Functional Assessment Of Cancer Therapy-Prostate Research Articles

Fatigue, quality of life and metabolic changes in men treated with first-line enzalutamide versus abiraterone plus prednisolone for metastatic castration-resistant prostate cancer (HEAT): a randomised trial protocol

IntroductionEnzalutamide and abiraterone acetate plus prednisolone (AAP) are used in combination with androgen-deprivation therapy to further suppress the androgen stimulation of metastatic castration-resistant prostate cancer (mCRPC). First-line mCRPC treatment with...

Ambulatory Robot-Assisted Laparoscopic Prostatectomy: Is It Ready for Prime Time? A Quality of Life Analysis.

Purpose: To investigate the difference, if any, in the quality of life (QoL) at specified intervals in patients undergoing same day discharge (SDD, ambulatory) vs next day discharge (NDD) after robot-assisted laparoscopic prostatectomy (RALP). Materials and Methods: Two hundred consecutive patients underwent RALP with either SDD or NDD. They completed validated pain and health-related QoL questionnaires at predefined intervals postoperatively and results were compared between the two groups. Results: Pearson's coefficient revealed significant correlations between the time of discharge and physical well-being (r = -0.139; p = 0.005), emotional well-being (EWB) (r = -0.71; p < 0.001), functional assessment of cancer therapy-general (FACT-G) (r = -0.367; p < 0.001), functional assessment of cancer therapy-prostate (FACT-P) (r = -0.273; p < 0.001), pain severity score (PSS) (r = 0.237; p < 0.001), and pain interference score (PIS) (r = 0.214; p < 0.001). Student's t-test revealed significant (p < 0.001) difference in the means of PSS, PIS, EWB, FACT-G, and FACT-P between both groups. Time of discharge was found to be an independent significant predictor (p < 0.01) of PSS and PIS. Pearson's coefficients revealed that PSS had significant correlations with age (r = -0.60; p < 0.001), body mass index (r = 0.87; p < 0.001), and console time (CT) (r = 0.63; p < 0.001). CT also correlated with the estimated blood loss (r = 0.65; p < 0.001). Conclusions: Patients who were discharged the same day as their RALP had lesser pain and interference in general activity scores 2 days after discharge and had better perceived overall health than patients who were discharged on postoperative day 1.

Quality-of-Life Assessment and Reporting in Prostate Cancer: Systematic Review of Phase 3 Trials Testing Anticancer Drugs Published Between 2012 and 2018

Quality of life (QoL) is not included among the end points in many studies, and QoL results are underreported in many phase 3 oncology trials. We performed a systematic review to describe QoL prevalence and heterogeneity in QoL reporting in recently published prostate cancer phase 3 trials. A PubMed search was performed to identify primary publications of randomized phase 3 trials testing anticancer drugs in prostate cancer, issued between 2012 and 2018. We analyzed QoL inclusion among end points, presence of QoL results, and methodology of QoL analysis. Seventy-two publications were identified (15 early-stage, 20 advanced hormone-sensitive, and 37 castration-resistant prostate cancer [CRPC]). QoL was not listed among study end points in 23 studies (31.9%) (40.0% early stage, 40.0% advanced hormone sensitive, and 24.3% CRPC). QoL results were absent in 15 (30.6%) of 49 primary publications of trials that included QoL among end points. Overall, as a result of absent end point or unpublished results, QoL data were lacking in 38 (52.8%) primary publications (53.3% early stage, 55.0% in advanced hormone sensitive, and 51.4% in CRPC). The most commonly used QoL tools were Functional Assessment of Cancer Therapy-Prostate (FACT-P) (21, 53.8%) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (14, 35.9%); most common methods of analysis were mean changes or mean scores (28, 71.8%), time to deterioration (14, 35.9%), and proportion of patients with response (10, 25.6%). In conclusion, QoL data are lacking in a not negligible proportion of recently published phase 3 trials in prostate cancer, although the presence of QoL results is better in positive trials, especially in CRPC. The methodology of QoL analysis is heterogeneous for type of instruments, analysis, and presentation of results.

Health-related quality of life (HRQoL) and pain progression with enzalutamide (ENZ) in metastatic hormone-sensitive prostate cancer (mHSPC) from the ARCHES study.

5044 Background: The Phase 3 ARCHES trial (NCT02677896) evaluated the efficacy and safety of ENZ + androgen deprivation therapy (ADT) vs placebo (PBO) + ADT in 1150 men with mHSPC. Here we report patient-reported outcome (PRO) data using Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory Short Form (BPI-SF). Methods: FACT-P and BPI-SF were assessed at baseline (BL), week (wk) 13, and then every 12 wks until disease progression. Longitudinal changes were assessed using mean scores and mixed-model repeated measures; lower BPI-SF scores represent less pain/interference; higher FACT-P scores represent better HRQoL. Time from BL to first deterioration in PRO score was assessed by Kaplan-Meier estimates and Cox proportional hazards models. Clinically meaningful difference was defined by change from baseline ≥10 for FACT-P total and ≥2 for worst pain/severity. Results: PRO instrument completion rates were high (88−96%) up to wk 73. At BL, men in both arms were generally asymptomatic and reported good HRQoL (FACT-P total: ENZ + ADT, 113.9; PBO + ADT, 112.7) and low pain (worst pain [item 3]: ENZ + ADT, 1.80; PBO + ADT, 1.77). HRQoL and pain scores remained stable over time and there were no clinically meaningful differences between groups in change from BL to wk 73. The proportion of men with no change or improvement in PRO scores (67–88%) was similar in both groups at all time points up to wk 73. There was no significant difference between arms for time to deterioration in FACT-P total (HR 0.90 [95% CI] (0.74, 1.09); p = 0.2998). ENZ + ADT significantly delayed time to pain progression for worst pain (HR 0.82 [0.69, 0.98]; p = 0.0322) and pain severity (HR 0.79 [0.65, 0.97]; p = 0.0209) vs PBO + ADT. Conclusions: Men with mHSPC were generally asymptomatic and had high levels of HRQoL and low levels of pain at BL, likely due to most men initiating ADT several months prior to study entry. No clinically meaningful differences in HRQoL were observed between ENZ and PBO. The prolongation in radiographic progression-free survival observed with ENZ + ADT was accompanied by a significantly prolonged time to progression of worst pain and pain severity vs PBO + ADT. Clinical trial information: NCT02677896.

25 - The functional assessment of cancer therapy-prostate (FACT-P) scales in men 45-55 years of age with prostate cancer

25 - The functional assessment of cancer therapy-prostate (FACT-P) scales in men 45-55 years of age with prostate cancer

Health utility and health-related quality of life of Japanese prostate cancer patients according to progression status measured using EQ-5D-5L and FACT-P.

To obtain health utility data to allow for cost-effectiveness analysis in groups stratified by disease progression along with health-related quality of life (HRQoL) information in Japanese prostate cancer (PC) patients. In this cross-sectional observational study, EuroQol-5 Dimension- 5 Level (EQ-5D-5L), EuroQol Visual Analog Scale (EQ-VAS), and Functional Assessment of Cancer Therapy-Prostate (FACT-P) measures were used to examine utility, VAS scores, and disease-specific HRQoL, respectively. Scores obtained were statistically examined for the correlation among measures and domains. Parameter estimates of statistically significant factors were assessed using generalized linear models (GLM). A total of 380 patients stratified by their disease progression status were analyzed. The numbers (%) of patients in groups stratified as having localized (L), localized progression (LP), distant metastatic (DM), and DM-castration-resistant PC (CRPC) were 275 (72.4), 40 (10.5), 27 (7.1), and 38 (10.0), respectively. EQ-5D-5L mean (standard deviation, SD) scores of L, LP, DM, and DM-CRPC in study participants were 0.87 (0.15), 0.86 (0.15), 0.85 (0.18), and 0.84 (0.17), respectively. The mean (SD) scores assessed by EQ-5D-5L, EQ-VAS, and FACT-P instruments were 0.86 (0.16), 74.6 (16.8), and 110.8 (19.6), respectively. Utility scores correlated well with FACT-P scores. Eastern Cooperative Oncology Group performance status had significant influences on all instruments' scores. We obtained health utility and HRQoL scores of Japanese PC patients stratified by disease progression in detail. Our results will be useful for establishing cost-effectiveness analyses in Japanese PC settings.

Quality of life among patients after cystoprostatectomy as the treatment for locally advanced prostate cancer with bladder invasion

Purpose This study aimed to evaluate the changes of patients’ quality of life (QoL) after cystoprostatectomy as a treatment for locally advanced prostate cancer (LAPC) with the bladder invasion and to determine risk factors for postoperative poor QoL. Materials and methods Between Jan 2012 and December 2015, 27 patients who received cystoprostatectomy for LAPC with the bladder invasion were retrospectively included. QoL was assessed with the functional assessment of cancer therapy-prostate (FACT-P) questionnaire scores. Determinants for postoperative poor QoL were investigated using univariate and multivariate regression analysis. Results Three-year overall survival, biochemical progression-free survival, and clinical progress-free survival were 88.89%, 62.96% and 77.78%, respectively. Preoperative symptoms of hematuria, urinary frequency, and dysuria were well alleviated after cystoprostatectomy. Moreover, FACT-P questionnaire scores at 6 months and 1 year after cystoprostatectomy were significantly higher than preoperative scores. Univariate and multivariable analysis (p < .05) showed that postoperative complication was the independent risk factor for the loss of postoperative QoL. Conclusions Patients’ QoL can be improved after cystoprostatectomy as the treatment for LAPC with the bladder invasion, which is associated with ameliorative urinary symptoms after the surgery. Besides, surgical complication is identified to be a risk factor for postoperative poor QoL.

Health-related quality of life (HRQoL) in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with olaparib in combination with abiraterone.

234 Background: A Phase II trial showed that addition of olaparib (O) to abiraterone (A) led to significant radiographic progression-free survival benefit for patients (pts) with mCRPC vs placebo (P) + A (hazard ratio [HR] 0.65, 95% confidence interval [CI] 0.44–0.97). We report predefined exploratory HRQoL analyses. Methods: This randomized, double-blind trial enrolled pts with mCRPC, post-docetaxel. Pts were randomized (71 per arm) to receive either O (300 mg bd, tablets) + A (1000 mg od) or P + A; all received prednisone (5 mg bd). Pts completed Functional Assessment of Cancer Therapy-Prostate (FACT-P total score [TS]; range 0–156, higher score = better HRQoL), Brief Pain Inventory–Short Form (BPI-SF) and worst bone pain (wbp) questionnaires (both range 0–10, higher score = more severe pain). Adjusted mean change from baseline was analysed using a mixed model for repeated measures, improvement by logistic regression and deterioration by log-rank test. Results: Overall compliance rates (O + A vs P + A) were 97% vs 96%, 92% vs 85%, and 96% vs 92% for FACT-P, BPI-SF and wbp, respectively. Best FACT-P TS response of ‘improved’ (increase ≥6 points from baseline at two consecutive visits) was reported by 22/67 (33%) evaluable pts in the O + A vs 18/64 (28%) pts in the P + A arm; the odds ratio (1.32; 95% CI 0.64–2.78) favored the O + A arm. Best FACT-P TS response of ‘worsened’ (decrease ≥6 points from baseline) was reported by 15 (22%) vs 22 (34%) pts. Adjusted mean change from baseline in FACT-P TS across all visits was -0.60 vs -2.09 in the O + A and P + A arms, respectively (difference 1.48; 95% CI -3.96–6.92). Time to deterioration (TTD) results are shown in the table. Clinical trial information: NCT01972217. Conclusions: Whilst not statistically significant, in this study a higher percentage of pts treated with O + A vs P + A had improved HRQoL, with fewer pts negatively affected. Ongoing phase III studies will help elucidate the impact of O on HRQoL in pts with mCRPC. (NCT01972217)[Table: see text]

Meaningful differences and validity for the NCCN/FACT-P Symptom Index: An analysis of the ALSYMPCA data.

The Functional Assessment of Cancer Therapy-Prostate (FACT-P) and the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy-Prostate Symptom Index-17 (NFPSI-17) are 2 commonly used measures for patient-reported outcomes in prostate cancer trials. Their use may be enhanced by a better understanding of how change scores on the measures should be interpreted. Using data from the phase 3 Alpharadin in Symptomatic Prostate Cancer Patients trial, this study estimated important change scores on the FACT-P and the NFPSI-17 via a combination of distribution- and anchor-based methods. These data were also used to establish evidence for the validity of the NFPSI-17. The available data suggested the following important difference ranges: 2 to 4 points for the Prostate Cancer Subscale, 5.5 to 8.5 points for the Trial Outcome Index, 1 to 1.5 points for the 3-item Pain Scale, 1 to 2 points for the 4-item Pain Scale, 4 to 6 points for the NFPSI-17, 2 to 3.5 points for NFPSI-Disease-Related Symptoms-Physical, 0.5 points for NFPSI-Disease-Related Symptoms-Emotional, 1 to 1.5 points for NFPSI-Treatment Side Effects, and 0.5 to 1 point for NFPSI-Function/Well-Being. The internal consistency reliability of the NFPSI-17 and most of its subscales was good to excellent (>.70). Significant support was also found for the known groups validity of the NFPSI-17 (and most of its subscales) on the basis of the Eastern Cooperative Oncology Group performance status, the total alkaline phosphatase, the presence of a skeletal-related event during treatment, and the prostate-specific antigen response before the end of treatment. The secondary analysis supports the continued use of the FACT-P, the NFPSI-17, and its related subscales in future research on the quality of life of patients with symptomatic castration-resistant prostate cancer with bone metastases.

Adjuvant hormone therapy after radical prostatectomy in high-risk localized and locally advanced prostate cancer: First multicenter, observational study in China.

ObjectivePotential of combined androgen blockade (CAB) has not been explored extensively in Chinese males with prostate cancer (PCa). Therefore, this study evaluated the 2-year prostate-specific antigen (PSA) recurrence rate and quality of life (QoL) in patients with high-risk localized and locally advanced PCa receiving adjuvant hormone therapy (HT) after radical prostatectomy (RP).MethodsThis prospective, multicenter, observational study conducted in 18 centers across China enrolled patients with high-risk factor (preoperative PSA>20 ng/mL or Gleason score >7) or locally advanced PCa. Different adjuvant HT were administered after RP according to investigator’s decision in routine clinical practice. Relationship of baseline and postoperative characteristics was assessed with recurrence rate. PSA recurrence rate and Functional Assessment of Cancer Therapy-Prostate (FACT-P) QoL scores were recorded at 12 months and 24 months. Kaplan-Meier analysis was used to construct the PSA recurrence rate during follow-up.ResultsA total of 189 patients (mean age: 66.9±6.5 years) were recruited, among which 112 (59.3%) patients showed serum PSA>20 ng/mL preoperatively. The highest postoperative pathological advancement noticed was from clinical T2 (cT2) to pathological T3 (pT3) (43.9%) stage. The majority of the patients (66.1%) received CAB as adjuvant HT, for a median duration of 20.0 months. The least recurrence (15.2%) was noticed in patients treated with CAB, followed by those treated with luteinizing hormone-releasing hormone agonist (LHRHa) (16.1%), and antiandrogen (19.0%), with non-significant difference noted among the groups. None of the baseline or postoperative characteristics was related with PSA recurrence in our study. The 24-month FACT-P QoL score of 119 patients treated for >12 months showed significant improvement above baseline compared with those treated for ≤12 months.ConclusionsAdjuvant CAB therapy after RP showed reduction trend in 2-year PSA recurrence rate in high-risk Chinese patients with localized and locally advanced PCa, compared with adjuvant anti-androgens (AA) or LHRHa therapy. Further long-term therapy (>12 months) significantly improved QoL compared to short-term HT therapy, suggesting the beneficial effect of long-term CAB therapy in improving QoL.

Health-related Quality of Life for Abiraterone Plus Prednisone Versus Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer: Results from a Phase II Randomized Trial

BackgroundAbiraterone and enzalutamide are associated with side effects that may impair health-related quality of life (HRQoL). ObjectiveTo assess patient-reported HRQoL, depression symptoms, and cognitive function for abiraterone versus enzalutamide. Design, setting, and participantsWe randomized 202 patients in a phase II study of abiraterone versus enzalutamide for first-line treatment of metastatic castration-resistant prostate cancer (ClinicalTrials.gov: NCT02125357). InterventionPatients completed Functional Assessment of Cancer Therapy—Prostate (FACT-P) and Patient Health Questionnaire-9 (PHQ-9) questionnaires, and Montreal Cognitive Assessment (MoCA) cognitive assessments at baseline and on treatment. Outcome measurements and statistical analysisTo compare the change in FACT-P scores over time between treatment arms, we used a mixed model for repeated measures (MMRM). For FACT-P domains where there was an interaction between the treatment arm and age, we constructed separate models for patients aged <75 and ≥75yr. We compared the proportion of patients with clinically meaningful change from baseline for FACT-P, and the proportion of patients with an abnormal score and median change from baseline for PHQ-9 and MoCA using Fisher's exact test and Mann-Whitney U test. Results and limitationsIn the MMRM analysis, there was a positive test for interaction in the treatment arm by age for total FACT-P (p=0.048). FACT-P change from baseline over time was better for abiraterone than for enzalutamide in the ≥75-yr model (p=0.003), with no difference in the <75-yr model (p>0.9). A higher proportion of patients experienced clinically meaningful worsening with enzalutamide for the physical and functional well-being domains (37% vs 21%, p=0.013; 39% vs 23%, p=0.015). The distribution of change in PHQ-9 scores from baseline favored abiraterone at weeks 4, 8, and 12. These analyses were not prespecified, and results should be considered to be hypothesis generating. ConclusionsPatient-reported outcomes favored abiraterone compared with enzalutamide with differences in FACT-P HRQoL and PHQ-9 depression scores. Differences in the total FACT-P scores were seen only in the elderly patient subgroup. Patient summaryIn this report, we examined the change in patient-reported quality-of-life scores from the start of treatment over time for patients treated with abiraterone versus enzalutamide for metastatic castration-resistant prostate cancer. We found that elderly patients treated with abiraterone had better quality of life over time, with no difference between treatments for the younger subgroup of patients.

Treatment Experiences, Information Needs, Pain and Quality of Life in Men with Metastatic Castrate-resistant Prostate Cancer: Results from the EXTREQOL Study

AimsDelaying progression, ameliorating symptoms and maintaining quality of life (QoL) are primary aims of treatment for metastatic castrate-resistant prostate cancer (mCRPC). Real-world rather than clinical trial data about symptoms and side-effects are sparse. In EXTREQOL, patients' QoL, pain and information needs were recorded during treatment. Material and methodsMen with mCRPC from 20 UK cancer centres starting various systemic mCRPC treatments completed QoL, pain and information needs questionnaires at baseline, 3 and 6 months. ResultsIn total, 132 patients were recruited. Overall QoL declined significantly by 6 months (Functional Assessment of Cancer Therapy-Prostate [FACT-P] mean = –3.89, 95% confidence interval –6.7 to –1.05, P = 0.007; Trial Outcome Index [TOI] analysis mean = –3.10, 95% confidence interval –5.34 to –0.83, P = 0.007). Those who came off novel therapy and remained on luteinising hormone-releasing hormone agonist therapy alone had worse scores than patients receiving concomitant chemotherapy (Prostate Concerns Subscale mean difference = –4.45, 95% confidence interval –7.06 to –1.83, P = 0.001; TOI mean difference = –5.62, 95% confidence interval –10.97 to –0.26, P = 0.040). At 3 and 6 months, men who reported pain at baseline improved (43%, 40%), but for others pain levels remained the same (45%, 42%) or worsened (13%, 18%). Information regarding supportive care was lacking throughout the period of time on the study. ConclusionMost mCRPC treated patients experience reduced QoL and inadequate pain control. More help with pain management and better information provision regarding supportive care is warranted.

Qualitative and Quantitative Assessment of Patient and Carer Experience of Chemotherapy (Docetaxel) in Combination with Androgen Deprivation Therapy (ADT) for the Treatment of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

IntroductionRecent studies suggest that docetaxel plus androgen deprivation therapy can prolong survival among men with metastatic hormone-sensitive prostate cancer (mHSPC). However, as a cytotoxic therapy, there is a need to understand the experiences of men with mHSPC receiving docetaxel and their carers in a real-world setting.MethodsDuring phase 1, semi-structured qualitative interviews were conducted with men with mHSPC (n = 31) and their carers (n = 14) in Europe to elicit in-depth data concerning their experiences with docetaxel. Eighteen men were also asked to record their experiences in a diary for 7 days. During phase 2, men with mHSPC (n = 161) and carers of men with mHSPC (n = 135) completed an online survey comprising self-report questionnaires including the Cancer Therapy Satisfaction Questionnaire, Brief Fatigue Inventory, Functional Assessment of Cancer Therapy-Prostate, EuroQol-5-Dimensions and the Burden Scale for Family Caregivers (carers only).ResultsAt the outset of therapy, men reported a willingness to take docetaxel to prolong their life, despite being fearful of the potential side effects and impacts on their daily lives. Patient and carer experiences were generally consistent with pre-treatment expectations. However, variations in individual experiences and their ability to tolerate side effects were evident. Fatigue emerged as a prominent symptom with the majority (n = 98, 60.9%) of men reporting experiencing moderate-severe fatigue in the past 24 h. Participant ratings of fatigue were strongly correlated with health-related quality of life (r = − 0.82). Nausea, diarrhoea and sore mouth were also among the most bothersome symptoms for participants.ConclusionsFindings from this study highlight that real-world experience of docetaxel may differ from that observed in clinical trials and that care must be taken to ensure that treatment options are tailored to the needs of individual patients to promote not only how long patients survive but also the quality of that survival.FundingJanssen

812P - Post hoc responder analysis of health‐related quality of life (HRQL) in patients with metastatic castration‐resistant prostate cancer (mCRPC) receiving cabazitaxel in the phase III PROSELICA and FIRSTANA trials

Background: PROSELICA (NCT01308580) assessed the non-inferiority of cabazitaxel 20 mg/m2 (C20) vs 25 mg/m2 (C25) in patients (pts) with mCRPC post docetaxel, while FIRSTANA (NCT01308567) investigated whether C20 and C25 were superior to docetaxel 75 mg/m2 (D75) in chemotherapy-naive mCRPC. This analysis evaluated the impact of cabazitaxel on HRQL in both trials. Methods: Alongside pain and analgesic score, HRQL was assessed using the Functional Assessment of Cancer Therapy Prostate (FACT-P) questionnaire. The analysis focused on FACT-P (clinically meaningful improvement or deterioration of total score [TS]) among responders. Results: Pt baseline characteristics are shown in the table. In PROSELICA, 57.2% and 59.4% of pts receiving C20 and C25 had FACT-P TS improvements; in FIRSTANA, 63.5%, 62.3% and 57.7% of pts receiving C20, C25 and D75 had FACT-P TS improvements. In FACT-P responders, FACT-P TS improvements occurred as early as Cycle (C) 1 (mean change from baseline: PROSELICA C20 10.4, n = 264; C25 10.6, n = 266; FIRSTANA C20 11.7, n = 206; C25 11.7, n = 202; D75 9.0, n = 195); these were largely maintained. For pts with a pain response in PROSELICA, FACT-P TS improvements occurred as early as C1 (C20 6.8, n = 71; C25 11.1, n = 81) and were maintained until C8 (C20 10.6, n = 43; C25 9.6, n = 44). In FIRSTANA, FACT-P TS improvements in pts with a pain response were seen as early as C1 or C2 (C1: C20 15.5, n = 41; C25 12.5, n = 41; D75, 7.9, n = 32) and maintained until C9 (C20 9.0, n = 27; C25 10.5, n = 26; D75 16.4, n = 20). In pts with a tumor or PSA response, HRQL was maintained for all treatment arms in both studies. Additional results for clinical responder subgroups and FACT-P subscales will be presented.Table: 812PBaseline characteristicsFIRSTANAPROSELICAD75 (n = 391)C20 (n = 389)C25 (n = 388)C20 (n = 598)C25 (n = 602)Median age, years (range)69.0 (41–87)68.0 (44–90)68.5 (42–85)68.0 (45–89)69.0 (45–88)ECOG PS, n (%)0–1374 (95.7)370 (95.1)376 (96.9)539 (90.1)540 (89.7)217 (4.3)19 (4.9)12 (3.1)59 (9.9)62 (10.3)Mean PSA, ng/mL (SD)252.8 (625.2)213.2 (434.2)257.9 (578.8)451.5 (881.0)444.0 (834.0)Median present pain intensity, score (range)1.0 (0.0–4.0)1.0 (0.0–4.0)1.0 (0.0–4.0)1.0 (0.0–5.0)2.0 (0.0–5.0)Median FACT-P TS (range)107.4 (41.1–152.0)107.1 (47.2–151.0)105.7 (40.1–148.8)102.8 (37.0–152.8)101.6 (33.9–150.9)C20, cabazitaxel 20 mg/m2; C25, cabazitaxel 25 mg/m2; D75, docetaxel 75 mg/m2; ECOG PS, Eastern Cooperative Oncology Group Performance Status; FACT-P TS, Functional Assessment of Cancer Therapy Prostate Total Score; PSA, prostate-specific antigen; SD, standard deviation. Open table in a new tab C20, cabazitaxel 20 mg/m2; C25, cabazitaxel 25 mg/m2; D75, docetaxel 75 mg/m2; ECOG PS, Eastern Cooperative Oncology Group Performance Status; FACT-P TS, Functional Assessment of Cancer Therapy Prostate Total Score; PSA, prostate-specific antigen; SD, standard deviation. Conclusions: More than half of the pts experienced HRQL improvements, which were maintained. Pts with a pain response experienced HRQL improvements. Funding: Sanofi. Clinical trial identification: PROSELICA: NCT01308580. FIRSTANA: NCT01308567. Editorial acknowledgement: Editorial assistance was provided by Mark Cockerill of MediTech Media Ltd, funded by Sanofi. Legal entity responsible for the study: Sanofi. Funding: Sanofi. Disclosure: A. Thiery Vuillemin: Employee: AstraZeneca; Consultancy, advisory role: Novartis, Sanofi, Astellas, Pfizer, Janssen, Ipsen, Pfizer; Research funding: Pfizer; Travel, accommodation and expenses: Novartis, Sanofi, Pfizer. K. Fizazi: Honoraria: Janssen, Sanofi, Astellas, Takeda; Consultancy, Advisory role: Janssen Oncology, Bayer, Astellas, Sanofi, Orion Pharma GmbH, Curevac, AstraZeneca, ESSA, Genentech; Travel, accommodation and expenses: Amgen. O. Sartor: Advisor: Bellicum Pharmaceuticals, Dendreon; Advisor and expenses: Bayer, Johnson & Johnson, Medivation, Oncogenex, Sanofi, Tokai Pharmaceuticals, AstraZeneca, Progenics; Institute: funding: Bayer, Johnson & Johnson, Sanofi, Dendreon, Endocyte, Innocrin Pharma, Progenics. S. Oudard: Consultancy, advisory role, honoraria, expenses: Sanofi, Astellas, Janssen, Ipson; Research funding: Sanofi; Speakers bureau: Sanofi, Janssen. D. Bury: Contractor: Sanofi; Employee: Artech. S. Guillonneau, A. Ozatilgan: Employee: Sanofi. M. Eisenberger: Honoraria, Consultancy, Advisory role: Sanofi, Pfizer, Astellas; Research: Sanofi; Expenses: Sanofi, Pfizer. J.S. de Bono: Honoraria: Sanofi; Advisor: Sanofi, AstraZeneca, GSK, Genentech, Roche, Merck; Speakers’ bureau: AstraZeneca/MedImmune; Research funding (institute): AstraZeneca/MedImmune, GSK, Sanofi, Merck Sharp & Dohme, Genmab, Genentech; Patent on abiraterone acetate with prednisone.

Detailed analysis of patient-reported lower urinary tract symptoms and effect on quality of life after robotic radical prostatectomy

ObjectiveTo prospectively evaluate short- to medium-term patient-reported lower urinary tract symptoms (LUTS) and their effect on health-related quality of life (HRQoL) using validated questionnaires in a large cohort of patients following robotic-assisted radical prostatectomy (RARP) for prostate cancer. Materials and methodsHRQoL and LUTS outcomes were prospectively assessed in 357 consecutive men undergoing RARP at a single center from 2012 to 2015 using the functional assessment of cancer therapy—prostate (FACT-P) and the international consultation on incontinence modular questionnaire—male LUTS (ICIQ-MLUTS). Questionnaires were administered at baseline, 6, 12, and 18 months. Data were analyzed using paired t-tests and ANOVA. ResultsQuestionnaire completion rates were high (over 60% of eligible men completed 18-month follow-up). Mean Total FACT-P did not significantly change after RARP: 125.95 (standard deviation [SD] = 19.82) at baseline and 125.86 (SD = 21.14) at 18-months (P = 0.55). Mean total ICIQ-MLUTS also remained unchanged: 18.69 (SD = 10.70) at baseline and 18.76 (SD = 11.33) at 18-months (P = 0.11). Mean voiding score significantly reduced from 10.34 (SD = 5.78) at baseline to 6.33 (SD = 3.99) at 6 months after RARP (P<0.001). A reciprocal significant increase in storage score was observed: 5.34 (SD = 4.26) at baseline, 9.65 (SD = 5.71) at 6 months (P<0.001). Subanalyses of ICIQ-MLUTS scores revealed increases in storage symptoms were exclusively within urinary incontinence domains and included significant increases in both urge and stress urinary incontinence scores. ConclusionOverall, patient-reported outcome measures evaluating HRQoL and LUTS do not significantly change after RARP. Detailed analysis reveals significant changes within LUTS domains do occur after surgery which could be overlooked if only total LUTS scores are reported.

Perceptions of masculinity and body image in men with prostate cancer: the role of exercise.

The goal of this study was to explore the association between levels of exercise and patterns of masculinity, body image, and quality of life in men undergoing diverse treatment protocols for prostate cancer. Fifty men with prostate cancer (aged 42-86) completed self-report measures. Self-reported measures included the following: the Godin Leisure Time Exercise Questionnaire (GLTEQ), Masculine Self-esteem Scale (MSES), Personal Attributes Questionnaire (PAQ), Body Image Scale (BIS), and the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Masculinity, body image, and quality of life scores were compared between men obtaining recommended levels of exercise (aerobic or resistance) and those not obtaining recommended level of exercise. Secondary outcomes included the association between masculinity, body image, and quality of life scores as they relate to exercise levels. There were significantly higher scores of masculinity (p < 0.01), physical well-being (p < 0.05), prostate cancer specific well-being (p < 0.05), and overall quality of life (p < 0.05) in those obtaining at least 150min of moderate to vigorous aerobic exercise. In the 48% of men who had never received androgen deprivation therapy, significantly higher levels of masculinity, body image, and quality of life were observed in those meeting aerobic guidelines. Whether treatment includes androgen deprivation or not, men who participate in higher levels of aerobic exercises report higher levels of masculinity, improved body image, and quality of life than those who are inactive. Future longitudinal research is required evaluating exercise level and its effect on masculinity and body image.

MP87-11 INTERIM ANALYSIS OF AN OPEN LABEL PHASE II STUDY OF ENZALUTAMIDE AND RADIUM RA 233 DICHLORIDE IN SYMPTOMATIC, METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS.

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) IV1 Apr 2018MP87-11 INTERIM ANALYSIS OF AN OPEN LABEL PHASE II STUDY OF ENZALUTAMIDE AND RADIUM RA 233 DICHLORIDE IN SYMPTOMATIC, METASTATIC CASTRATION-RESISTANT PROSTATE CANCER PATIENTS. Neal Shore, Paul Schellhammer, Ronald Tutrone, Neil Mariados, and Stacey Harrelson Neal ShoreNeal Shore More articles by this author , Paul SchellhammerPaul Schellhammer More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Neil MariadosNeil Mariados More articles by this author , and Stacey HarrelsonStacey Harrelson More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.2911AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We performed a prospective, multicenter, open label trial investigating the safety and tolerability and clinical efficacy of combining Enzalutamide, an androgen receptor inhibitor, with Radium Ra 223 dichloride, a targeted alpha radiotherapy and the combination subsequent effect upon patients with symptomatic, bone metastatic castration-resistant prostate cancer (mCRPC) patients. METHODS This open-label, phase II study (NCT02507570) enrolled patients with symptomatic bone metastases. Patients were assessed at baseline, day 1 of each of 6 Ra-223 cycles, and 30 days post final RA-223 treatment. The primary objective was safety and tolerability. Secondary objectives included bone pain response via the Bone Pain Index Short Form (BPI-SF), quality of life via the Functional Assessment of Cancer Therapy-Prostate (FACT-P), disease progression, palliative radiotherapy requirement, analgesic advancements, PSA and ALP progression, additional antineoplastic therapy, Eastern Co-operative Oncology Group performance status (ECOG), and overall survival. Data summaries from initiation of RA-223 through 30 day post RA-223 treatment are presented. RESULTS Of the 39 men ages 70±8.2 years that received at least two cycles of RA-223, 34 have completed 6 cycles of RA treatment and are continuing follow-up in this ongoing trial. A total of 10.3% (4/39) of patients reported serious adverse events (AEs) on or after RA-223 initiation, none were related to the treatment, and 53.8% (21/39) of patients had related non-serious AEs, most commonly fatigue, nausea, anemia/worsening of anemia, and decreased appetite. There were no deaths and no progression requiring additional antineoplastic therapy during this treatment phase. Average BPI-SF pain severity composite improved 0.7 to 1.2 at scheduled visits with RA-223 administered. Both BPI-SF interference composite and FACT-P quality of life have positive trends but were not statistically significant. ECOG performance status remained consistent. PSA improved 25% and 50% in 62.9% and 40% of patients, respectively, and ALP improved 25% and 50% in 62.9% and 40% of patients, by end of treatment. CONCLUSIONS This prospective combination trial of Radium 223 and Enzalutamide demonstrates tolerability of use of these approved mCRPC agents with an acceptable safety profile and suggestion of improvement in pain scores, quality of life measures, and maintenance of performance status. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e1191-e1192 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Neal Shore More articles by this author Paul Schellhammer More articles by this author Ronald Tutrone More articles by this author Neil Mariados More articles by this author Stacey Harrelson More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

A Phase II, Randomized, Multicenter Study Comparing 10 Months versus 4 Months of Degarelix Therapy in Prolonging the Off Treatment Interval in Men with Localized Prostate Cancer Receiving Intermittent Androgen Deprivation Therapy for Biochemical Recurrence following Radical Local Therapy

Clinical trials in men initiating intermittent androgen deprivation therapy have used a range of induction durations between 3 and 12 months. We sought to determine whether the duration of induction androgen deprivation therapy would influence the duration of the off treatment interval and the recovery of serum testosterone. This was a prospective, randomized, open label study. Men with biochemical recurrence after local therapy for prostate cancer and a negative bone scan were randomized to 4 and 10 months of monthly degarelix. The first dose was 240 mg and subsequent doses were 80 mg per month. Quality of life was evaluated by the I-PSS (International Prostate Symptom Score), the PAS-SFI (Problem Assessment Scale of the Sexual Function Index) and the FACT-P (Functional Assessment of Cancer Therapy-Prostate). A total of 90 patients were randomized, including 43 to 4 months and 47 to 10 months of treatment. There was no difference in any relevant baseline laboratory parameter, including prostate specific antigen and testosterone. There was no difference between the 2 treatment groups in time off treatment (HR 1.51, 95% CI 0.60-3.84, p = 0.38). Actuarial median time to testosterone recovery to 8.0 nmol/l or greater was 8.05 months (95% CI4.34-39.89) in the 10-month treatment arm and 6.24 months (95% CI5.45-15.90) in the 4-month treatment arm. The log rank test showed no statistical significance between the 2 treatment groups in time to testosterone recovery (p = 0.8392). There was no difference in the testosterone recovery rate between the 2 arms. Men younger than 65 years had a considerably shorter interval off treatment and time to testosterone recovery. There was a lesser adverse effect on quality of life at the end of treatment in the 4-month than in the 10-month arm. In men with biochemical recurrence who initiated intermittent androgen deprivation therapy with degarelix no difference was observed in the duration of the off treatment interval or the rate of testosterone recovery whether they received 4 or 10 months of induction androgen deprivation therapy.

Indirect treatment comparison (ITC) of abiraterone acetate (AA) plus prednisone (P) and docetaxel (DOC) on patient-reported outcomes (PROs) in metastatic castration-naïve prostate cancer (mCNPC).

200 Background: AA + P added to androgen deprivation therapy (ADT) improved overall survival among newly diagnosed mCNPC patients (pts) with high-risk disease (HRD) vs placebos (PBOs) + ADT in the phase 3 LATITUDE study. Although ADT with or without chemotherapy is recommended in clinical guidelines as the mainstay of management for mCNPC, adding DOC to ADT does not consistently improve health-related quality of life (HRQoL). We performed an ITC to understand the relative impact of AA + P vs DOC on PROs in mCNPC pts. Methods: PROs were assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory (BPI). Mean change from baseline (BL) was based on differences in FACT-P and BPI scores between active vs control arms in LATITUDE (intention-to-treat [ITT] population) and CHAARTED (available data included mCNPC pts with high-volume disease [HVD] and low-volume disease [LVD]). Higher FACT-P score indicates better outcome/function; lower BPI score indicates better outcome/less pain. The probability of AA + P being better than DOC at 3, 6, 9, and 12 mos after treatment was based on fixed-effects Bayesian network meta-analysis. Results: Benefits in PROs with AA + P vs DOC were observed from 3 mos and sustained at least 1 year after treatment. Bayesian probability of AA + P being the better treatment for PROs ranged from 92.3% to 100%. Conclusions: Results from a Bayesian ITC suggest that AA + P was superior to DOC in improving PROs for at least 1 year after initiating treatment in men with mCNPC. In the absence of head-to-head trials, these analyses can provide useful insights on the relative impact of treatment options on HRQoL in mCNPC pts. Clinical trial information: NCT01715285. [Table: see text]

Real-world evidence in patient-related outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate plus prednisone (AA+P).

196 Background: Oral androgen biosynthesis inhibitor, abiraterone acetate plus prednisone (AA+P), has shown to improve survival and patient-related outcomes (PROs) in clinical trials. The COSMiC study (Canadian Observational Study in Metastatic Cancer of the Prostate; ClinicalTrials.gov: NCT02364531) set out to prospectively amass real-world data on mCRPC patients (pts) managed with AA+P in communities within Canada. Here, we report the interim analysis of their PROs. Methods: At planned data cutoff in Sept 2017 after a median follow-up of 33.8 months, 264 pts were enrolled in 39 sites across Canada. Their FACT-P (Functional Assessment of Cancer Therapy – Prostate) and MoCA (Montreal Cognitive Assessment) were evaluated at baseline as well as at weeks 12, 24, 48 and 72 after AA+P initiation. A 10-point decrease denotes clinically significant degradation in FACT-P and a total MoCA score of &gt; = 26 is considered normal. Descriptive analysis was utilized with continuous variables. Changes from baseline were summarized using mean (SD). Results: At a median age of 77 among 264 pts, 230, 185, 110 and 63 pts were available for analysis at their week 12, 24, 48, and 72 assessments respectively. The mean baseline FACT-P total score was 111.2 (19.44) with a &lt; 3-point absolute change from baseline at subsequent assessments, denoting no clinically significant change in functional status over time. The mean baseline MoCA score was 25.2 (4.50), yet all subsequent assessments scored above 26 and a mean absolute change from baseline of &lt; 1, showing an absence of cognitive decline over time. PSA value was available for 221 pts, 64.3% (142/221) and 34.4% (76/221) achieved a PSA decline of &gt; 50% and 90% respectively. All-grade treatment-related adverse events were reported in 63 pts, with 11% who have had AA+P discontinuation or interruption. Conclusions: COSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real world prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study, and underscores the importance of PRO utilization in this complex patient population. Clinical trial information: NCT02364531.