery, among those with good baseline urinary continence, the best-case was a score of 100.0 (95% CrI; 100.0 – 100.0) and worst-case was 54.4 (42.2 – 63.7). Among men with good baseline sexual function undergoing nerve sparing surgery, best-case was 83.9 points (74.1 – 93.1) and worst-case was 17.6 (7.5 – 26.1). The differences between best and worst-case for bowel and urinary irritation were relatively small (11.4 and 13.6 points respectively). ConclusionsProstatectomy exerted minimal negative impact on urinary irritation and bowel function with minimal variability. There was a larger range in patient experience for urinary continence and sexual function with most patients experiencing significant functional decline. Future studies reporting best and worst-case outcomes for multiple treatment modalities may provide valuable information for shared decision making in prostate cancer treatment.

Early toxicity and health-related quality of life results of high-dose-rate brachytherapy as monotherapy for low and intermediate-risk prostate cancer

PurposeTo determine the acute toxicity and effect on health-related quality of life of a two-fraction regimen of high-dose-rate (HDR) prostate brachytherapy. Methods and materialsPatients with low- or intermediate-risk prostate cancer were treated with HDR brachytherapy as monotherapy in two implants of 13.5 Gy spaced 7–14 days apart. Patients completed International Prostate Symptom Score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires at 1, 3, 6, 9, 12, 16, 20, and 24 months after brachytherapy. Proportion of patients in each IPSS category (mild = 0–7, moderate = 8–18, severe = 19+) was evaluated at each of the intervals above. Paired t tests with baseline values were done for IPSS and EPIC scores. ResultsThirty patients were accrued to the study. Median prostate-specific antigen was 8,7 (range 4.1–17.5). T stages were T1c = 65%, T2a = 21%, and T2b = 14%. Twenty-seven percent of patients had a Gleason score of 6 and 73% had a Gleason score of 7. IPSS categories at baseline, 1, 3, 6, 12, and 24 months were mild (81%, 43%, 58%, 62%, 76%, 64%), moderate (19%, 32%, 29%, 30%, 20%, 29%), and severe (0%, 25%, 13%, 7%, 4%, 6%), respectively. There was a significant decrease in EPIC sexual summary scores at 1, 3, 6, and 12 months of 0 points (p < 0.001), 17 points (p = 0.01), 18 points (p = 0.02), and 17 points (p = 0.01), respectively. ConclusionsThis is the first report of this cohort of patients treated with two-fraction HDR monotherapy. This regimen shows rates of toxicity and health-related quality of life that appear acceptable as compared to other treatment modalities. These results are also comparable with other reports with similar treatment regimens.

Initial toxicity, quality-of-life outcomes, and dosimetric impact in a randomized phase 3 trial of hypofractionated versus standard fractionated proton therapy for low-risk prostate cancer

PurposeRandomized evidence for extreme hypofractionation in prostate cancer is lacking. We aimed to identify differences in toxicity and quality-of-life outcomes between standard fractionation and extreme hypofractionated radiation in a phase 3 randomized trial. Methods and materialsWe analyzed the results of the first 75 patients in our phase 3 trial, comparing 38 Gy relative biologic effectiveness (RBE) in 5 fractions (n = 46) versus 79.2 Gy RBE in 44 fractions (n = 29). Patients received proton radiation using fiducials and daily image guidance. We evaluated American Urological Association Symptom Index (AUASI), adverse events (AEs), and Expanded Prostate Index Composite (EPIC) domains. The primary endpoint of this interim analysis was the cumulative incidence of grade 2 (G2) or higher AEs. The randomized patient allocation scheme was a 2:1 ratio favoring the 38 Gy RBE arm. ResultsThe median follow-up was 36 months; 30% of patients reached 48-month follow-up. AUASI scores differed <5 points (4.4 vs 8.6; P = .002) at 1 year, favoring the 79.2 Gy arm. Differences in AUASI were not significant at ≥18 months. EPIC urinary symptoms favored the 79.2 Gy arm at 1 year (92.3 vs 84.5; P = .009) and 18 months (92.3 vs 85.3; P = .03); bother scores were not significant at other time points. Cumulative ≥G2 genitourinary toxicity was similar between the 79.2 Gy and 38 Gy arms (34.5% vs 30.4%; P = .80). We found no differences in the EPIC domains of bowel symptoms, sexual symptoms, or bowel ≥G2 toxicities. Bladder V80 (79.2 Gy arm; P = .04) and V39 (38 Gy arm; P = .05) were predictive for cumulative G2 genitourinary AEs. ConclusionsLow AE rates were seen in both study arms. Early temporary differences in genitourinary scores disappeared over time. Bladder constraints were associated with genitourinary AEs.