Abstract
Mermelstein and colleagues conducted a mixed-methods study examining Black men’s knowledge, attitudes, and beliefs about prostate cancer and their sources of health information, aiming to inform educational interventions (Mermelstein et al., 2025). While education is certainly needed, the more urgent audience may be screening advocates within the medical community, whose assumptions about the benefits of screening have been widely, and in my view, mistakenly accepted.
As Dr. Lucassen has argued, many prostate cancer screening studies lack appropriate control groups and fail to use overall survival (OS) as the primary endpoint (Lucassen et al., 2025). Such studies may demonstrate feasibility but cannot establish clinical benefit. These points are basic and well-established in textbooks. It is surprising that such fundamental issues have been overlooked within the medical community involved in prostate cancer screening. This oversight stems from the fact that the natural course of OS in screen-detected prostate cancer has not been shown to be worse than that of otherwise healthy individuals (Takahashi, 2024), making it difficult to design “scientifically sound” trials in practice.
As a result, much of the literature consists of case series and feasibility or pilot studies—designs that rank low in the evidence hierarchy and should not be regarded as definitive. The most rigorous studies are three randomized controlled trials—The Prostate, Lung, Colorectal and Ovarian (PLCO), The European Randomized Study of Screening for Prostate Cancer (ERSPC), and Cluster randomised triAl of PSA testing for Prostate cancer (CAP)—which, despite differences in design and methodology, consistently show no improvement in OS (Grossman et al., 2018). This constitutes Level 1 evidence. Proponents of screening, including many urologists, often cite the ERSPC’s reduction in prostate cancer-specific mortality as evidence of benefit (Mermelstein et al., 2025; Pinsky & Parnes, 2023). However, cancer-specific mortality is a problematic endpoint (Penston, 2011): Cancer-specific mortality is a common data point in registry and epidemiological studies; however, it is based on the subjective judgment of the physician who certifies the cause of death. In clinical trials, it is essential to accurately identify the cause of death and define cancer-specific mortality within that context. However, in practice, this is often not feasible. In younger populations with few competing risks, OS may approximate cancer-specific survival; however, this approximation fails in older adults. An endpoint that is difficult to ascertain reliably cannot be used as the foundation of evidence.
Although Black men experience higher prostate cancer mortality, screen-detected cancers are not the same as the clinically lethal cancers that lead to death (Takahashi, 2024). Current evidence indicates that screening does not reduce mortality or extend lifespan (Bretthauer et al., 2023; Grossman et al., 2018).
Offering an intervention without demonstrated benefit to otherwise healthy people should be regarded as human subjects research. If prostate cancer screening is to be promoted—whether for Black men or any other group—it must adhere to the Helsinki Declaration: provide clear, advance information about the unproven benefits, incorporate appropriate control groups, and designate OS as the primary endpoint. Without these measures, we will continue to accumulate data of limited scientific value. Furthermore, the costs of such trials should be borne by the investigators, not by participants or publicly funded insurance programs.
Mermelstein et al. suggest that Black individuals, along with other participants in screening studies, seek trustworthy communities and health care providers (Mermelstein et al., 2025). The trust of Black individuals, as well as of the general healthy population undergoing prostate cancer screening, can only be earned through a rigorous commitment to medical ethics and scientific integrity.
Footnotes
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