Qualitative study to understand the emotional response to a metastatic diagnosis in castration-resistant prostate cancer.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 201-201
Author(s):  
Claire Burbridge ◽  
Jason A Randall ◽  
Tara Symonds ◽  
Joe Lawson ◽  
Lindsay Dearden ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Emotional Response ◽  
Additional Treatment ◽  
Emotional Impact ◽  
Castration Resistant Prostate Cancer ◽  
Support Person ◽  
Castration Resistant ◽  
Experienced Pain ◽  
The Us ◽  
Recent Diagnosis

201 Background: To explore the emotional response of men with a recent metastatic Castration Resistant Prostate Cancer (mCRPC) diagnosis, emotional burden of monitoring their condition prior to additional treatment for metastasis (“watch and wait”), and emotional impact on caregivers. Methods: In-depth, qualitative, one-to-one interviews with 25 men with a recent diagnosis of mCRPC from the US (n = 4), France (n = 12) and Germany (n = 9). Additional interviews were conducted with 12 of the participants’ primary support person (PSP) - a friend/family member who provided support to the participants emotionally and/or in everyday tasks; US (n = 2), France (n = 8), Germany (n = 4). Interviews were audio-recorded, transcribed and thematic analyzed. Results: Participants were 54-85 years old; 88% retired; mean time since metastatic diagnosis was 7.5 months (seven were within 12 weeks of metastasis, all others within 24 months of metastasis); and 19 experienced pain related to their CRPC. Symptoms and impacts associated with mCRPC were consistent across countries. The most frequent symptoms (reported by ≥75%) were fatigue/tiredness, sexual dysfunction and pain. Metastasis had a negative emotional impact, participants reported fear of what happens next. Some explicitly associated certain symptoms/impacts with metastasis, such as localized pain, diarrhea, blood in stool, and increased impact of activities of daily living. 72% highlighted that metastatic diagnosis impacted their emotional state, experiencing worry, anxiety, fear, low mood/depression and shock, with increased burden on PSP and strain on relationships. 80% highlighted that monitoring PSA values was important, and ten discussed the emotional impact of this: fear and worry when rising; glad, happy, and excited when falling. Most participants (80%) reported that, if a medication had been available to them to delay metastasis, they would have taken it, even if asymptomatic. Conclusions: Metastatic diagnosis was associated with a worsening of symptoms and both physical and emotional impacts. Rising PSA levels prior to metastasis had a negative emotional impact. Most participants were willing to take a medication to delay metastasis.

scholarly journals Treatment characteristics for nonmetastatic castration-resistant prostate cancer in the United States, Europe and Japan

2019 ◽  
Vol 15 (35) ◽  
pp. 4069-4081 ◽  
Author(s):  
Ruchitbhai Shah ◽  
Marc Botteman ◽  
Reginald Waldeck
Keyword(s):  
Prostate Cancer ◽  
Eastern Cooperative Oncology Group ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
Castration Resistant Prostate Cancer ◽  
Androgen Synthesis ◽  
Castration Resistant ◽  
The Us ◽  
Androgen Synthesis Inhibitors

Aim: We conducted this study to describe nonmetastatic castration-resistant prostate cancer (nmCRPC) patient characteristics and treatment patterns in the US, Europe and Japan. Materials & methods: Descriptive analyses were conducted using the 2015–2017 Ipsos Global Oncology Monitor Database. Results: A total of 2065 (442 in the US, 509 in Europe and 1114 in Japan) patients (median age: 74–80 years; stage III at diagnosis : 38.5%; Eastern Cooperative Oncology Group [ECOG] score ≤1: 79.4%; treated by urologist : 88.4%) were included in the analytic cohort. Luteinizing hormone-releasing hormone agonists and antiandrogens were the most commonly used first regimen treatments. With subsequent nmCRPC regimens their use decreased, while the use of chemotherapy, corticosteroids, androgen synthesis inhibitors and second-generation androgen receptor inhibitors increased. Conclusion: These data represent real-world treatment patterns in nmCRPC.

scholarly journals Incidence of Skeletal-Related Events in Patients with Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

2019 ◽  
Vol 2019 ◽  
pp. 1-7 ◽  
Author(s):  
Alison Tse Kawai ◽  
David Martinez ◽  
Catherine W. Saltus ◽  
Zdravko P. Vassilev ◽  
Montse Soriano-Gabarró ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Incidence Rate ◽  
Incidence Rates ◽  
Negative Consequences ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistance ◽  
Castration Resistant ◽  
The Us ◽  
History Of ◽  
Skeletal Related Events

Background and Objective. Skeletal-related events (SREs) are common in men with bone metastases and have negative consequences for patients with castration-resistant prostate cancer (CRPC), including pain, reduced quality of life, and increased mortality. We estimated incidence rates of first SREs in a cohort of men with CRPC in the Surveillance, Epidemiology, and End Results-Medicare database. Methods. We included men aged ≥ 65 years with a prostate cancer diagnosis in 2000-2011 if they had no prior malignancy (other than nonmelanoma skin cancer) and had surgical or medical castration with subsequent second-line systemic therapy, which was used to infer castration resistance. The first occurrence of an SRE (fracture, bone surgery, radiation therapy, or spinal cord compression) in Medicare claims was identified. Incidence rates of SREs were estimated in all eligible person-time and, in secondary analyses, stratified by any use of bone-targeted agents (BTAs) and history of SRE. Results. Of 2,234 men with CRPC (84% white, mean age = 76.6 years), 896 (40%) had an SRE during follow-up, with 74% occurring within a year after cohort entry. Overall, the incidence rate of SREs was 3.78 (95% CI, 3.53-4.03) per 100 person-months. The incidence rate of SREs before any BTA use was 4.16 (95% CI, 3.71-4.65) per 100 person-months, and after any BTA use was 3.60 (95% CI, 3.32-3.91) per 100 person-months. The incidence rate in patients with no history of SRE was 3.33 (95% CI 3.01-3.68) per 100 person-months, and in patients who had such a history, it was 4.20 (95% CI 3.84-4.58) per 100 person-months. Conclusions. In this large cohort of elderly men with CRPC in the US, SREs were common. A decrease in incidence of SREs after starting BTA is suggested, but the magnitude of the effect may be confounded by indication and other factors such as age and prior SRE.

Treatment patterns in men with castration-resistant prostate cancer receiving docetaxel.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e15165-e15165 ◽  
Author(s):  
Keith L. Davis ◽  
Benjamin Gutierrez ◽  
Teresa Maria Zyczynski ◽  
James A. Kaye
Keyword(s):  
Prostate Cancer ◽  
Standard Of Care ◽  
Bone Lesions ◽  
Routine Practice ◽  
Case Report Form ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Patterns Of Use ◽  
The Us ◽  
Visceral Metastases

e15165 Background: Docetaxel has been a standard of care for castration-resistant prostate cancer (CRPC) in the US since 2004 (TAX 327), yet little has been reported on its patterns of use in routine practice. To help understand these patterns, a retrospective study was conducted and is reported here. Methods: Medical records from 394 patients treated in the US were reviewed: 48 from oncology (N=344) and 8 from urology (N=50) practices. Inclusion criteria were: CRPC diagnosed between 2004 and 2010; received docetaxel; discontinued docetaxel due to rising PSA, progression of bone lesions, or progression of nodal or visceral metastases. Data were collected from physicians using an internet-based case report form. We evaluated patient demographics, characteristics of the docetaxel regimen and other treatments used until docetaxel discontinuation. Results: Patients had a mean [±SD] age of 66.5 [8.9] years, the majority (63%) were white, and geographic dispersion was similar to the US population. The majority of patients initiated docetaxel between 2008 and 2010. After CRPC diagnosis, 8% of patients initiated another cancer-directed therapy before starting docetaxel. Most (78.9%) patients initiated docetaxel with prednisone, while 18.5% initiated docetaxel alone and 2.6% initiated with other drugs. Half of patients initiated docetaxel within 1 month after CRPC diagnosis, while 25% started ≥6 months later. Other non-chemotherapy treatments used with docetaxel were hormonal therapy (22.8%), radiotherapy (17.3%), and surgery (4.1%). Most patients (75%) received ≥4 docetaxel cycles, half received ≥6 cycles, 25% received ≥8 cycles and 10% received ≥10 cycles. Increased tumor mass, with/without new bone lesions or rising PSA, was the most common reason for docetaxel discontinuation (74% of patients). Conclusions: Concordant with guidelines, docetaxel and prednisone was the preferred first-line chemotherapy regimen in CRPC patients. However, one quarter of patients did not initiate docetaxel until ≥6 months after CRPC diagnosis and total exposure varied considerably, with only 10% receiving ≥10 cycles. Future studies are needed to describe specific reasons for docetaxel delay and sub-maximal exposure in some CRPC patients.

Efficacy of additional chemotherapy following failure of currently approved therapies in patients with castration-resistant prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 274-274
Author(s):  
Luca Campedel ◽  
Paul Blanc-Durand ◽  
Sandra Assoun ◽  
Cristian Mateescu ◽  
Morgan Roupret ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Median Overall Survival ◽  
Additional Treatment ◽  
Gleason Grade ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistance ◽  
Visceral Involvement ◽  
Castration Resistant ◽  
Additional Chemotherapy

274 Background: Approved therapies for patients with castration resistant prostate cancer (CRPC) include next generation androgen receptor inhibitors as well as taxanes which are given sequentially. After failure of these drugs, physicians may use additional chemotherapy such as carboplatin, paclitaxel, mitoxantrone and vinorelbine. The clinical benefit of these drugs in this setting remains fully unknown. Methods: A retrospective monocentric study of patients treated for CRPC was performed. Presence of metastasis and visceral involvement at diagnosis and at castration resistance, time between start of hormonotherapy and castration resistance were recorded as well as several clinical and biological parameters at start of CRPC first line. The cohort was divided into two groups according to the use of additional chemotherapies following failure of currently approved therapies. Results: Fourty subjects out of 138 cases (28.9%) fulfilled the inclusion criteria. At diagnosis, median patients age was 68 years (range, 53-86), median Gleason grade was 8 (6-10) and 53% of them harbored distant metastasis. At castration-resistance stage, 93% were metastatic including 27% out of them wihich harbored visceral involvement. Median overall survival (OS) of patients since castration-resistance was 34.9 months (range, 7.4-88.0). The two groups were comparable in terms of age, PSA level, and Gleason grade. Median OS for patients in the additional chemotherapy group (n = 16) was 42.4 months as compared to 37.3 months in the non additional treatment group (n = 24), with no statistical difference (p = 0.961). Main treatments administered consisted of carboplatin (n = 6), paclitaxel (n = 4) and mitoxantrone (n = 4). PSA response rate (decrease > 50%) obtained with use of additional treatment was 12%. Median progression-free survival was 1.9 months (range, 0.7-13.1) and median overall survival was 4.2 months (range, 2.2-17.8). Conclusions: Our retrospective study suggests that additional treatment after standard treatment failure for CRPC is associated with limited benefit. Further studies are needed to clarify the role of new agents therapies in this setting.

DAROL: DARolutamide ObservationaL study patients in nonmetastatic castration-resistant prostate cancer (nmCRPC) patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS5593-TPS5593
Author(s):  
Evan Y. Yu ◽  
Christopher Michael Pieczonka ◽  
Alberto Briganti ◽  
Declan G. Murphy ◽  
Thierry Lebret ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Real World ◽  
Specific Antigen ◽  
Clinical Effectiveness ◽  
Phase Iii ◽  
Castration Resistant Prostate Cancer ◽  
Event Time ◽  
Castration Resistant ◽  
The Us

TPS5593 Background: Patients (pts) with prostate cancer treated with prolonged androgen deprivation therapy (ADT) will eventually develop castration-resistant disease. Treatment of pts with nmCRPC with darolutamide (DARO) delays the development of metastases, which are associated with cancer-related morbidity. DARO is a structurally unique oral androgen receptor inhibitor approved by the FDA for the treatment of nmCRPC, based on prolonged metastasis-free survival (MFS) compared with placebo (median 40.4 months vs.18.4 months, respectively) in the ARAMIS phase III clinical trial. DARO showed a similar incidence of adverse events (AEs) compared to ADT alone and has a low potential for drug-drug interactions. However, phase III clinical trials cannot fully reflect all the facets of real-world pts. Therefore, non-interventional studies in the real-world setting, such as DAROL, are able to provide additional insight into the patterns of use and real-world safety profile of recently approved drugs. Methods: (NCT04122976) will enrol participants in the US, Brazil, Japan, and the EU. Eligible pts include men with histologically confirmed nmCRPC aged ≥18 yrs, life expectancy ≥3 months, and initiated on DARO treatment as per investigators’ decision within 3 days prior to enrollment. DAROL opened for enrollment in December 2019 in the US with a projected enrollment of 1000 pts. The primary endpoint of DAROL is safety. Treatment-emergent AEs will be collected during the study. Secondary endpoints to measure clinical effectiveness are MFS, time to symptomatic skeletal event, time to prostate-specific antigen progression, survival rate, and duration of DARO therapy. Other endpoints include pt demographics and characteristics, and prior and subsequent therapy. The estimated primary completion date is December 30, 2024. Clinical trial information: NCT04122976 .

scholarly journals Incidence of second primary malignancies in metastatic castration-resistant prostate cancer: results from observational studies in three countries

2020 ◽  
Vol 16 (25) ◽  
pp. 1889-1901
Author(s):  
Zdravko P Vassilev ◽  
Montse Soriano Gabarró ◽  
James A Kaye ◽  
Catherine W Saltus ◽  
Oliver Riedel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Claims Data ◽  
Second Primary ◽  
Research Database ◽  
Castration Resistant Prostate Cancer ◽  
Cancer Data ◽  
Castration Resistant ◽  
The Us ◽  
Second Primary Malignancies ◽  
Medicare Database

Aim: This reports some of the first incidence rate (IR) estimates of second primary malignancies (SPMs) in men with metastatic castration-resistant prostate cancer (mCRPC) in three countries. Patients & methods: Claims data from the German Pharmacoepidemiological Research Database; registry data from the Prostate Cancer Data Base Sweden; and combined registry-claims data from the US Surveillance, Epidemiology and End Results-Medicare database were analyzed to obtain overall survival and incidence of SPMs in men with mCRPC. Results: SPMs occurred in 308 German (n = 2360), 273 Swedish (n = 2849) and 172 US (n = 2234) men with mCRPC. IRs of SPMs were 79.0 (95% CI: 70.4–88.4), 101.7 (95% CI: 90.3–114.5) and 59 (95% CI: 50–68) per 1000 person-years in German, Swedish and US cohorts, respectively. Conclusion: These studies report some of the first IR estimates of SPMs in men with mCRPC, providing a historical risk estimate of SPM in this patient population.

scholarly journals 661P Real-world treatment (Tx) patterns of metastatic castration-resistant prostate cancer (mCRPC) patients (pts) in the US

2020 ◽  
Vol 31 ◽  
pp. S534-S535
Author(s):  
N. Shore ◽  
F. Laliberté ◽  
R. Ionescu-Ittu ◽  
A. Gayle ◽  
S. Amin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
The Us
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