This article is more than 5 years old. Information may no longer be current.
Prostate cancer prevention trial identified behaviors linked to biopsy adherence
Among participants in the Prostate Cancer Prevention Trial, those who complied with study requirements 1 year before the end of the study were more likely to complete the end-of-study biopsy.
“Our study is unique because it evaluated factors prospectively associated with an invasive biopsy for a cancer prevention trial, not a cancer treatment trial,” researcher Ellen R. Gritz, PhD, chair of Behavioral Science at The University of Texas MD Anderson Cancer Center, said in a press release.
Ellen R. Gritz
Based on data from the Prostate Cancer Prevention Trial — a 7-year randomized, double blind, placebo-controlled study conducted at 219 sites, evaluating the effectiveness of finasteride in preventing prostate cancer in healthy men — Gritz and colleagues sought to identify trial participants who would be most likely to adhere to the end-of-study biopsy.
Participants were randomly assigned to a regimen of finasteride or placebo, with a primary endpoint of 7-year prevalence of prostate cancer. Participants were provided with educational literature about the study and biopsies, and were asked to comply with scheduled appointments throughout the study.
Researchers utilized a logistic regression-based systematic modeling process to determine the factors identified in year 6 that were correlated with end-of-study biopsy at year 7, stratified by biopsy prompt history. The researchers identified 13,590 men who were eligible for inclusion in the study at year 6. Among the covariates analyzed were psychosocial outcomes, health status of the participants and characteristics of the particular study site.
Gritz and colleagues found that patients who complied with the end-of-study biopsy were more likely to be adherent to the study drug at year 6 than those who did not complete the biopsy (84.2% vs. 46.9%) or have complied with a digital rectal exam or PSA test at year 6 (98.5 vs. 75.2%). Additionally, patients at larger study sites or at locations that had been awarded retention/adherence grants were more likely to comply with end-of-study biopsy (
“If we are able to determine which factors are associated with good adherence to study regimens evaluating cancer prevention agents, we may be able to improve the conduct of such large trials by targeting interventions to boost adherence,” Gritz said in the release.
Disclosure: Researchers reported stock ownership in Merck.