Quality of life considerations in the treatment of metastatic hormone-sensitive prostate cancer

2019 ◽  
Vol 20 (11) ◽  
pp. 1469-1471 ◽  
Author(s):  
Suzanne K Chambers ◽  
Mark Frydenberg ◽  
Jeff Dunn
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Hormone Sensitive

scholarly journals Quality of Life During Treatment With Chemohormonal Therapy: Analysis of E3805 Chemohormonal Androgen Ablation Randomized Trial in Prostate Cancer

2018 ◽  
Vol 36 (11) ◽  
pp. 1088-1095 ◽  
Author(s):  
Alicia K. Morgans ◽  
Yu-Hui Chen ◽  
Christopher J. Sweeney ◽  
David F. Jarrard ◽  
Elizabeth R. Plimack ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Chronic Illness ◽  
Functional Assessment ◽  
Brief Pain Inventory ◽  
Chronic Illness Therapy ◽  
Hormone Sensitive ◽  
Over Time ◽  
Time Point

Purpose Chemohormonal therapy with docetaxel and androgen deprivation therapy (ADT+D) for metastatic hormone-sensitive prostate cancer improves overall survival as compared with androgen deprivation therapy (ADT) alone. We compared the quality of life (QOL) between patients with metastatic hormone-sensitive prostate cancer who were treated with ADT+D and those who were treated with ADT alone. Methods Men were randomly assigned to ADT+ D (six cycles) or to ADT alone. QOL was assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P), FACT-Taxane, Functional Assessment of Chronic Illness Therapy-Fatigue, and the Brief Pain Inventory at baseline and at 3, 6, 9, and 12 months. The Wilcoxon signed rank test was used to examine changes over time. Mixed-effect models compared the QOL between arms at each time point. Results Seven hundred ninety men were randomly assigned (ADT+D [n = 397] and ADT[ n = 393]) and completed FACT-P (90% at baseline, 86% at 3 months, 83% at 6 months, 78% at 9 months, and 77% at 12 months). ADT+D patients reported a statistically significant decline in FACT-P at 3 months ( P < .001) but FACT-P did not differ significantly between baseline and 12 months ( P = .38). ADT+D FACT-P scores were significantly lower at 3 months ( P = .02) but significantly higher at 12 months ( P = .04) when compared with ADT FACT-P scores. Differences did not exceed the minimal clinically important difference at any time point. ADT+D patients reported significantly lower Functional Assessment of Chronic Illness Therapy-Fatigue scores at 3 months than did ADT patients ( P < .001). Over time, both arms reported significantly poorer FACT-Taxane scores ( P < .001) when compared with baseline. Brief Pain Inventory scores were similar between arms. Conclusion Although ADT+D was associated with statistically worse QOL at 3 months, QOL was better at 12 months for ADT+D patients than for ADT patients. Both arms reported a similar minimally changed QOL over time, suggesting that ADT+D is not associated with a greater long-term negative impact on QOL.

Radium-223 (Ra-223) versus novel antihormone therapy (NAH) for progressive metastatic castration-resistant prostate cancer (mCRPC) after 1 line of NAH: RADIANT, an international phase 4, randomized, open-label study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS5093-TPS5093
Author(s):  
Karim Fizazi ◽  
Aránzazu González del Alba ◽  
Özgüroğlu Mustafa ◽  
Iwona Anna Skoneczna ◽  
Heiko Krissel ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Adverse Events ◽  
Bone Metastases ◽  
Disease Progression ◽  
Group Performance ◽  
Short Form ◽  
Cross Resistance ◽  
Hormone Sensitive

TPS5093 Background: Men with mCRPC often receive sequential NAH (abiraterone and enzalutamide) despite reported cross-resistance, indicating a need for further life-prolonging options for progressive disease after prior NAH. Ra-223 is a targeted alpha therapy approved for mCRPC with symptomatic bone metastases based on the phase 3 ALSYMPCA study, in which it demonstrated significantly increased overall survival (OS), reduced symptomatic skeletal event (SSE) risk, improved quality of life, and reduced treatment-emergent adverse event rates vs placebo. As life-prolonging therapy is increasingly used in hormone-sensitive settings, this study has been designed to assess Ra-223 outcomes in patients with mCRPC that progressed after prior treatment with NAH and docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC) or mCRPC. Methods: This study is conducted in accordance with the Declaration of Helsinki, international ethical and good clinical practice guidelines, and local laws and regulations, with institutional review board/ethics committee approval at each site and written informed consent from patients before participation. This trial is registered with EudraCT: 2019-000476-42. Participants must be ≥18 years old, with an Eastern Cooperative Oncology Group performance status of 0/1; they must have mCRPC that progressed on/after ≥3 months of NAH for mHSPC or mCRPC and ≥2 cycles of docetaxel unless they refused or were ineligible, with ≥2 bone metastases on bone scan, no visceral metastases, and a worst pain score ≥1 on the Brief Pain Inventory-Short Form. Patients are randomized 1:1 to Ra-223 or NAH: Ra-223 55 kBq/kg intravenously every 4 weeks for 6 cycles or until disease progression, death, or withdrawal of consent if earlier; or abiraterone 1000 mg + prednisone 10 mg daily (if prior enzalutamide) or enzalutamide 160 mg daily (if prior abiraterone) until disease progression, death, or withdrawal of consent. NAH dosing may be modified to manage adverse events. Patients must use luteinizing hormone-releasing hormone analogs, if not surgically castrated, and bone health agents (bisphosphonates or denosumab) throughout the study. The primary endpoint is OS. Secondary endpoints are time to first SSE, radiologic progression-free survival, time to pain progression, adverse events, fracture incidence, and time to deterioration in quality of life (FACT-P total score). Using a test with a two-sided alpha of 0.05, 90% power, and randomization ratio of 1:1, approximately 508 events are required to detect a 33% increase in OS with Ra-223 vs NAH, assuming a median OS of 10 months with NAH. The expected study duration is 55 months, with a target of 696 patients to be randomized. The first patient was enrolled on November 9, 2020; 5 patients have been randomized and 2 have started treatment to date. Clinical trial information: 2019-000476-42.

scholarly journals A phase II randomized trial of observation versus stereotactic ablative radiation for oligometastatic prostate cancer (ORIOLE).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS5094-TPS5094
Author(s):  
Ryan Phillips ◽  
Noura Radwan ◽  
Ashley Ross ◽  
Steven P. Rowe ◽  
Michael A. Gorin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Phase Ii ◽  
Local Control ◽  
Definitive Treatment ◽  
Progression Rate ◽  
Type I ◽  
Free Survival ◽  
Hormone Sensitive

TPS5094 Background: ORIOLE is a randomized, non-blinded Phase II interventional study evaluating the safety and efficacy of SBRT in biochemically recurrent, oligometastatic, hormone-sensitive prostate cancer at 3 centers in the US. Patients will be stratified by clinical characteristics and randomized 2:1 to SBRT or observation. The primary clinical endpoint is progression at 6 months defined by PSA increase, radiologic or clinical evidence, ADT initiation, or death from any cause. Secondary endpoints include local control at 6 months, SBRT-associated toxicity and quality of life, and ADT-free survival. Imaging and laboratory correlates will characterize, in isolation, the effects of SBRT on oligometastatic disease. Methods: Eligible patients are hormone-sensitive, have undergone prior definitive treatment and recurred with 1-3 asymptomatic bone or soft tissue metastases diagnosed within 6 months, PSA doubling time (PSADT) < 15 months, ECOG performance status ≤ 2, and normal organ and marrow function. Minimization will be used to balance assignment by primary intervention, prior ADT, and PSADT. Accrual of 54 patients provides 85% power to detect a decrease in progression rate from 80% to 40% with type I error = 0.05 using one-sided Fisher’s exact test. Hazard ratios and Kaplan-Meier estimates of progression free survival, ADT free survival, and time to locoregional and distant progression will be calculated based on intention-to-treat. Local control will be assessed using RECIST 1.1 criteria. Withdrawal prior to 6 months will be counted as progression. Adverse events will be summarized and quality of life pre- and post-SBRT will be measured by Brief Pain Inventory. The investigational targeted imaging agent 18F-DCFPyL will be compared to bone scan and CT for identifying oligometastases before SBRT and monitoring disease response following SBRT. Biological alterations induced by SBRT will be investigated using circulating tumor cell analysis, deep sequencing of circulating tumor DNA, and T-cell repertoire profiling. A hereditary cancer assay will inform efforts to advance personalized screening and therapy. Clinical trial information: NCT02680587.

scholarly journals Health-Related Quality of Life in Metastatic, Hormone-Sensitive Prostate Cancer: ENZAMET (ANZUP 1304), an International, Randomized Phase III Trial Led by ANZUP

2021 ◽  
Author(s):  
Martin R. Stockler ◽  
Andrew J. Martin ◽  
Ian D. Davis ◽  
Haryana M. Dhillon ◽  
Stephen D. Begbie ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Cognitive Function ◽  
Physical Function ◽  
Health Related Quality ◽  
Free Survival ◽  
Related Quality ◽  
Health Related ◽  
Hormone Sensitive

PURPOSE We previously reported that enzalutamide improved overall survival when added to standard of care in metastatic, hormone-sensitive prostate cancer. Here, we report its effects on aspects of health-related quality of life (HRQL). METHODS HRQL was assessed with the European Organisation for Research and Treatment of Cancer core quality-of-life questionnaire and QLM-PR25 at weeks 0, 4, 12, and then every 12 weeks until progression. Scores from week 4 to 156 were analyzed with repeated measures modeling to calculate group means and differences. Deterioration-free survival was from random assignment until the earliest of death, clinical progression, discontinuation of study treatment, or a worsening of 10 points or more from baseline in fatigue, physical function, cognitive function, or overall health and quality of life (OHQL). HRQL scores range from 0 (lowest possible) to 100 (highest possible). RESULTS HRQL was assessed in 1,042 of 1,125 participants (93%). Differences in means favored control over enzalutamide for fatigue (5.2, 95% CI, 3.6 to 6.9; P < .001), cognitive function (4.0, 95% CI, 2.5 to 5.5; P < .001), and physical function (2.6, 95% CI, 1.3 to 3.9; P < .001), but not OHQL (1.2, 95% CI, −0.2 to 2.7; P = .1). Deterioration-free survival rates at 3 years, and log-rank P values comparing the whole distributions, favored enzalutamide over control for OHQL (31% v 17%; P < .0001), cognitive function (31% v 20%; P = .001), and physical function (31% v 22%; P < .001), but not fatigue (24% v 18%; P = .16). The effects of enzalutamide on HRQL were independent of baseline characteristics. CONCLUSION Enzalutamide was associated with worsening of self-reported fatigue, cognitive function, and physical function, but not OHQL. Enzalutamide was associated with improved deterioration-free survival for OHQL, physical function, and cognitive function because delays in disease progression outweighed early deteriorations in these aspects of HRQL.

386: Health Related Quality of Life in Low-Income, Uninsured Men with Prostate Cancer

2004 ◽  
Vol 171 (4S) ◽  
pp. 101-102
Author(s):  
Tracey L. Krupski ◽  
Arlene Fink ◽  
Lorna Kwan ◽  
Sarah Connor ◽  
Sally L. Maliski ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Low Income ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related
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