Hormonal Treatment-related Symptoms Research Articles

Changes in Quality of Life and Sexual Function After Luteinizing Hormone-Releasing Hormone (LHRH) Agonists and Orchiectomy in Men With Metastatic Prostate Cancer: Results From a Randomized Trial.

Purpose To examine changes in quality of life (QoL) in men diagnosed with metastatic prostate cancer undergoing androgen deprivation therapy (ADT). Methods This was a phase IV trial where patients were randomized to either triptorelin or subcapsular orchiectomy. We report changes in QoL, functional and symptom scales, and sexual function. These were assessed using the validated questionnaires, namely, the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (EORTC-QLQ-C30), European Organization of Research and Treatment of CancerQuality of Life Questionnaire Prostate Cancer 25 (EORTC-QLQ-PR25), and Erectile Hardness Scale (EHS) before treatment and at 12, 24, and 48 weeks, respectively. Data were analyzed using linear mixed models for repeated measures. Results Fifty-seven men with a median age of 74 years were randomized. The pooled analyses showed that QoL (p=0.003), emotional function (p<0.001), urinary symptoms (p=0.011), and hormonal treatment-related symptoms (p<0.001) changed significantly between visits. Improvement from baseline in QoL (mean change: 6.8 points (95% confidence interval (CI 95% CI): 2.1; 11.5)), emotional function (6.9 points: 3.3, 10.6), and urinary symptoms (-7.7 points (-12.3; -3.0)) was most pronounced at 24 weeks. Hormonal treatment-related symptoms (8.9 points (95% CI: 5.9; 12.0)) worsened. No significant differences between treatment groups were observed. At baseline, 29 men (51%) reported interest in sex, 18 were sexually active, and 12 had erections hard enough for penetration. At 48 weeks seven reported interest in sex, five were sexually active, and one man had a hard enough erection for penetration. Conclusions Men with newly diagnosed metastatic prostate cancer experience improved QoL and emotional function after starting ADT. Urinary symptoms improved, while hormonal treatment-related symptoms worsened. Interest in sex and sexual activity was retained in a proportion of men despite ADT.

Acute toxicity and quality of life in prostate cancer patients treated with definitive hypofractionated pelvic radiation therapy: a single-center report.

The objective was to report acute toxicity and quality of life in prostate cancer patients treated with definitive hypofractionated pelvic radiation therapy. Patients were designated candidates for hypofractionated pelvic radiation therapy if biopsy or imaging studies evidenced unfavorable intermediate-risk, high-risk or node-positive disease. Patients were treated using a regimen of 44 Gy to the nodal areas and simultaneous integrated boost of 60 Gy to the prostate in 20 fractions with CBCT-based imaging and volumetric arc therapy (VMAT). Patient data was obtained retrospectively; acute gastrointestinal (GI) and genitourinary (GU) toxicity was classified per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and obtained from clinical records. Quality of life was surveyed via phone call using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire QLQ-PR25. 78 patients were treated between May and December 2021. 83.33% of patients had high-risk disease, 16.67% had intermediate-risk disease, and 34.62% patients had node-positive disease. Median follow-up was 10.6 months. No patients presented acute grade >3 GI toxicity, and one patient presented grade 3 GU toxicity. 25.64% patients presented acute G2 GI toxicity and 17.95% patients presented acute G2 GU toxicity. 60.26% of patients responded to the EORTC-PR25 questionnaire. Mean scores for symptom scales were 11.26, 4.96 and 9.57 for Urinary Symptoms, Bowel Symptoms and Hormonal Treatment-Related Symptoms; mean scores for Sexual Activity and Functioning were 19.86 and 31.08, respectively. Definitive hypofractionated pelvic radiation therapy has an acceptable acute toxicity and QoL profile in this series of patients, although longer follow-up is needed to properly evaluate short and long-term toxicity. Further follow-up and patient recruitment is ongoing.

EQUINOXE study: Impact of relational cohesion and sexuality on the quality of life of patients treated with gonadotropin-releasing hormone agonist for prostate cancer.

ObjectivesTo measure the effect of dyadic adjustment on changes in patients’ quality of life when initiating treatment with gonadotropin‐releasing hormone (GnRH) agonist.Patients and methodsA prospective, multicenter, longitudinal, and non‐interventional study (NCT02630641) that included patients with prostate cancer starting GnRH agonist therapy, and their partners, in 157 centers in France. Data were collected at inclusion and after 6 months of treatment on quality of life (WHOQOL‐BREF), disease perception (B‐IPQ), disease symptoms (QLQ‐PR25), and perception of cohesion within the couple (dyadic adjustment, DAS‐16).ResultsThe Full Analysis Set included 492 patients (median age [Q1;Q3]: 74 [68;80] years). An improvement of the quality of life (defined as the improvement of at least one of the four dimensions of WHOQOL‐BREF) was reported in 290/434 (67%) patients between baseline and follow‐up. Quality of life was better at baseline and follow‐up in patients with good cohesion within the couple than in those with medium or poor cohesion. Factors associated with improvement in quality of life of patients were the following: initial presence of QLQ‐PR25 hormonal treatment‐related symptoms (OR [95% CI]: 3.00 [1.46, 6.17]) suggesting testosterone deficiency symptoms at baseline and initial low level (2.04 [1.12, 3.72]) or absence of sexual activity (2.23 [1.11, 4.50]) before GnRH agonist initiation.ConclusionMen with the greatest improvement in quality of life after initiating hormone therapy were those with, at baseline, testosterone deficiency symptoms (identified by QLQ‐PR25 treatment‐related symptoms score) or no/low sexual activity. Cohesion within the couple was not confirmed as an influence on the evolution of quality of life.

Effect of Exercise Adjunct to Radiation and Androgen Deprivation Therapy on Patient-Reported Treatment Toxicity in Men With Prostate Cancer: A Secondary Analysis of 2 Randomized Controlled Trials

PurposePhysical inactivity, in addition to clinical factors, has been associated with higher levels of late pelvic symptoms in patients with prostate cancer (PCa) after radiation therapy. The aim of this study was to investigate the effect of a structured multicomponent exercise program comprised of aerobic and resistance training as well as impact loading on the prevalence and severity of symptoms commonly resulting from androgen deprivation therapy (ADT) and pelvic radiation therapy. Methods and MaterialsWe performed a secondary analysis of pooled data from 2 randomized controlled trials that investigated the role of exercise on treatment-related side effects in patients with PCa receiving ADT. Patients were included in the analysis if they had undergone radiation therapy during the intervention in addition to ADT. Patient-reported quality of life and functional and symptom scales were assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 and PR25 before and after 6 months of exercise or usual care (UC). ResultsOne-hundred and fifteen patients with PCa receiving ADT, aged 47 to 84 years, who also underwent radiation therapy were included in the analysis (exercise, n = 72; UC, n = 43). There was a significant reduction in physical functioning (P = .019) and increased fatigue (P = .007) in the control group, with no change observed in the exercise group. Similarly, there was a trend toward reduced sexual activity in the control group (P = .064), with a mean adjusted change of -7.1 points. Furthermore, the prevalence of clinically important pain at 6 months was lower in the exercise group compared with UC (18.1 vs 37.2%, P = .022). No between-group differences were found for urinary (P = .473) or hormonal treatment-related symptoms (P = .552). ConclusionsExercise during concomitant hormone and radiation treatment for men with PCa may mitigate some adverse changes in patient-reported fatigue, physical functioning, and possibly sexual activity. The promotion and provision of exercise to counter a range of treatment-related adverse effects in patients with PCa undergoing radiation therapy and ADT should be actively encouraged.

Effects of leuprolide acetate on the quality of life of patients with prostate cancer: A prospective longitudinal cohort study.

PurposeThe aim of this study was to investigate the effect of androgen deprivation therapy (ADT) on the health-related quality of life (HRQOL) of patients with prostate cancer (PC) and compare the changes in the HRQOL between ADT alone and ADT plus intensity-modulated radiation therapy (IMRT).Materials and methodsPatients with PC were prospectively recruited between October 2018 and April 2020. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and the PC-specific module (PR25) were administered before ADT (baseline) and at 3, 6, and 12 months after ADT. All patients received subcutaneous injections of 45 mg leuprolide acetate at 6-month intervals for 12 months.ResultsFifty-five of the 71 patients (77.5%) completed the 12-month study. Twenty-two of the 55 patients received IMRT. There were no differences in the baseline characteristics with respect to IMRT. Compared with baseline, physical function and role function deteriorated after 3 months (p = 0.003, p = 0.019). However, the global quality of life (QOL) did not change over time. The symptom scales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire indicated that there was a statistically significant deterioration in dyspnea and fatigue symptoms at 12 months (p = 0.004, p = 0.004). Responses to the QLQ-PR25 revealed that patients experienced an increase in hormonal treatment-related symptoms after 3, 6, and 12 months (p = 0.002, 0.001, and 0.004). Comparisons between the ADT group and ADT plus IMRT group showed that body function and role function did not differ between the two groups (p = 0.815, p = 0.759), and there was also no difference in global QOL (p = 0.624).ConclusionOur results indicate that treatment with leuprolide acetate at 6-month intervals was not accompanied by changes in global QOL, despite deterioration of body and role functions and hormonal treatment-related symptoms. The combination of ADT and IMRT did not lead to additional deterioration in the HRQOL.

Effect of the exercise programme on the quality of life of prostate cancer survivors: A randomized controlled trial.

The aim of this study was to investigate the effect of the exercise programme on the quality of life of prostate cancer (PCa) survivors. A randomized controlled, parallel trial was conducted from April 2017 to January 2018 on 80 PCa survivors. They were randomly assigned to intervention and control groups (n = 40 in each group). The exercise programme was designed based on the self-management approach (SMA). The intervention group participated in a 12-week exercise programme consisting of one session of group exercise and three sessions of individual exercise per week using exercise facilities in the community. Data were collected using the quality of life questionnaires and the follow-up checklist. In the intervention group, statistically significant improvements in physical, role, emotional, social and sexual functions were reported. Also, the patients in this group reported reduced fatigue, insomnia, constipation, diarrhoea, urinary, bowel and hormonal treatment-related symptoms in comparison with before the exercise programme (p < 0.05). Nurses are suggested to plan for improving the participation of PCa survivors in exercise programmes using exercise facilities in the community in order to reduce the complications of treatment and improve their quality of life.

Prostate-specific health-related quality of life and patient-physician communication — A 3.5-year follow-up

ObjectiveThe aim of this study is to examine associations between prostate-specific health-related quality of life (HRQOL) and aspects of patient-physician communication in localized prostate cancer treatment. MethodsData of patients with localized prostate cancer were collected at 6-month intervals over a 3.5-year period within a prospective, observational study (HAROW). Data collection comprised D’Amico risk categories, the Charlson Comorbidity Index, patient-physician communication (information, shared decision making, support, devotion), and prostate-specific HRQOL (incontinence aid, urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual functioning, sexual activity). Data of N = 1722 patients undergoing radical prostatectomy were analyzed by longitudinal multilevel analysis. ResultsThe mean patient age was 65 years; 31% had a low risk and 38% an intermediate risk of cancer growth and spread; 73% had a Charlson Comorbidity Index of 0. Significant associations were found between prostate-specific HRQOL and shared decision making, support and devotion. Patient information was not significantly associated with aspects of prostate-specific HRQOL. ConclusionPatient reported long term outcomes are associated with aspects of patient-physician communication in prostate cancer patients. Patients feeling involved by their urologists experience less side effects of (surgical) treatment. Practice implicationsSpecial communication training programmes should be developed and implemented for urologists.

Impact of darolutamide (DARO) on pain and quality of life (QoL) in patients (Pts) with nonmetastatic castrate-resistant prostate cancer (nmCRPC).

5000 Background: DARO is a structurally distinct androgen receptor antagonist for which in vitro and phase 1/2 studies suggest low risk of adverse events (AEs) and drug–drug interaction. In the ARAMIS study of DARO in nmCRPC, metastasis-free survival (MFS) was significantly prolonged vs placebo (PBO) (40.4 vs 18.4 mo; hazard ratio [HR] 0.41; 95% confidence interval [CI] 0.34–0.50; P &lt; 0.001) and interim overall survival (OS) favored DARO (HR 0.71; 95% CI 0.50–0.99; P = 0.045). Methods: 1509 pts were randomized 2:1 to DARO 600 mg (two 300 mg tablets) twice daily (n = 955) or PBO (n = 554) while continuing androgen deprivation therapy (ADT). Primary endpoint was MFS. Secondary endpoints included OS and time to pain progression (assessed by Brief Pain Inventory Short Form). QoL was assessed by European Organisation for Research and Treatment of Cancer QoL Prostate Cancer module (EORTC-QLQ-PR25) at baseline (BL) and every 16 wks until end of treatment. Analysis of time to deterioration in EORTC-QLQ-PR25 subscales, defined as first occurrence of a minimally important difference (half the standard deviation of BL value), used Kaplan–Meier estimators and stratified Cox proportional hazard models. Results: DARO significantly delayed pain progression vs PBO (40.3 vs 25.4 mo; HR 0.65; 95% CI 0.53–0.79; P &lt; 0.001); this was maintained beyond end of study treatment. Time to deterioration of EORTC-QLQ-PR25 outcomes showed statistically and clinically significant delays with DARO vs PBO for urinary symptoms (25.8 vs 14.8 mo; HR 0.64; 95% CI 0.54–0.76; P &lt; 0.01). Time to deterioration of hormonal treatment-related symptoms was comparable with DARO vs PBO (18.9 vs 18.4 mo; HR 1.06; 95% CI 0.88–1.27; P = 0.52). DARO was well tolerated. Exposure-adjusted incidences (pts per 100 years’ exposure) of AEs of interest were similar/lower with DARO vs PBO (fatigue/asthenic conditions [11.3 vs 11.1], hypertension [4.7 vs 5.1], hot flush [3.7 vs 4.1], fracture [3.0 vs 3.5], falls [2.7 vs 4.1], cognitive disorder [0.3 vs 0.2], and seizure [0.2 vs 0.2]). Conclusions: For nmCRPC pts, DARO prolongs MFS, is well tolerated, maintains QoL, and delays worsening of pain and disease-related symptoms compared with PBO. Clinical trial information: NCT02200614.

Health-related quality of life in long-term survivors with localised prostate cancer by therapy-Results from a population-based study.

Several therapies for localised prostate cancer (PC) are available; all yield similar survival rates. However, each therapy has significant side effects that can influence patients' health-related quality of life (HRQoL) in the long run. The study sample included 911 survivors with localised PC, 5-15years post-diagnosis who were identified from the population-based CAESAR+study in Germany. HRQoL was assessed using the EORTC QLQ-C30 and EORTC QLQ-PR25 questionnaires. The association between type of therapy and HRQoL was assessed with multivariable linear regression and global F-test adjusting for age, time since diagnosis and comorbidities. Overall, survivors treated with radical prostatectomy (RP) or radiotherapy (RT) alone reported the best HRQoL and the lowest symptom burden. Conversely, survivors treated with androgen deprivation therapy (ADT) (& RP/RT) or RP & RT (in combination) reported the worst HRQoL and the highest symptom burden. Significant differences among treatment groups in HRQoL were found for global health status (p=0.041), social functioning (p=0.007), urinary symptoms (p=0.035), bowel symptoms (p=0.017) and hormonal treatment-related symptoms (p<0.001) among other symptoms. Long-term localised PC survivors formerly treated with a combination of RP and RT or with ADT report poorer HRQoL and more symptoms than patients treated with either RP or RT alone.

Association between urinary, bowel, and hormonal treatment-related symptoms and clinical outcomes in nonmetastatic castration-resistant prostate cancer (nmCRPC): PROSPER study.

233 Background: PROSPER data were analyzed to assess the relationship between time to worsening of urinary, bowel, and hormonal treatment-related symptoms and prostate-specific antigen (PSA) response, and the longitudinal association between symptom changes and metastasis-free survival (MFS). Methods: 1401 patients (pts) with nmCRPC at high metastasis risk were randomized 2:1 to enzalutamide (ENZA) or placebo. Urinary, bowel, and hormonal treatment-related symptoms were assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-PR25) at baseline (BL) and every 16 weeks. The association between time to first clinically meaningful symptom worsening and PSA response (≥50% decline from BL) was analyzed with stratified Cox regression using treatment as a covariate. Longitudinal symptom changes and MFS were evaluated in joint models using symptom scores as covariates, adjusted for treatment and clinical/demographic variables. The proportion of pts with improvement, no change, or deterioration at metastasis were analyzed by treatment group. Results: 723/1401 (52%) pts were PSA responders, including &gt;90% of ENZA pts. PSA responders were significantly less likely to develop urinary, bowel, and hormone treatment-related symptoms vs. non-responders (hazard ratio [HR] 0.58 [95% confidence interval 0.41, 0.81]; 0.59 [0.43, 0.80]; and 0.70 [0.51, 0.97], respectively). Every 9-point increase in urinary symptom score was associated with a 10% increased metastasis risk (HR 1.1 [1.05, 1.15]). Bowel and hormonal symptoms did not predict metastasis. Most pts reported no EORTC score changes at metastasis and maintained stable urinary/bowel symptoms, with no major observed symptom differences between treatment groups. Conclusions: ENZA delays metastasis and extends time to symptom worsening. A ≥50% PSA reduction from BL is associated with a reduction in risk for urinary, bowel, and hormonal treatment-related symptom worsening; changes in urinary symptoms from BL also predict metastases. Clinical trial information: NCT02003924 (PROSPER).

Quality of life after low-dose rate-brachytherapy for prostate carcinoma \u2013 long-term results and literature review on QLQ-C30 and QLQ-PR25 results in published brachytherapy series

BackgroundPatient-reported health-related quality of life (HRQOL) differs between treatment options for prostate carcinoma. Long-term HRQOL data in brachytherapy series are scarce. Therefore, we analyzed prostate-specific and general HRQOL in patients treated with brachytherapy for prostate carcinoma after long-term follow-up.MethodsTwo hundred ninety-six patients with prostate carcinoma were treated with brachytherapy (01/1998–11/2003). General and prostate-specific HRQOL were measured using EORTC-QLQ-C30 and EORTC-QLQ-PR25, respectively. Patients were asked to complete the questionnaires after a median follow-up of 141 (119–181) months. QLQ-C30 results were compared to the German reference population. QLQ-PR25 results were compared to an earlier follow-up after a median of 51 months (no published QLQ-PR25 reference population for comparison). Additionally, a literature review on HRQOL data in brachytherapy series was performed.ResultsOne hundred six (35.8%) patients were lost to follow-up, 70 (23.6%) had died. 120 (40.5%) patients were contacted. 80 questionnaires were returned (27% of the original cohort; 91% of alive patients were ≥70 years). Sexual activity declined over time (mean scores: 40.5 vs. 45.5; p = 0.006), hormonal treatment-related symptoms, problems associated with incontinence aids, and burden of obstructive urinary symptoms did not differ significantly compared to the 51-month follow-up. General HRQOL was numerically better in our cohort as compared to the German reference population (> 16% relative difference for both age strata; < 70 and ≥70 years).ConclusionsOur results indicate that symptom-burden after long-term follow-up and associated prostate-specific HRQOL remains relatively stable from 51 to 141 months. General HRQOL in surviving patients was numerically better compared to the reference population.

PD28-01 TESTOSTERONE LOWERING, PSA RESPONSE AND QUALITY OF LIFE IN PATIENTS WITH ADVANCED HORMONE SENSITIVE PROSTATE CANCER RECEIVING TAK-385, AN ORAL GNRH ANTAGONIST: PHASE 2 INTERIM ANALYSIS

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) I1 Apr 2016PD28-01 TESTOSTERONE LOWERING, PSA RESPONSE AND QUALITY OF LIFE IN PATIENTS WITH ADVANCED HORMONE SENSITIVE PROSTATE CANCER RECEIVING TAK-385, AN ORAL GNRH ANTAGONIST: PHASE 2 INTERIM ANALYSIS Neal D. Shore, James L. Bailen, Christopher Pieczonka, Daniel R. Saltzstein, Paul R. Sieber, David B. MacLean, Hongliang Shi, Hélène M. Faessel, Huamao Mark Lin, Yanyan Zhu, and Fred Saad Neal D. ShoreNeal D. Shore More articles by this author , James L. BailenJames L. Bailen More articles by this author , Christopher PieczonkaChristopher Pieczonka More articles by this author , Daniel R. SaltzsteinDaniel R. Saltzstein More articles by this author , Paul R. SieberPaul R. Sieber More articles by this author , David B. MacLeanDavid B. MacLean More articles by this author , Hongliang ShiHongliang Shi More articles by this author , Hélène M. FaesselHélène M. Faessel More articles by this author , Huamao Mark LinHuamao Mark Lin More articles by this author , Yanyan ZhuYanyan Zhu More articles by this author , and Fred SaadFred Saad More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.388AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES TAK-385 is an investigational, oral, non-peptide GnRH antagonist in late phase 2 evaluation for the management of hormone sensitive prostate cancer (HSPC). Two trials are ongoing: TAK-385 120 mg daily (QD) vs degarelix for patients (pts) requiring 6-mos neoadjuvant/adjuvant to EBRT (NCT02135445) and continuous TAK-385 80 or 120 mg QD vs leuprorelin (LEU) for advanced PC (relapse post local treatment or M1; NCT02083185; reported here). METHODS Pts aged ≥18 yrs with biopsy-confirmed PC, baseline testosterone (T) >150 ng/dL and PSA >2 ng/mL, and candidates for first-line androgen deprivation therapy, were randomized to receive oral TAK-385, 80 or 120 mg, QD or LEU 22.5 mg SC Q12 wks, for 48 wks. The primary endpoint was effective castration rate (T <50 ng/dL) at all scheduled visits from wk 5-24. Secondary endpoints included safety, PK, PSA response and quality of life (QoL). RESULTS At the second interim analysis (May 2015), 92% of 75 pts in the 2 TAK-385 arms (median age 73 yrs) achieved sustained castration rates (wk 5-24) vs 95% of 20 pts in the LEU arm (median age 68.5 yrs). Median T levels after 3 days of TAK-385 fell to castrate levels (36.9 ng/dL) vs the expected T flare (648.1 ng/dL) with LEU. After 2 wks, median T with TAK-385 achieved castration levels of <20 ng/dL and from wk 5-24 most pts in all arms maintained median T~10 ng/ dL. Consistent with the onset and depth of T lowering, PSA50 after 4 wks was 81% (TAK-385) and 20% (LEU). After 24 wks, median PSA reduction was 97.3% (0.1 ng/mL, TAK-385) vs 92.4% (0.2 ng/mL, LEU). Global QoL scores after 24 wks were similar across arms (mean decrease of 6.9 points [p=0.004] from baseline score of 81.4 for TAK-385 vs 7.4 points [p=0.131] from 79.6 for LEU. Most pronounced, significant changes from baseline occurred in 2 EORTC QLQ-PR25 subscales (sexual activity and hormonal-treatment related symptoms) and were similar across arms. TAK-385 safety profile is consistent with medical castration with to date no identified significant off-target toxicity. All-grade adverse events occurred in 91% vs 95% pts (TAK-385 vs LEU); the most common were hot flush (59/60%) and fatigue (21/15%). PK analysis showed dose-proportional plasma trough levels over >6 mos consistent with phase 1 results. CONCLUSIONS As a GnRH antagonist with rapid T and PSA response, the long term tolerability, efficacy and QoL of TAK-385 appear comparable to LEU. A phase 3 study of TAK-385, as an option to injectable GnRH therapies for PC pts, is planned. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e654 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Neal D. Shore More articles by this author James L. Bailen More articles by this author Christopher Pieczonka More articles by this author Daniel R. Saltzstein More articles by this author Paul R. Sieber More articles by this author David B. MacLean More articles by this author Hongliang Shi More articles by this author Hélène M. Faessel More articles by this author Huamao Mark Lin More articles by this author Yanyan Zhu More articles by this author Fred Saad More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

OLIGOPELVIS – GETUG P07, a multicentre phase II trial of combined salvage radiotherapy and hormone therapy in oligometastatic pelvic node relapses of prostate cancer: Preplanned analysis of acute toxicity.

173 Background: We explored the role of salvage pelvic radiotherapy combined with LH-RH agonists in pelvic oligometastatic patients (pts) detected by 18F-choline positron-emission tomography (FCH-PET) imaging in biochemically relapsing prostate cancer patients following radical therapy. We report a preplanned analysis of acute toxicity and quality of life after the first 20 pts. Methods: Biochemically relapsing prostate cancer pts with 1-5 FCH-PET positive oligometastatic pelvic lymph nodes received high-dose image-guided intensity-modulated radiation therapy (RT: pelvic lymph nodes 54 Gy, 30 f; FCH-PET-positive lymph nodes 66 Gy, 30 f; prostate bed 66 Gy, 33 f; if FCH-PET-positive prostate bed relapse 72 Gy, 36 f) combined with 6 months LH-RH agonists. Primary objective was biochemical-clinical failure-free survival. After the first 20 pts, a preplanned analysis of toxicity at 1 months after RT completion was conducted. Stopping criteria were more than 10 or 2 pts experiencing grade 2 or 3 toxicity respectively. Changes in toxicity (NCI-CTC AE v4), and quality of life (EORTC QLQ-C30 and PR25 questionnaires) over time were analyzed by the Wilcoxon signed-rank test. Results: 20 pts (median age 62) presenting oligometastatic pelvic lymph nodes (mean 1.7) received RT to lymph nodes in all pts and to the prostate bed in 8 pts with a boost to a local relapse in 2 pts. Grade 2 gastrointestinal and genitourinary toxicity was noted in 4/20 and 0/20 pts respectively during radiotherapy that resolved completely in all pts one month after treatment. No grade 3 toxicity was noted. At 1 month, significant worsening was reported by pts for 4/21 QoL items but the worsening was clinically relevant ( &gt; 10 points) for 2 items only: fatigue and dyspnea. However, there was significant - but clinically non-relevant ( &lt; 10 points) - worsening of physical functioning and hormonal-treatment related symptoms. Conclusions: High-dose RT to the pelvis and oligometastatic lymph nodes did not increase acute toxicity. As per protocol, the study resumed and is now recruiting 50 more patients. Clinical trial information: NCT02274779.

Long-term quality of life in high-risk prostate cancer: Results of a phase III randomized trial.

5 Background: To evaluate long-term quality of life (QOL) in 630 patients with high-risk prostate cancer (HRPC) treated in a prospective randomized phase III trial (PCS IV clinical trials, Gov. # NCT 00223171). Methods: Patients were randomized to radiotherapy (RT) plus 36 or 18 months of androgen deprivation therapy (ADT). QOL was assessed by two validated tools: EORTC30 (30 items) and PR25 (25 items). The 55 items were regrouped into 21 scales: 15 for EORTC30 and six for PR25. All items and scales scores were linearly transformed to a 0 to 100 points scale. A p value less than 0.01 was considered statistically significant and a difference between groups in mean scores of greater than or equal to 10 points as clinically relevant. Patient-reported outcomes were filled out before treatments, every six months during ADT, four months after and then once a year for five years. All items and scales scores were analysed with general linear model with repeated measures to evaluate changes between groups and over time periods. Results: Three hundred ten patients were randomized to 36 months and 320 to 18 months of ADT, with a median follow-up of 79 months, there was no difference in survival outcomes. The global adherence to QOL questionnaires was 72.4% (10,052 out of 13,880). When comparing the two groups, 6 out of 21 scales (physical, emotional, and social functioning, fatigue, hormonal treatment-related symptoms, and sexual active) and 14 out of 55 items (trouble with long walks, stay in bed during the day, weakness, tenseness, worry, irritable, depressed, close to a toilet, blood in stools, hot flushes, enlarged breasts, interested in sex, sexually active, enjoyable sex) were statistically significant (p&lt; 0.01) in favor of the 18 months ADT group. None of the 21 scales reached clinical relevance (mean scores greater than or equal to 10 points) sexual active being the highest score with 9.0 points of difference. For the 14 statistically significant items, interest in sex with 9.9 points and sexually active with 8.1 points were close to clinical relevance and hot flushes with 24 points and enjoyable sex with 18 points had important clinical relevance at 42 months. Conclusions: In HRPC treated with RT and ADT, reducing the duration of ADT from 36 to 18 months improves QOL, without a negative impact on survival. Source of Funding: AstraZeneca Pharmaceuticals grant. Clinical trial information: PCS IV clinical trials, Gov. # NCT 00223171.

Burden of Illness in Prostate Cancer Patients with a Low-to-Moderate Risk of Progression: A One-Year, Pan-European Observational Study.

Objective. To assess the impact of low-to-moderate risk prostate cancer on patients' quality of life (QoL) at diagnosis and within the first year of treatment. Subjects and Methods. Men (n = 672) aged 50–75 years with prostate cancer (Gleason score ≤7, PSA ≤20 ng/mL and clinical staging T1c–T2b) were enrolled in five European countries. Patients completed five questionnaires, including EORTC Quality of Life Questionnaire—Prostate Cancer 25 (QLQ-PR25) and EORTC Quality of Life Questionnaire—Cancer 30 (QLQ-C30). Questionnaires were completed at baseline, at 3 months and 12 months after starting treatment. The primary endpoint was the change in QLQ-PR25 urinary symptoms subscale score from baseline to the assessment at 3 months. Results. Mean (SD) age was 65.0 (5.7) years and 400 (66%) men had Gleason score ≤6 prostate cancer. The most frequently used initial treatment was radical prostatectomy (71% of patients). QLQ-PR25 urinary symptoms subscale score was significantly increased at 3 months (P < 0.001), indicating that urinary symptoms worsened after treatment. The score was lower at 12 months than at 3 months, but it was still significantly higher than at baseline (P < 0.001). Hormonal treatment-related symptoms, sexual functioning, and sexual activity scores significantly worsened at 3 and 12 months (all P < 0.001). For the QLQ-C30 questionnaire, global health status/QoL score significantly decreased at month 3 but was not different from baseline by month 12. Scales for physical, role, and social functioning, and fatigue, showed significant deterioration at 3 and 12 months. Conclusions. Low-to-moderate risk prostate cancer may have a substantial effect on patients' QoL within one year following treatment.

Patient Reported Outcome Measure (PROM) of Quality of Life After Prostatectomy - Results from a 5-Year Study

Prostate cancer is the most common cancer among men in Sweden, and treatment is negatively affecting the patients' quality of life. Even so, long term experiences are sparse and implications for nursing practice are little known. The aim of this study was to determine areas of functioning and factors impacting quality of life, QOL, during and five years after radical prostatectomy (RP) using a quality of life questionnaire and a specific module for prostate cancer. A longitudinal study was performed with consecutively included Swedish men from baseline and after RP treatment (n=222) from 2003 to 2011 to obtain their opinions on quality of life. Data was gathered through a mail out - mail in procedure at baseline, 3 months, 1-3 and 5 years after treatment with a response rate of 94.14% - 75.2%. One reminder was sent on each occasion. Identified areas with increased functioning after five years were emotional and social functioning. QOL ratings did not change over the years. Sexual activity and functioning decreased and hormonal treatment-related symptoms increased. Impact on QOL was found regarding emotional and social functioning, nausea/vomiting, pain and hormone-related symptoms. Increasing age, living with a partner and educational level had no significant impact on QOL. Implications for nursing are to initially focus on physical problems and at times for follow-up visits pay attention also to emotional and social aspects of life. To be able to make a difference in the patient’s life, nurses need to bridge the gap between in-hospital treatment and everyday life outside hospital.

Cross-Cultural Application of the Korean Version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients with Prostate Cancer - EORTC QLQ-PR25

Objective: We evaluated the psychometric properties of the Korean version of the European Organization for Research and Treatment of Cancer QLQ-PR25 when applied to Korean prostate cancer (PC) patients. Methods: A total of 172 patients who underwent curative radical prostatectomy (RP) with or without adjuvant androgen deprivation therapy were asked to complete the Korean version of the EORTC QLQ-C30 and PR25 questionnaires 3 times (before and 3 and 6 months after RP). Psychometric evaluation of the questionnaire was conducted. Results: Multitrait scaling analysis showed satisfactory construct validity in most scales except for bowel symptoms and hormonal treatment-related symptoms. Internal consistency tested by Cronbach's α coefficient met the 0.70 criterion for the urinary symptom, sexual activity and sexual functioning scales at the all 3 time points. Known-group comparison analyses showed better quality-of-life (QOL) scores in patients with higher performance status, and higher hormonal treatment-related symptom scores in patients on hormonal treatment. Responsiveness to changes was in line with clinical implications over time after RP. Conclusions: Our results show that the EORTC QLQ-PR25 questionnaire has adequate levels in cross-cultural validity. The Korean version of the EORTC QLQ-PR25 is a generally reliable and robust instrument for the assessment of various QOL aspects that can be self-administered to Korean PC patients undergoing RP.

Reliability and Validity of the Taiwan Chinese Version of the EORTC QLQ-PR25 in Assessing Quality of Life of Prostate Cancer Patients

This study examined the psychometric properties and clinical validity of the EORTC QLQ-PR25, a questionnaire for assessing the quality of life of patients with prostate cancer. The Taiwan Chinese version of the prostate cancer module (EORTC QLQ-PR25) and the core questionnaires (EORTC QLQ-C30) were administered to 81 patients with prostate cancer after they had been treated with surgery or hormone therapy or both. The QLQ-PR25 module assesses urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual activity and sexual functioning. The questionnaires were well accepted by the patients and very few of the items had missing data. Only the urinary symptom scale showed satisfactory internal consistency. Scales were able to differentiate clinical groups of patients with corresponding symptoms, but the differences were smaller than that of major functioning scales in the core questionnaire. The Taiwan Chinese version of the EORTC QLQ-PR25 is acceptable in patients with prostate cancer in Taiwan, able to differentiate corresponding symptoms, but the scale structure needs further improvement.