Examining Exclusion Criteria in Advanced Prostate Cancer Clinical Trials: An Assessment of recommendations From the American Society Of Clinical Oncology and Friends of Cancer Research

• Published in: Clinical genitourinary cancer 2023-12, Vol.21 (6), p.e467-e473
• Main Authors: Ebrahimi, Hedyeh, Castro, Daniela V., Feng, Matthew I., Prajapati, Sweta R., Lee, Kyle O., Chan, Elyse H., Paul, Trishita, Sehgal, Ishaan, Patel, Jalen, Li, Xiaochan, Zengin, Zeynep B., Meza, Luis, Mercier, Benjamin D., Hsu, JoAnn, Govindarajan, Ameish, Chawla, Neal, Dizman, Nazli, Bergerot, Cristiane D., Rock, Adam, Liu, Sandy, Tripathi, Abhishek, Dorff, Tanya, Pal, Sumanta K., Chehrazi-Raffle, Alexander
• Format: Article
• Language: English
• Subjects: Brain Neoplasms; Clinical trial; Eligibility determination; Friends; Hepatitis C; HIV Infections - drug therapy; Humans; Male; Medical Oncology; Prostatic neoplasms; Prostatic Neoplasms - therapy; Research Design; Urologic Neoplasms
• ISSN: 1558-7673; 1938-0682
• DOI: 10.1016/j.clgc.2023.05.013

Eligibility criteria illustrate the characteristics of the study population and promote the safety of participants. However, overreliance on restrictive eligibility criteria may limit the generalizability of outcomes. As a result, the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) issued statements to curtail these challenges. In this study, we aimed to assess restrictiveness in eligibility criteria across advanced prostate cancer clinical trials. We identified all phase I, II, and III advanced prostate cancer clinical trials between June 30, 2012, and June 30, 2022, through Clinicaltrials.gov. We evaluated whether a clinical trial excluded, conditionally included, or did not report 4 common criteria: brain metastases, prior or concurrent malignancies, HIV infection, and hepatitis B virus (HBV)/hepatitis C virus (HCV) infection. Performance status (PS) criteria were recorded based on the Eastern Cooperative Oncology Group (ECOG) scale. Out of 699 clinical trials within our search strategy, 265 (37.9%) trials possessed all the required data and were included in our analysis. The most common excluded condition of our interest was brain metastases (60.8%), followed by HIV positivity (46.4%), HBV/HCV positivity (46.0%), and concurrent malignancies (15.5%). Additionally, 50.9% of clinical trials only included patients with ECOG PS 0 to 1. HIV and HBV/HCV infection were exclusion criteria of 22 (80.8%) and 19 (73.1%) immunotherapy trials, respectively. Patients with brain metastases, prior or concurrent malignancies, HIV infection, HBV/HCV infection, or low-functioning PS were overly restricted from participating in advanced prostate clinical trials. Advocating for broader criteria may ameliorate generalizability. A comprehensive evaluation of advanced prostate cancer clinical trials' eligibility criteria between 2012 and 2022 demonstrated an overly restrictive eligibility criteria among patients with concurrent brain metastases, prior or concurrent malignancies, HIV infection, HBV/HCV infection, and performance status. More inclusive eligibility criteria are required to enhance generalizability of the clinical trials.