Prostate cancer clinical trials consortium: A multicenter mechanism for the rapid design, development, and implementation of early phase clinical trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16065-e16065
Author(s):  
J. Vinson ◽  
P. Mathew ◽  
T. M. Beer ◽  
M. A. Carducci ◽  
W. Oh ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Data Storage ◽  
Early Phase ◽  
Phase 1 ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Research Centers ◽  
Design Development ◽  
Multicenter Studies

e16065 Background: Leading investigators in prostate cancer have hypothesized that clinical trials (CT) are optimally conducted as multicenter studies. To test this, the Prostate Cancer Clinical Trials Consortium (PCCTC) was formed with support from the Prostate Cancer Foundation (PCF) and the Department of Defense Clinical Consortium Award (DOD). Since the PCCTC's inception in 2006, members have cooperatively designed, carried out, and evaluated phase 1 and 2 multicenter studies in prostate cancer. Methods: PCF and DOD awards support a consortium of 13 cancer research centers. Memorial Sloan-Kettering Cancer Center serves as the coordinating center and is charged with creating an infrastructure to conduct early phase, multicenter trials. Annually, each participating center is required to introduce at least one CT for consideration by the PCCTC and accrue at least 35 patients to PCCTC studies. Investigators meet face-to-face twice per year to discuss the PCCTC's progress, and hold monthly conference calls to discuss scientific objectives, trial design, and ongoing studies. Results: Since inception, the PCCTC has expanded from 8 to 13 leading research centers. Through September 2008, it has opened 47 trials and accrued 1,282 patients at member sites. Members utilize a CT management system for protocol tracking, electronic data capture, and data storage. A legal framework has been instituted, and standard operating procedures, administrative structure, editorial support, centralized budgeting, and mechanisms for scientific review have been established. Each year, the number of trials presented and patients accrued increases, and three concepts have progressed to the next phase of clinical testing. Conclusions: The PCCTC fulfills a congressional directive to create a CT instrument dedicated to rapid accrual to early-phase, multicenter studies in prostate cancer. The member institutions have built a shared administrative, informatics, legal, financial, statistical, and scientific infrastructure to support this endeavor. As the PCCTC has expanded and taken an increasingly active role in designing and evaluating protocols, clinical trials continue to open and accrue in excess of federally mandated goals. No significant financial relationships to disclose.

scholarly journals Barriers to Enrollment of Elderly Adults in Early-Phase Cancer Clinical Trials

2008 ◽  
Vol 4 (4) ◽  
pp. 162-168 ◽  
Author(s):  
Michele Basche ◽  
Anna E. Barón ◽  
S. Gail Eckhardt ◽  
Lodovico Balducci ◽  
Martha Persky ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Early Phase ◽  
Age Groups ◽  
Experimental Treatment ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Sources Of Information ◽  
Barriers To Participation ◽  
University Center ◽  
Barriers To Enrollment

Purpose: To describe patient/family and logistical barriers to participation in university-based, early-phase cancer clinical trials for adults age ≥ 65 years, and to identify influences on their decisions to participate. Participants and Methods: In-person surveys were administered to subjects age ≥ 65 years with advanced tumors who had received prior chemotherapy. Subjects were recruited from private medical oncology practices collaborating with the University of Colorado and Moffitt Cancer Center research networks. Results: Three hundred individuals (51% age 65 to 74 and 49% age 75 or older) responded. Overall, 60% reported one or more barriers to participation in an early-phase trial; logistical barriers such as driving or time demands (34%) or reluctance to be treated at a university center (21%) were most common. Seniors age 75 or older were more reluctant to be treated at a university center (27% v 14%; P = .005), or concerned about loss of continuity with their primary oncologist (24% v 15%, P = .05). Older seniors were also significantly more reluctant than younger seniors to consider treatments with substantial nausea, vomiting, or fatigue. Older and younger seniors differed little in their preferred sources of information; both age groups emphasized the importance of the primary oncologist (100%), a nurse who provides experimental treatment (93%), other patients (83%) or acquaintances who had received experimental treatment (83%). Conclusion: Potential strategies to overcome barriers to enrollment of seniors into early-phase trials include providing more information about trials to community oncologists and prospective enrollees and assisting these individuals in navigating logistical barriers to enrollment.

Perceptions about cancer clinical trials among prostate cancer survivors.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 42-42
Author(s):  
Joanne S. Buzaglo ◽  
Melissa F Miller ◽  
Shauna McManus ◽  
Jamese Johnson ◽  
Alexandra Katherine Zaleta
Keyword(s):  
Prostate Cancer ◽  
Health Care ◽  
Clinical Trials ◽  
Treatment Decision ◽  
Health Care Team ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
Random Assignment ◽  
Prostate Cancer Survivors ◽  
Strongly Agree

42 Background: Recruitment into cancer clinical trials (CCTs) remains challenging despite efforts to enhance patient understanding of and access to CCTs. We examined perceptions of CCTs among prostate cancer (PC) survivors. Methods: 86 PC survivors enrolled in Cancer Support Community’s Cancer Experience Registry online research platform, provided demographic and disease history, and rated their agreement (0 = strongly disagree; 4 = strongly agree) with 8 CCT statements. We examined bivariate associations between CCT counseling and individual factors via Spearman’s rank correlation and chi-square tests. Results: Participants were 95% White; mean (SD) age = 65 (7) years; time since diagnosis 4 (4) years. 24% had surgery, 34% underwent radiation, 20% both; 31% currently and 18% previously received hormone therapy. 32% were diagnosed 5+ years ago; 22% reported recurrence, 31% metastatic disease. 33% reported that their health care team spoke to them about participating in a CCT, with a non-significant trend for lower prevalence if all or part of care was received at a community hospital/cancer center (24%) vs. at an academic or comprehensive cancer center or private oncology practice (47%; χ2= 3.03, p = .082). 25% did not receive information about CCTs from the health care team prior to making a treatment decision. 21% reported there was a CCT available to them; 35% considered a CCT for treatment; 11% participated in a CCT. Regarding beliefs about CCTs (% agree or strongly agree): 64% felt uncomfortable with treatment random assignment; 52% feared receiving a placebo; 40% feared treatment side effects; 23% believed health insurance would not cover a CCT; 16% believed no clinical trials are available in their community; 16% felt mistrust and fear of being used as a “guinea pig” for research; 11% had concern about logistical barriers, e.g., transportation; 6% did not understand what CCTs are. Conclusions: Many prostate cancer survivors are uncomfortable with random assignment to treatment in a CCT and fear receiving a potentially ineffective placebo. Our findings underscore the need for comprehensive treatment decision counseling and patient education via health care providers and patient advocacy organizations.

Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18501-e18501
Author(s):  
Ryan Huu-Tuan Nguyen ◽  
Yomaira Silva ◽  
Vijayakrishna K. Gadi
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trials ◽  
Drug Approval ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cancer Prevalence ◽  
Fda Approval ◽  
The Us ◽  
Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

Beyond the Development of Health-Related Quality-of-Life (HRQOL) Measures: A Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials—Does HRQOL Evaluation in Prostate Cancer Research Inform Clinical Decision Making?

2003 ◽  
Vol 21 (18) ◽  
pp. 3502-3511 ◽  
Author(s):  
Fabio Efficace ◽  
Andrew Bottomley ◽  
David Osoba ◽  
Carolyn Gotay ◽  
Henning Flechtner ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Decision Making ◽  
Clinical Trials ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Cancer Clinical Trials ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related

Purpose: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer. Materials and Methods: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making. Results: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions. Conclusion: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.

Racial disparities in access to prostate cancer clinical trials: A county-level analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6553-6553
Author(s):  
Aasthaa Bansal ◽  
Wei-Jhih Wang ◽  
Caroline Savage Bennette ◽  
Scott David Ramsey
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
Cancer Treatment ◽  
Cancer Clinical Trials ◽  
County Level ◽  
Prostate Cancer Treatment ◽  
Cancer Trial ◽  
Treatment Trials ◽  
Per Capita ◽  
The Relationship

6553 Background: African American men (AAs) have a higher burden of prostate cancer compared to other populations. We sought to determine if they experience disparities in access to prostate cancer clinical trials. Methods: We created a county-level database of all U.S. counties by linking together prostate cancer clinical trial data from the Aggregate Analysis of ClincalTrials.gov (AACT) database with county-level socioeconomic, demographic and healthcare facility data derived from several external data sources. Using this data linkage, we examined two specific potential access barriers. First, we investigated the relationship between %AAs in the county and access to NCI designated cancer facilities, adjusting for county population size and other characteristics. Then, among counties with cancer facilities, we investigated the relationship between the %AAs in the county and number of available prostate cancer treatment trials per capita per year. We used logistic and negative binomial regression models, respectively, to address these questions. Results: Between 2008 and 2015, 613 prostate cancer trial sites were found among 3,145 U.S. counties. Counties with higher %AAs were less likely to have cancer facilities (adjusted odds ratio = 0.85, 95% CI (0.78, 0.92)). Among counties with cancer facilities, those with higher %AAs had significantly fewer prostate cancer trials per capita per year (rate ratio per 10% increase in %AAs: 0.90, 95% CI (0.83,0.96)), after adjusting for county-level sociodemographic and healthcare system factors. Conclusions: Counties with higher proportions of AAs appear to be less likely to have access to NCI designated cancer facilities. Among counties with cancer facilities, those with higher proportions of AAs appear to have fewer available prostate cancer treatment trials per capita per year. Clinical trials in prostate cancer therapy should ensure adequate availability of enrollment sites in regions with high concentrations of AAs.

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