scholarly journals Clinical outcomes, management, and treatment patterns in patients with metastatic castration‐resistant prostate cancer treated with radium‐223 in community compared to academic settings

The Prostate ◽  
2021 ◽  
Author(s):  
Oliver Sartor ◽  
Sreevalsa Appukkuttan ◽  
Jeffrey Weiss ◽  
Che‐Kai Tsao
Keyword(s):  
Prostate Cancer ◽  
Clinical Outcomes ◽  
Treatment Patterns ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Radium 223 ◽  
Academic Settings ◽  
Outcomes Management

The TRUMPET registry: Assessing clinical outcomes and quality of life in patients with castration-resistant prostate cancer and their caregivers.

2016 ◽  
Vol 34 (3_suppl) ◽  
pp. 241-241
Author(s):  
Scott C Flanders ◽  
Daniel W. Lin ◽  
Lawrence Ivan Karsh ◽  
Daniel H. Shevrin ◽  
Neal D. Shore ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Outcomes ◽  
Work Productivity ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant

241 Background: Patient care in castration-resistant prostate cancer (CRPC) is complex, with varying treatment patterns due to differences in therapies, patient characteristics, and physician practices. The impact of such patterns on clinical outcomes and quality of life (QoL) represent a contemporary medical issue. This study aims to improve the understanding of clinical outcomes and QoL of patients with CRPC and their caregivers. Methods: TRUMPET is a prospective, observational, multi-center study of patients with CRPC in the United States. Approximately 2000 patients and their caregivers (if eligible) will be enrolled over 24 months from IRB-approved urology and oncology sites. Eligible patients with CRPC include those with life expectancy of ≥ 6 months initiating the first active course of anti-cancer treatment for M0 or M1. A 48-month observation period will follow the last patient enrolled. Primary objectives are to describe longitudinal patterns of care, disease assessment methods, treatment decisions, treatment settings, physician referral patterns, and CRPC patient characteristics associated with these. Patient-reported health-related QoL (HRQoL) instruments will assess the effects of CRPC and its management on patient perception of key aspects of HRQoL. The following will be administered at baseline and follow-up: SF-12v2 Health Survey, Functional Assessment of Cancer Therapy–Prostate, Brief Pain Inventory-Short Form, and Memorial Anxiety Scale for Prostate Cancer (prostate-specific antigen anxiety subscale). In a patient sub-study, work productivity and treatment satisfaction will be described using the Work Productivity and Activity Impairment (WPAI) Questionnaire: Specific Health Problem and Service Satisfaction Scale for Cancer Care. Caregiver QoL and productivity will be captured with the Caregiver Quality of Life Index–Cancer and the Caregiver-modified WPAI Questionnaire. Results: As of August 21, 2015, 60 sites were active, with 63 patients and 39 caregivers enrolled. Conclusions: Outcomes from the TRUMPET study will describe treatment patterns, QoL, and health care resources associated with patient management in CRPC. Clinical trial information: NCT02380274.

The National Radium-223 Dichloride Audit Group: Data from patients in United Kingdom oncology centers with metastatic castration-resistant prostate cancer treated with radium-223 dichloride.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 59-59
Author(s):  
Manreet Randhawa ◽  
Irene Stratton ◽  
Robert J. Jones ◽  
Keyword(s):  
Prostate Cancer ◽  
Final Analysis ◽  
Outcome Data ◽  
Treatment Patterns ◽  
Quality Data ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Radium 223 ◽  
The Uk ◽  
Ecog Ps

59 Background: Clinicians in 20 UK oncology centres comprise the National Radium-223 Dichloride Audit group which is evaluating treatment patterns and outcomes in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with Radium-223 dichloride (Xofigo). Methods: Pts first treated with Xofigo from September 2017 were included and demographics, treatment, clinical, biochemical and outcome data collected prospectively. Analysis was carried out using frequency tables, univariate and survival analysis. Results: We report the outcomes on the first 100 pts in 4 centres with good quality data. Median values of each characteristic including 25th and 75th percentiles are as follows: Age at diagnosis = 67 years (62-72), weight = 83.5kgs (73.6-92.8), Hb = 139g/L (118 – 136), WCC = 7.3X109/L (5.7 – 8.7), plt count = 252x109/L (208 – 290), ALP = 128U/L (96-263) and PSA = 42.1ug/L (21.5 – 125.7). A majority of pts had an ECOG PS of 0-1. The number of pts having Xofigo as 1st, 2nd, 3rd and 4th line treatment was 15, 64, 20 and 1 respectively. There was a statistically significant decline in median weight, Hb, WCC, plt count and ALP and a rise in PSA between cycle 1 and cycle 6. Thirty eight pts did not complete 6 cycles with 31 of these (82%) discontinuing due to disease progression. The prevalence of adverse events was 5% (20/100). Twenty nine pts had a skeletal event by 12 months. There was no change in the WHO analgesic score, QOL scores or ECOG PS between treatment 1 and 6. Thirty nine pts had subsequent lines of treatment with 31 of these having only 1 line of treatment. Median overall survival was 363 days (95% CI 312-426 days). Conclusions: The ongoing National Radium-223 Dichloride Audit records data from approximately 600 mCRPC pts treated across the UK in routine clinical NHS care. To our knowledge, it is the first prospective analysis of such pts and the largest in assessing treatment patterns, outcomes and quality of life data in addition to standard biochemical and clinical parameters. Further multivariate analysis will be presented and the implications of the licensing change of Xofigo will be illustrated in the final analysis.

scholarly journals Early alkaline phosphatase dynamics as biomarker of survival in metastatic castration-resistant prostate cancer patients treated with radium-223

2021 ◽  
Author(s):  
Maarten J. van der Doelen ◽  
Agnes Stockhaus ◽  
Yuanjun Ma ◽  
Niven Mehra ◽  
Jeffrey Yachnin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Alkaline Phosphatase ◽  
Confidence Interval ◽  
Surrogate Marker ◽  
Response Monitoring ◽  
Castration Resistant Prostate Cancer ◽  
Related Event ◽  
Castration Resistant ◽  
Radium 223 ◽  
Skeletal Related Event

Abstract Purpose Radium-223 is a life-prolonging therapy for castration-resistant prostate cancer (CRPC) patients with symptomatic bone metastases. However, validated biomarkers for response monitoring are lacking. The study aim was to investigate whether early alkaline phosphatase (ALP) dynamics after the first radium-223 injection can act as surrogate marker for overall survival (OS). Methods This retrospective multicenter study included consecutive CRPC patients treated with radium-223. Patients were divided into four subgroups based on baseline ALP level (normal/elevated) and early ALP response, defined as ≥10% ALP decrease after the first radium-223 injection. Primary endpoint was OS among the subgroups. Secondary endpoints included time to first skeletal-related event, time to ALP progression, and treatment completion rate. Results A total of 180 patients were included for analysis. Median OS was 13.5 months (95% confidence interval 11.5–15.5). Patients with elevated baseline ALP without ALP response after the first injection had significantly worse OS when compared to all other patients (median OS 7.9 months versus 15.7 months, hazard ratio 2.56, 95% confidence interval 1.73–3.80, P < 0.001). Multivariate analysis demonstrated that elevated baseline ALP without ALP response after the first injection, the number of prior systemic therapies, baseline LDH level, and baseline ECOG performance status were prognostic factors of OS. Patients with elevated baseline ALP without ALP response after the first injection had significantly shorter times to ALP progression and first skeletal-related event, and more frequently discontinued radium-223 therapy when compared to other patients. Conclusion Early treatment–induced changes in ALP after one radium-223 injection were associated with OS in metastatic CRPC patients.

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