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.

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.

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Disclosure ND reports a consulting role in Vivreon Gastroscience Inc. SL reports consulting roles in Exelixis, Merck, SeaGen, Easai, and EMD Serono. AT reports research funding from Clovis Oncology, Corvus Pharmaceuticals, EMD Serono, Aravive Inc, WindMIL Therapeutics, Bayer; honoraria from Urology times, Cardinal Health, Targeted Oncology; consulting roles Foundation Medicine, Pfizer, Genzyme, EMD Serono, Exelixis, Deka Biosciences, Seattle Genetics, Aadi biosciences, and Seattle Genetics/Astella. TD reports researching funding from Pfizer as well as consulting roles in Bayer, Janssen Oncology, Seattle Genetics, Abbvie, Exelixis, Advanced Accelerator Applications, and Astra Zeneca. SKP reports consulting roles in Genentech, Aveo, Eisai, Roche, Pfizer, Novartis, Exelixis, Ipsen, BMS, Astellas. HE, DC, MF, SP, KL, EC, TP, IS, JP, XL, ZZ, LM, BM, JH, AG, NC, CB, AR, and ACR declare no conflicts of interest