scholarly journals Differences in Toxicity and Outcomes in Clinical Trial Participants From Minority Populations

2021 ◽  
pp. 1-5
Author(s):  
Matthew Labriola ◽  
Daniel J. George
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Adverse Event ◽  
Racial Disparities ◽  
Black Men ◽  
Racial Differences ◽  
Androgen Deprivation Therapy ◽  
White Men ◽  
Androgen Deprivation ◽  
The Impact

Black men have a higher prevalence of and mortality rate from prostate cancer compared with White men and have been shown to present with more aggressive and later-stage disease. How prostate cancer treatment affects these racial disparities is still unclear. Several studies have shown that Black men who receive treatment have a more pronounced decrease in prostate cancer–specific death; however, there remains a large disparity in all-cause mortality. This disparity may be in part related to a higher risk of death resulting from comorbidities, given the higher rates of cardiovascular disease and diabetes in Black men, both of which are complicated by the use of androgen-deprivation therapy. To further understand these disparities, it is important that we analyze the racial differences in adverse event rates and severity. Increasing the percentage of Black men in clinical trials will improve the understanding of the biologic drivers of racial disparities in prostate cancer. To evaluate the potential differences in adverse event reporting and demonstrate the feasibility of enrolling equal numbers of Black and White men in trials, we performed a prospective, multicenter study of abiraterone plus prednisone with androgen-deprivation therapy in men with metastatic castration-resistant prostate cancer, stratified by race. Racial differences in prostate-specific antigen kinetics and toxicity profile were demonstrated. Higher rates and severity of adverse events related to adrenal hormone suppression, including hypertension, hypokalemia, and hypomagnesemia, were seen in the Black cohort, not previously reported. Increased enrollment of Black men in prostate cancer clinical trials is imperative to further understand the impact of race on clinical outcomes and treatment tolerability.

Association of black race with improved outcomes following definitive radiotherapy with androgen deprivation therapy for high-risk prostate cancer: A meta-analysis of eight randomized trials.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 327-327
Author(s):  
Amar Upadhyaya Kishan ◽  
Tahmineh Romero ◽  
Matthew Rettig ◽  
Isla Garraway ◽  
Mack Roach ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Black Men ◽  
Androgen Deprivation Therapy ◽  
Randomized Trials ◽  
Meta Analysis ◽  
White Men ◽  
Androgen Deprivation ◽  
Definitive Radiotherapy

327 Background: Though Black men with prostate cancer are more likely to have aggressive disease features than White men, race-specific differences in initial treatment responses in localized disease remains unknown. Methods: Individual patient data were obtained for 9259 patients (including 1674 [18.1%] Black men and 7585 [81.9%] White men) enrolled on eight randomized controlled trials evaluating definitive radiotherapy (RT) ± short-term or long-term androgen deprivation therapy (STADT and LTADT). The primary endpoints were biochemical recurrence (BCR), distant metastasis (DM), and prostate cancer-specific mortality (PCSM). Fine-Gray subdistribution HR (sHR) models were developed to evaluate the cumulative incidences of all endpoints after stratification by National Comprehensive Cancer Network risk grouping. A meta-analysis was done to estimate pair-wise comparisons of treatments within and between Black and White men, after adjusting for age, Gleason score, clinical T stage, and initial PSA. Results: Black men were more likely to have NCCN high-risk disease at enrollment (656/1674 [39.2%] vs 2506/7585 [33%], p<0.001). However, within the high-risk stratum Black men had lower 10-year rates of BCR (46.1% vs. 50.4%, p=0.02), DM (14% vs. 21.6%, p<0.001), and PCSM (4.9% vs. 9.8%, p<0.001). After adjusting for age and disease characteristics, Black men with high-risk prostate receiving RT+STADT had lower rates of BCR (sHR 0.73, 95% CI 0.62-0.86, p<0.001), DM (sHR 0.64, 95% CI 0.49-0.84, p=0.001) and PCSM (sHR 0.49, 95% CI 0.25-0.95, p=0.04). There were no differences in BCR, DM, or PCSM among men receiving RT+LTADT. The interaction between race and the impact of adding STADT to RT alone on BCR was statistically significant (p=0.003). Conclusions: Black men enrolled on randomized trials with long-term follow-up have higher risk disease at enrollment, but have better BCR, DM, and PCSM outcomes with RT-based therapy compared with White men, particularly with the addition of STADT.

scholarly journals Cognitive decline in patients with prostate cancer: study protocol of a prospective cohort, NEON-PC

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043844
Author(s):  
Natalia Araujo ◽  
Samantha Morais ◽  
Ana Rute Costa ◽  
Raquel Braga ◽  
Ana Filipa Carneiro ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cognitive Decline ◽  
Cognitive Performance ◽  
Androgen Deprivation Therapy ◽  
Survival Rates ◽  
Cardiovascular Complications ◽  
Androgen Deprivation ◽  
High Survival ◽  
The Impact

IntroductionProstate cancer is the most prevalent oncological disease among men in industrialised countries. Despite the high survival rates, treatments are often associated with adverse effects, including metabolic and cardiovascular complications, sexual dysfunction and, to a lesser extent, cognitive decline. This study was primarily designed to evaluate the trajectories of cognitive performance in patients with prostate cancer, and to quantify the impact of the disease and its treatments on the occurrence of cognitive decline.MethodsParticipants will be recruited from two main hospitals providing care to approximately half of the patients with prostate cancer in Northern Portugal (Portuguese Institute of Oncology of Porto and São João Hospital Centre), and will comprise a cohort of recently diagnosed patients with prostate cancer proposed for different treatment plans, including: (1) radical prostatectomy; (2) brachytherapy and/or radiotherapy; (3) radiotherapy in combination with androgen deprivation therapy and (4) androgen deprivation therapy (with or without chemotherapy). Recruitment began in February 2018 and is expected to continue until the first semester of 2021. Follow-up evaluations will be conducted at 1, 3, 5, 7 and 10 years. Sociodemographic, behavioural and clinical characteristics, anxiety and depression, health literacy, health status, quality of life, and sleep quality will be assessed. Blood pressure and anthropometrics will be measured, and a fasting blood sample will be collected. Participants’ cognitive performance will be evaluated before treatments and throughout follow-up (Montreal Cognitive Assessment and Cube Test as well as Brain on Track for remote monitoring). All participants suspected of cognitive impairment will undergo neuropsychological tests and clinical observation by a neurologist.Ethics and disseminationThe study was approved by the Ethics Committee of the hospitals involved. All participants will provide written informed consent, and study procedures will be developed to ensure data protection and confidentiality. Results will be disseminated through publication in peer-reviewed journals and presentation in scientific meetings.

scholarly journals Clinical Utility of miRNA-1, miRNA-29g and miRNA-133s Plasma Levels in Prostate Cancer Patients With High-Intensity Training After Androgen-Deprivation Therapy

2019 ◽  
pp. S139-S147
Author(s):  
A. GAZOVA ◽  
A. SAMAKOVA ◽  
E. LACZO ◽  
D. HAMAR ◽  
M. POLAKOVICOVA ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Body Composition ◽  
Exercise Training ◽  
Androgen Deprivation Therapy ◽  
Plasma Levels ◽  
Exercise Intervention ◽  
Free Testosterone ◽  
Androgen Deprivation ◽  
Control Group ◽  
The Impact

The randomized trials showed that the addition of training resistance program to androgen-deprivation therapy (ADT) had many beneficial effects for prostate cancer (PC) patients (significant protective effect on the volume of muscle mass) and the studies have revealed a panel of miRNAs, which are deregulate in PC and may serve as promising biomarkers of PC risk. The primary aim of our present study was to investigate the effect of exercise training to changes in body composition (muscle strength) and the secondary endpoint was to investigate the impact of an exercise training program on plasma levels of selected myogenic microRNAs (miRNAs) (miRNA-1, miRNA-29b, and miRNA-133) in PC patients undergoing the ADT. Effect of ADT and exercise intervention showed significant increase (experimental group vs. control group) the changes in body composition, free testosterone levels, IL-6 and plasma levels of myogenic miRNAs and significant reduced insulin serum levels. In conclusion, resistance training with ADT in the treatment of PC significantly changed the physical and metabolic function and the plasma levels of specific myogenic miRNAs. Our data support with the other publicized results.

scholarly journals Decreased Risk of Renal Calculi in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer

2020 ◽  
Vol 17 (5) ◽  
pp. 1762 ◽  
Author(s):  
Chien-Yu Lin ◽  
Jui-Ming Liu ◽  
Chun-Te Wu ◽  
Ren-Jun Hsu ◽  
Wen-Lin Hsu
Keyword(s):  
Prostate Cancer ◽  
Androgen Deprivation Therapy ◽  
Lower Risk ◽  
Propensity Score Analysis ◽  
Renal Calculi ◽  
Androgen Deprivation ◽  
Research Database ◽  
Cox Regression Analysis ◽  
The Impact ◽  
Subsequent Risk

Renal calculi are common, with male predilection and androgen exposure potentially increasing the risk of renal calculi. Systemic effects of androgen deprivation therapy (ADT) have been observed but the influence of ADT on renal calculi in prostate cancer (PCa) patients is not fully understood. We conducted this population-based study to evaluate the impact of ADT on the subsequent risk of renal calculi. We used the National Health Insurance Research Database of Taiwan to analyze the incidences of renal calculi in ADT patients and non-ADT patients from 2001 to 2013. In total, 3309 patients with PCa were selected. After matching with 1:1 propensity-score analysis, 758 ADT patients with 758 matched non-ADT controls were enrolled in the final analysis. Demographic characteristics were analyzed and Cox regression analysis for calculating the hazard ratios (HR) was performed for the subsequent risk of renal calculi. Finally, 186 (186/1516, 12.3%) patients with diagnosed renal calculi were detected. ADT patients had a lower risk of subsequent renal calculi with an adjusted HR of 0.38 (7% vs. 17.5%, 95% confidence interval (CI) 0.28–0.53; p < 0.001) in comparison with the non-ADT group. The Kaplan–Meier curve showed significant differences of cumulative incidences of renal calculi. In conclusion, ADT patients had approximately one-third lower risk of subsequent renal calculi. Further studies are warranted to evaluate the clinical significance.

Recent Developments in Androgen Deprivation Therapy for Locally Advanced Prostate Cancer

2014 ◽  
Vol 10 (02) ◽  
pp. 133
Author(s):  
David A Bader ◽  
Jasmina Z Cerne ◽  
Sean E McGuire ◽  
◽  
◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Androgen Deprivation Therapy ◽  
Advanced Prostate Cancer ◽  
Second Generation ◽  
Locally Advanced ◽  
Androgen Deprivation ◽  
External Beam Radiation ◽  
Locally Advanced Prostate Cancer ◽  
Recent Developments

Locally advanced prostate cancer (LAPC) is often managed with a combination of external beam radiation therapy (EBRT) and androgen deprivation therapy (ADT). Clinical protocols combining ADT and EBRT for the treatment of LAPC were developed based on clinical trials that used conventional-dose EBRT (~70 Gy) and luteinizing hormone-releasing hormone (LHRH) analog monotherapy. However, dose-escalated EBRT (>74 Gy) is in widespread clinical use and potent second-generation agents targeting the androgen axis have recently received US Food and Drug Administration (FDA) approval. These and other recent developments challenge the current standard of care for LAPC. Determining the optimal duration and potency of ADT in combination with dose-escalated EBRT in LAPC is an active area of clinical research seeking to balance the side-effect profile of ADT with its well-established therapeutic benefits. Prospective randomized clinical trials incorporating dose-escalated EBRT and second-generation androgen axis inhibitors are necessary to clarify the role of ADT in this new arena. Further, since biochemical response to neoadjuvant ADT predicts for efficacy of EBRT, new trials should seek to achieve maximal androgen suppression prior to EBRT to increase clinical benefit. Last, recent clinical and preclinical research efforts hold significant promise and seek to provide better predictive markers and expand the therapeutic target spectrum in prostate cancer.

Prevention of hip fractures in older men receiving androgen deprivation therapy for prostate cancer: A cost-effectiveness analysis

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6530-6530
Author(s):  
K. Ito ◽  
E. Elkin ◽  
M. Morris
Keyword(s):  
Prostate Cancer ◽  
Cost Effectiveness ◽  
Androgen Deprivation Therapy ◽  
Hip Fractures ◽  
Androgen Deprivation ◽  
Mineral Density ◽  
T Score ◽  
Model Based ◽  
Screening Cost ◽  
The Impact

6530 Background: Androgen deprivation therapy (ADT) increases the risk of osteoporotic fractures. Our goal was to assess the cost-effectiveness of bone mineral density (BMD) screening followed by alendronate therapy at the onset of ADT in men with T2c-T4N0 prostate cancer. Methods: We developed a Markov model of prostate cancer progression and simulated the experience of 70-year-old men with T2c-T4N0 prostate cancer starting a 2-year course of ADT after radiation therapy. We compared four strategies: No BMD screening and no alendronate therapy; BMD screening with alendronate therapy for men with osteoporosis (a T-score ≤ -2.5); BMD screening with alendronate therapy for men with osteoporosis or osteopenia (a T-score ≤ -1.0); and universal alendronate therapy without BMD screening. The main outcome measure was cost per quality-adjusted life year (QALY) gained. Data sources were U.S. epidemiological studies and health care cost figures. A model-based estimate of median survival was 9.5 years. Proportions of men who had a T-score ≤ -2.5 and -1.0 were 10% and 45%, respectively. A model-based incidence of hip fractures with no therapy was 0.93 per 100 person-years. Alendronate reduced the risk of hip fractures by 10%. Results: Compared with no screening and no therapy, BMD screening with alendronate therapy for men with osteopenia or osteoporosis cost $66,100 per QALY gained. BMD screening with alendronate therapy only for those with osteoporosis was slightly more costly and more effective, but had a less favorable ICER. Universal alendronate therapy without screening cost $1,580,300 per QALY gained. These results were most sensitive to assumptions about the impact of alendronate on the rate of BMD loss during ADT and the price of alendronate. Conclusions: In men with T2c-T4N0 prostate cancer, BMD screening with alendronate therapy for men with osteoporosis or osteopenia is a cost-effective use of resources, compared with other medical interventions in oncology. [Table: see text] No significant financial relationships to disclose.

Androgen-deprivation therapy plus docetaxel-based chemotherapy in metastatic hormone-sensitive prostate cancer. A meta-analysis of randomized clinical trials.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 188-188 ◽  
Author(s):  
Allan Ramos-Esquivel ◽  
Joao M. Baptista ◽  
Luis Corrales-Rodriguez ◽  
Ileana Gonzðlez ◽  
Melissa Juarez Villegal ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Androgen Deprivation Therapy ◽  
Metastatic Prostate Cancer ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Androgen Deprivation ◽  
Cochrane Central Register ◽  
Newly Diagnosed ◽  
Hormone Sensitive

188 Background: Androgen-deprivation therapy (ADT) is the standard of treatment for patients with newly diagnosed metastatic prostatic cancer. Nevertheless, recent trials have suggested a role for chemotherapy in these patients. We performed a systematic review and meta-analysis to assess the efficacy and safety of docetaxel-based chemotherapy in combination with ADT for patients with hormone-sensitive metastatic prostate cancer. Methods: Randomized clinical trials (RCT) were identified after systematic searching of electronic databases (MEDLINE, OVID and The Cochrane Central Register of Controlled Trials), as well as ASCO conference proceedings from 2010 to 2015. We included only RCT comparing ADT versus the combination of ADT plus docetaxel-based chemotherapy in patients with newly diagnosed metastatic prostate cancer. A random-effect model was used to determine the pooled hazard ratio (HR) for the efficacy outcomes: overall survival (OS) and clinical progression-free survival (PFS), according to the inverse-variance method. Heterogeneity was measured using the Q and I2statistics. Results: Three RCT (n = 2 262), were included in our meta-analysis (E3805, GETUG-AFU 15 and the M1 subgroup from STAMPEDE Trial). Docetaxel-based chemotherapy plus ADT was associated with improved OS (HR: 0.74; 95% CI: 0.60-0.90; p = 0.003). The heterogeneity of these trials was moderate (Tau2: 0.02; I2: 51%; p = 0.13). Clinical PFS was also significantly better in patients receiving docetaxel-based chemotherapy (HR: 0.67; 95% CI 0.55-0.82; p = 0.0001), with moderate between-study heterogeneity detected (Tau2: 0.01; I2: 42%; p = 0.19). Different subset of patients in these trials can explain the aforementioned heterogeneity. Regarding adverse drug reactions grade 3 or higher, neutropenia was reported in a range from 36% in the GETUG-AFU 15 Trial to 12% in the STAMPEDE trial and febrile neutropenia was reported from 6.1% in the E3805 Trial to 12% in the STAMPEDE Trial. Conclusions: The addition of docetaxel-based chemotherapy to ADT improves OS and clinical PFS. New trials are needed to determine which patients benefit the most from this intervention.

Prevalence of overweight and prediabetes in men receiving systemic therapies for metastatic prostate cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 289-289 ◽  
Author(s):  
Warner Finstad ◽  
Raimundas Galiauskas ◽  
James Cook ◽  
Kate Murphy ◽  
Derbrenn O'Connor ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Androgen Deprivation Therapy ◽  
Steroid Therapy ◽  
Metastatic Prostate Cancer ◽  
American Diabetes Association ◽  
Androgen Deprivation ◽  
Treatment Type ◽  
The Impact ◽  
Systemic Therapies

289 Background: Patients with metastatic prostate cancer receive several therapies which may be associated with a tendency to overweight and impaired glucose tolerance. These include androgen deprivation therapy and long term steroid therapy. We set out to assess the prevalence of overweight and diabetes/prediabetes in a cohort of patients attending an oncology day ward for a variety of systemic therapies. Methods: We performed a retrospective review of the medical records of men attending an oncology day ward for prostate cancer treatment. As part of their usual care, these men had regular height and weight checks and also had periodic hemoglobin A1C (HbA1C) measurements performed. The prevalence of prediabetes and diabetes in this patient population was assessed from the HbA1C results using the American Diabetes Association 2016 definitions. Information on patient steroid use (and type), and treatment type were also recorded. Results: Among 34 men with metastatic prostate cancer, the mean age was 74 (range 57-88). Therapies received included androgen deprivation therapy in all cases, with chemotherapy or novel androgen receptor pathway inhibitors such as abiraterone and enzalutamide. Only 12% had a pre-existing diagnosis of diabetes mellitus (all type 2). The majority (79%) are overweight or obese. 59% have pre-diabetes as per the American Diabetes Association 2016 Guidelines, while a further 24% meet criteria for diabetes. Only 18% have HbA1c in the normal range. 56% are on continuous long term steroid therapy, usually as part of their prostate cancer therapy. A further 23% receive intermittent steroids. Only 21% had received no steroids in the 6 months prior to first HbA1C check. 18% had castrate-sensitive disease and 82% had castrate resistant disease. Even among patients with castrate sensitive disease, 2/3 had abnormal HbA1c values. Conclusions: Overweight and prediabetes are very prevalent in men receiving systemic therapies for metastatic prostate cancer. A large percentage of men are on long-term steroid therapy which may be contributing to their risk of these conditions. Intervention is required for this group of patients to reduce the impact of therapy on cardiovascular and overall health.

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