Knowledge and attitudes regarding clinical trials and willingness to participate among prostate cancer patients

5169 Background: A large proportion of prostate cancer patients receive their care within the VA Healthcare System. As this is a population affected by complex comorbidities, they may be underrepresented in oncology clinical trials. Our objective was to quantify the frequency with which castrate resistant prostate cancer (CRPC) patients in VACHS would be excluded from major phase III randomized controlled trials. Methods: We reviewed records of all prostate cancer patients at the VACHS between 2004–2007 and identified patients with CRPC. We reviewed eligibility criteria of 24 major phase III clinical trials, from 2006 onwards, studying investigational drugs for CRPC and created a “master list” (ML) of the most pertinent criteria. We analyzed our patient population according to both the ML criteria and to the TAX327 study criteria. Results: We identified 106 patients with CRPC, excluded 7 patients with insufficient medical records, and analyzed 99 patients. Performance status and life expectancy could not be accurately assessed from most charts and were excluded as specific criteria (though reflected in other serious medical condition). Major reasons for exclusion according to ML/TAX327 criteria include: 10/10 other malignancy within 5 years; 11/14 abnormal laboratory parameters; 27/30 other serious medical conditions; 3/4 abnormal cardiac function. ML list only exclusions: 5 active angina; 1 unstable DM; 1 major GI surgery; 1 contraindication to steroids. Serious medical conditions included: active cardiac disease, dementia, serious neurologic, psychiatric, vascular, pulmonary or hematologic disease, and poor performance status or compliance. Overall, 45% (45/99) of patients were excluded when using both the ML and TAX327 criteria. Conclusions: Approximately half of CRPC patients in the VACHS between 2004–2007 did not meet eligibility criteria for major therapeutic trials for CRPC. This retrospective review demonstrates that VA patients are underrepresented in randomized clinical trials for CRPC and are a special population due to their complex comorbidities. These findings underscore the importance of designing better clinical trials for CRPC with less barriers for this underrepresented but common patient population. No significant financial relationships to disclose.

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Perceptions and barriers towards clinical trials participation in Asian cancer patients.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e19523 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e19523-e19523

Author(s):

I Peng Thomas Soh ◽

Cheong Kiat Julian Tay ◽

Gui Yi Ho ◽

Angela Pang ◽

Pei Jye Voon ◽

...

Keyword(s):

Clinical Trials ◽

Cancer Patients ◽

Willingness To Participate ◽

Asian Patients ◽

Perceptions And Attitudes ◽

Information Awareness ◽

National University ◽

Successful Execution ◽

Refusal To Participate ◽

The Cost

e19523 Background: There is currently limited data on the perceptions and attitudes of Asian cancer patients towards therapeutic clinical trials (CTs). Understanding this is crucial to their successful execution. Methods: From May to December 2011, we surveyed cancer outpatients at the National University Cancer Institute, Singapore, and collected data on patient demographics, tumor information, awareness, perceptions, and willingness to participate in CTs. Results: 240 patients were surveyed, including 85 (35%) who had previously participated, 141 (59%) who had never participated, and 14 (6%) who had refused participation in a CT. The majority was Chinese (78.8%) or Malay (16.7%), 57.5% was female and median age was 56 years (range 22-83). There were no differences in demographics between patients who had, had not or refused participation in a CT. 135 patients (56%) had prior awareness of CTs, and were more likely to be female (p=0.027) or had metastatic disease (p=0.002). 111 (46%) patients were willing to participate in CTs given the opportunity, and were more likely to have prior awareness of CTs (76.6% vs 38.8%, p<0.001), to believe that CT sponsorship covers only the cost of trial drugs (52.3% vs 24%, p<0.001), and to state that paying for non-trial related or standard expenses was reasonable (35.1% vs 19.4%, p=0.006), compared to patients who were not willing to participate. Patient age, gender, education, income, or availability of health insurance did not influence willingness to participate. The majority of patients who had participated in CTs (66/85, 78%) reported only positive experiences, while 13 (15%) reported mixed experiences, and only 2 (2.4%) reported only negative experiences. The feeling of being treated as ‘guinea pigs’ (n=7), and fear of toxicities (n=5) were the main reasons cited for refusal to participate in CTs. Conclusions: Asian patients have moderate awareness of CTs, and slightly less than half the patients surveyed were willing to participate in CTs. Prior knowledge of CTs was associated with increased willingness to participate, and improving awareness through education could facilitate enrollment.

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Resveratrol and prostate cancer: the power of phytochemicals

Current Medicinal Chemistry ◽

10.2174/0929867328666201228124038 ◽

2020 ◽

Vol 28 ◽

Author(s):

Nadia Zaffaroni ◽

Giovanni L. Beretta

Keyword(s):

Prostate Cancer ◽

Clinical Trials ◽

Antitumor Activity ◽

Cancer Patients ◽

Drug Combination ◽

Natural Compound ◽

Latency Period ◽

Chemopreventive Agent ◽

Long Latency ◽

Combination Studies

: Prostate cancer is the fifth cause of tumor-related deaths in man worldwide. Due to its long latency period, this pathology represents an ideal type of disease for chemopreventive studies. Among the drugs considered thus far for the treatment of prostate cancer, the natural compound resveratrol emerged as very promising. Resveratrol is a widely recognized as chemopreventive agent and was shown to potentiate the antitumor activity of conventional chemotherapeutics in several tumors, including prostate cancer. Here we overview the literature of the last five years and summarize the recent achievements of resveratrol and its derivatives as antimetastatic agents in prostate cancer. Moreover, drug combination studies as well as nanomedicine approaches proposed to improve resveratrol activity and to overcome delivery drawbacks are addressed. The last part of the review discusses the clinical trials containing resveratrol ongoing on cancer patients.

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Health status in senior adult prostate cancer patients: Limits for active treatment and clinical trials inclusion

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.15550 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 15550-15550

Author(s):

J. Droz ◽

G. Albrand ◽

A. Chaladaj ◽

A. Fléchon ◽

C. Terret

Keyword(s):

Prostate Cancer ◽

At Risk ◽

Clinical Trials ◽

Health Status ◽

Cancer Patients ◽

Geriatric Oncology ◽

Good Health ◽

Median Number ◽

Functional Domain ◽

Careful Clinical Examination

15550 Background: Two-third of patients (pts) with prostate cancer are older than 70 years. Patients are likely to receive active treatments in the curative and palliative settings if they have good health status, moreover they are likely to be offered to participate to clinical trials. Health status evaluation is performed by Comprehensive Geriatric Assessement (CGA). Methods: We have prospectively performed a mini- CGA (Terret C, Expert Rev Anticancer Ther. 2004; 4 : 469–75.) in 69 patients with prostate cancer : 33% pts had localized disease, median age was 78.7 years (68–92). Mini-CGA was based on a careful clinical examination with analysis of physical function, nutritional status (MNA), functional domain (ADL, IADL), cognitive and emotional domains (MMSE, GDS), identification and grading of comorbid conditions (CIRS-G), and a medication review. Social and familial evaluations complete the procedure. Results: Dependancy: only 12% pts are fully independant for ADL and 11% for IADL; 20% pts experienced falls and 32% were at risk of fall. Cognitive functions and depression: 60% pts had normal cognitive funtions, 46% and 4% were moderately and deeply depressed respectively. Nutrition: 22% pts had severe weight loss, 23% were mal nourished and 41% at risk of denutrition. Comorbidities: median CISR-G score was 8 (3–12), 80% and 21% pts had at least one grade 3 and one grade 4 comorbidity respectively. The most frequent comorbidities were by decreasing order of incidence : psychologic, hematologic, endocrine and osteo-articular pathologies. Polymedication: median number of drugs taken by pts was 5 (0–14) and iatrogenicity was observed in 30% pts. A caregiver was identified in 83% pts and 16% pts were living alone. None of the pts were fully independant with no major comorbidity. Conclusions: Health status of prostate cancer patients older than 70 years must be evaluated with the objective to either tailor specific clinical trials or apply adapted standard treatments. Task forces of the International Society of Geriatric Oncology (SIOG) are on the process to establish specific guidelines for prostate cancer treatment in the senior adults and for selection of manageable CGA procedures. [Table: see text]

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Perception and knowledge of clinical trials and factors affecting participation of regional and rural cancer patients of North Queensland

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e17558 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e17558-e17558

Author(s):

S. S. Sabesan ◽

B. Burgher ◽

S. Varma ◽

P. Piliouras

Keyword(s):

Clinical Trials ◽

Phase I ◽

Cancer Patients ◽

Phase 1 ◽

Willingness To Participate ◽

Or Education ◽

Factors Affecting ◽

Significant Relationships ◽

Rural Patients ◽

Phase I And Ii

e17558 Background: The best treatment option for most cancers is participation in clinical trials. Participation in trials is generally low and among rural patients it is likely to be even lower. The aim of this study was to assess knowledge about and attitudes towards clinical trials among rural and regional cancer patients of North Queensland. Methods: A questionnaire-based survey was conducted in outpatient clinics at the Townsville Cancer Centre on all types of cancer patients. Results: The mean age of the 178 participants was 56 years and 45.4% lived in rural or remote areas. Median distance to the trial centre (Townsville) for rural participants was 180 km (range 80 - 1300 km). Being asked whether they would take part in a RCT, 13.2% of participants said no, 56.3% said yes, and 30.5% were unsure. There were no significant relationships between willingness to participate and rurality (p = 0.896) or education level (p = 0.943). For the majority of patients, the number of clinic visits and blood tests required did not matter. Cost of travel (41.1% rural/remote; 23.5% regional; p < 0.001) and the need for family or friends to accompany (38.9% rural/remote; 24.1% regional; p = 0.021) were more important for rural/remote than regional patients as factors affecting participation. Only 16.4% of participants were aware of early studies. After education, percentage of patients willing to participate in phase I and II studies were 57% and 84%, respectively. Rural patients were less willing to participate in phase I studies than regional patients (33.9% vs 52.6%, p = 0.029). Conclusions: Rural patients are as interested in participating in clinical trials as urban patients except for phase 1 trials and should not be excluded because of rurality. Knowledge of trials is poor and there is a need for education early. Cost of travel seems more important for rural patients and as such budgets should include cost of travel to encourage participation of rural patients. No significant financial relationships to disclose.

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