Physician-reported comorbidities and treatment management in patients with non-metastatic castration-resistant prostate cancer.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 149-149
Author(s):  
Sreevalsa Appukkuttan ◽  
Bindi Patel ◽  
Jacqueline Parkin ◽  
Dena H. Jaffe ◽  
Jonathon Wright ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Online Survey ◽  
Poor Mental Health ◽  
Castration Resistant Prostate Cancer ◽  
Treatment Practice ◽  
Treatment Management ◽  
Patient Profile ◽  
The Past ◽  
Castration Resistant ◽  
The Impact

149 Background: With the emergence of potent therapies in non-metastatic castration-resistant prostate cancer (nmCRPC) there is a need to understand the impact of nmCRPC treatments on patient comorbidities and concomitant medications. The goal of this study was to understand treatment management of nmCRPC in patients with pre-existing comorbidities from a physician perspective. Methods: Physicians who treated nmCRPC patients with systemic therapy were recruited from a US physician panel for an online survey (Sept-Oct 2019). Physician responses included physician treatment practice, demographic characteristics, and their 'typical' nmCRPC patient profile from the past 6 months (e.g., health profile, disease management, and quality of life [QOL]). Results: Fifty US physicians (56% urologists, 44% oncologists) with 21±6 years in practice, treated on average 30 nmCRPC patients in the past 6 months. The most common nmCRPC treatments were leuprolide acetate (82%), enzalutamide (80%) and apalutamide (70%). The most common comorbidities reported were hypertension (96%), sexual dysfunction (94%), diabetes (92%), myocardial infarction (88%) and urinary issues (88%). 78% of the physicians reported taking comorbidities and medications for comorbidities into consideration when prescribing nmCRPC treatments. Between 15%-28% of physicians reported a change in nmCRPC prostate treatment and 19%-26% reported a dose change in nmCRPC treatment for up to 1/3 of their patients due to comorbidities (Table). For QOL, urologists versus oncologists indicated more days with poor health status among nmCRPC patients (e.g., median poor mental health days 30-days prior to treatment: urologists=15 days vs oncologists=5 days). Conclusions: Many physicians take into account pre-existing comorbidities and their medications when prescribing nmCRPC treatments. Differences in perceived QOL were observed between physician specialty. These findings highlight the importance of considering therapies that lessen the treatment burden in nmCRPC. [Table: see text]

scholarly journals Impact of Extraskeletal Metastases on Skeletal-Related Events in Metastatic Castration-Resistant Prostate Cancer with Bone Metastases

Cancers ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 2034
Author(s):  
Soraia Lobo-Martins ◽  
Arlindo R. Ferreira ◽  
André Mansinho ◽  
Sandra Casimiro ◽  
Kim Leitzel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Bone Metastases ◽  
Unmet Need ◽  
Bone Alkaline Phosphatase ◽  
Multicenter Clinical Trial ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Therapeutic Landscape ◽  
Skeletal Related Events ◽  
The Impact

The therapeutic landscape of metastatic castration-resistant prostate cancer (mCRPC) has substantially evolved over the last decade. Nonetheless, a better understanding of bone-targeted agents (BTAs) action in mCRPC remains an unmet need. Theuse of BTAs aims to reduce the incidence of skeletal-related events (SREs) in patients with mCRPC. Less frequent BTA schedules are currently being studied to minimize adverse events. In this study, the impact of metastatic compartment (bone and extraskeletal metastases (BESM) vs. bone-only metastases (BOM)) on bone biomarker kinetics, time to first on-study SRE, and symptomatic skeletal events (SSEs) is evaluated. This is a retrospective analysis of the prospective, randomized, multicenter clinical trial of denosumab vs. zoledronic acid in patients with mCRPC and bone metastases. A total of 1901 patients were included, 1559 (82.0%) with BOM and 342 with BESM (18.0%). Bone metastases burden was balanced between groups. Baseline levels and normalization rates of corrected urinary N-terminal telopeptide and bone alkaline phosphatase did not differ between groups. However, BESM patients had a higher risk of SREs (adjusted HR 1.21; 95% CI 1.01–1.46; p = 0.043) and SSEs (adjusted HR 1.30; 95% CI 1.06–1.61; p = 0.014). This difference was more pronounced in the first 12 months of BTA treatment.In mCRPC, strategies of BTA schedule de-escalation may take into account presence of extraskeletal metastases.

scholarly journals The impact of statin use on the efficacy of abiraterone acetate in patients with castration-resistant prostate cancer

The Prostate ◽  
2017 ◽  
Vol 77 (13) ◽  
pp. 1303-1311 ◽  
Author(s):  
Lauren C. Harshman ◽  
Lillian Werner ◽  
Abhishek Tripathi ◽  
Xiaodong Wang ◽  
Benjamin L. Maughan ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
The Impact ◽  
Statin Use

A prospective randomized phase II trial evaluating maintenance GM-CSF in an intermittent chemotherapy (chemo) regimen for metastatic castration-resistant prostate cancer (mCRPC): A DoD prostate cancer clinical trials consortium trial.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 35-35
Author(s):  
Eric Jay Small ◽  
Vivian K. Weinberg ◽  
Charles J. Ryan ◽  
Celestia S. Higano ◽  
Amy Mimi Lin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Optimal Number ◽  
Castration Resistant Prostate Cancer ◽  
Time To Progression ◽  
Gm Csf ◽  
Castration Resistant ◽  
Randomized Phase Ii ◽  
Intermittent Chemotherapy ◽  
Number Of Cycles ◽  
The Impact

35 Background: The optimal number of cycles of docetaxel for patients (pts) with mCRPC is not known, and in practice, treatment breaks are common. The current study was designed to test the safety and efficacy of utilizing 6 cycles of standard docetaxel with chemo free intervals in patients who achieve and maintain a response to docetaxel. Methods: Pts with mCRPC, no prior chemo, and KPS > 60% were eligible. Pts were treated with “induction” docetaxel 75 mg/m2 q 3 weeks, and prednisone 5 mg po bid. PSAWG1 criteria were used to define response and progression. After 6 cycles, responding pts stopped chemo and were randomized to observation (Obs) or to GM-CSF, 250 mcg/m2 daily for 14 days out of every 28-day cycle. Pts were followed with monthly PSA and imaging every 2 cycles until progression, at which point docetaxel was reinitiated for another 6 cycles, followed by the same “off chemo” regimen. The primary endpoint was the time to progression while on chemo (time to chemo resistance). Results: 114 pts have been enrolled: 3 are undergoing induction, and 111 are therefore evaluable. Of these pts, 82 completed induction, (10 did not due to PD, 9 due to adverse events (AE), 10 due to pt or MD choice). Of 111 evaluable pts, 48 (43%) had a response to chemo and were eligible for randomization. 22 were randomized to Obs and 26 to GM-CSF. Of 48 randomized pts, 25 restarted chemo, all for PSA PD. (23 pts did not re-start chemo because of AE, other therapy being started, or pt choice; 1 pt is still on GM-CSF.) 6/25 (24%) pts experienced a response to the 2nd series of chemo, and 1/6 (17%) to the 3rd. The time to chemo re-initiation (n=25) was 3.1 mos in Obs pts and 4.2 mos in GM-CSF pts. Conclusions: 43% of patients met criteria for undergoing intermittent chemo. The response proportion to the 1st, 2nd, and 3rd series of docetaxel was 43%, 24% and 17%, respectively. GM-CSF may modestly delay the time to chemo re-initiation, but the sample size is small and insufficient to assess the impact of GM-CSF on time to chemo resistance.

A phase III, randomized, double-blind, placebo-controlled study of enzalutamide in men with nonmetastatic castration-resistant prostate cancer: Post-hoc analysis of PROSPER by prior therapy.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 185-185
Author(s):  
Ugo De Giorgi ◽  
Eleni Efstathiou ◽  
William R. Berry ◽  
Heather Ann Payne ◽  
Katarzyna Madziarska ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Hormonal Therapy ◽  
Phase Iii ◽  
Controlled Study ◽  
Castration Resistant Prostate Cancer ◽  
Targeting Therapy ◽  
Prior Therapy ◽  
Castration Resistant ◽  
Bone Targeting ◽  
The Impact

185 Background: Men with nonmetastatic castration-resistant prostate cancer (nmCRPC) are at high risk of developing metastatic CRPC. In the primary analysis of PROSPER, enzalutamide (ENZA) provided a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) in men with nmCRPC. Here we report the impact of prior therapy on MFS. Methods: Eligible men with nmCRPC, prostate-specific antigen (PSA) doubling time ≤ 10 months, and PSA ≥ 2 ng/mL at screening continued androgen deprivation therapy and were randomized 2:1 to ENZA 160 mg or placebo (PBO). The primary endpoint was MFS. Results: 1401 men were enrolled, with a median age of 74 y (range, 50-95 y). In all men, ENZA reduced the risk of metastasis or death by 71% (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.24-0.35; P < .0001). The treatment effect consistently favored ENZA regardless of whether men had prior bilateral orchiectomy, prior radiation, ≤1 or > 1 prior hormonal therapy, or prior bone-targeting therapy (Table). Men who received > 1 prior hormonal therapy had a shorter median MFS than those who received ≤1 line of hormonal therapy (5 months and 3 months in the ENZA and PBO groups, respectively). Conclusions: In men with nmCRPC and rapidly rising PSA, ENZA treatment resulted in a clinically meaningful reduction in the risk of developing metastases or death irrespective of prior surgery, radiation, or bone-targeting therapy. MFS was longer in men who had received ≤1 prior hormonal therapy. Clinical trial information: NCT02003924. [Table: see text]

Colina 111 PET results in a nonmetastatic castration-resistant cancer (nmCRPC) in population that is negative by conventional imaging: True incidence from real-world evidence data.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17522-e17522
Author(s):  
Martin Pitzzu ◽  
Luciana Gennari ◽  
Norberto Olguin ◽  
Gustavo Jankilevich
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Drop Out ◽  
Conventional Imaging ◽  
Castration Resistant Prostate Cancer ◽  
True Incidence ◽  
Castration Resistant ◽  
Real World Evidence ◽  
Metastatic Setting ◽  
The Impact

e17522 Background: Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC) is characterized by a rising prostate-specifing antigen (PSA) level, castrate testosterone levels,and no evidence of distant metastases by conventional bone scan and croos-sectional image of the chest,abdomen and pelvis. SPARTAN and PROSPER trials recently demonstrated metastasis free survival in patients with nmCPRC treated with apalutamide with androgen blockade therapy and enzalutamide respectively, Real incidence of nmCPRC in latinoamerican population is unknown. Therefore, patients with negative conventional imaging could be metastatic with PET use, fall the percentage of non metastatic setting PET Colina demonstrated improved sensitivity and specificity used for biochemically recurrent hormone – sensitive patients and staging advanced disease. Colina – PET performance in nmCPRC remain largely unknown and requires evaluation. In this study we examined the incidence of nmCPRC in an Argentinian population by conventional imaging studies and the impact of use of Colina Pet. Methods: Overall 300 patients from public and private insitutions were assessed. Real World Evidence Prostate cancer database were retrospectively screened for records of patients with nmCPRC. Results: Three hundred medical records of consecutive patients with prostate cancer were assessed. All patients were evaluated by multidisciplinary team Localized disease 214 patients and metastatic Prostate Cancer Castration Sensitive 86 patients. With a median a six years of median follow up, 43 patients developed Prostate Cancer Castration Resistant. Six patients showed nmCPRC criteria, in all of them Colina Pet was indicated. After PET colina 5 cases were positives and only one patient were negative. Conclusions: The incidence or nmCPRC is 0,02% in argentine cohort and drop out to 0,003% with PET use. Colina-PET detected loco-regional of M1 disease in nearly all patients with CPRC and no detectable metastasis by conventional imaging. Further epidemiologic with real world evidence data studies with cost-efective evaluations should be launched to put in context the rol of PET in this setting.

Meta-analysis of randomized trials to study the impact of prednisone on toxicities and survival in metastatic castration-resistant prostate cancer.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 28-28
Author(s):  
Gurudatta Naik ◽  
Charity Morgan ◽  
Matt D. Galsky ◽  
William K. Oh ◽  
Guru Sonpavde
Keyword(s):  
Prostate Cancer ◽  
Randomized Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Oral Prednisone ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Number Of Patients ◽  
Meta Analyses ◽  
The Impact

28 Background: The impact of daily oral prednisone (P) on toxicities and outcomes in men with metastatic castration-resistant prostate cancer (mCRPC) is unclear. We conducted a meta-analysis of randomized trials comparing regimens that included P in only one arm. Methods: PubMed, conferences and clinicaltrials.gov databases were searched for articles reported from January 1966 to June 2013. Eligible studies were selected in an unbiased manner and limited to randomized trials enrolling patients with mCRPC and comparing regimens administering P in only one arm. Data extraction was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Arms containing P were compared with arms without P for severe toxicities grade 3 or higher and overall survival (OS). Results: Five randomized trials were published or presented with P in only one arm: by Scher and colleagues comparing docetaxel (D) plus P versus D plus DN101 (n=953), by Higano and colleagues comparing DP versus GVAX (n=621), by Small and colleagues comparing DP versus GVAX plus D (n=394), by Fossa and colleagues comparing P versus flutamide (n=201) and by Petrylak and colleagues comparing mitoxantrone plus P versus D plus estramustine phosphate (n=770). The total number of patients was 2,939, of whom 1,471 received therapy not containing P and 1,468 received therapy containing P. All five trials were eligible for analysis of toxicities, but the Fossa trial was excluded for the OS analysis due to lack of required parameters. There was no difference between the non-P and P groups for severe toxicities (incidence rate ratio [IRR] = 0.82, p = 0.712, I2 = 97.9%). When examining toxicities as a reason for discontinuing therapy, the non-P groups were not different from the P groups (relative risk [RR] = 1.24, p = 0.413, I2 = 86.8%). The non-P groups demonstrated no difference in OS compared to the P groups (HR = 1.09, p = 0.531, I2= 79.7%). The meta-analysis is limited by the trial level design and small number of patients and does not exclude a favorable palliative impact of P. Conclusions: This meta-analysis of randomized trials in mCRPC suggests no significant impact on severe toxicities and OS with the use of daily oral prednisone.

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