SW—OG, a National Cancer Institute supported organization that conducts clinical trials in adult cancers, recently completed a study called the Prostate Cancer Prevention Trial, which revealed that healthy male participants that went through all the necessary steps of the trial have a higher likelihood of undergoing a preventive biopsy. This study, entitled “Factors Associated with Adherence to an End-of-Study Biopsy: Lessons from the Prostate Cancer Prevention Trial,” is currently available in the Cancer Epidemiology, Biomarkers and Prevention journal of the American Association for Cancer Research.
The trial was designed to determine the effectiveness of finasteride, a drug normally prescribed to prevent prostate cancer. A group of investigators from The University of Texas MD Anderson Cancer Center and the Fred Hutchinson Cancer Research Center sought to profile the factors that encourage men to better comply with the trial’s end-of-study (EOS) prerequisite.
Ellen Gritz, Ph.D., the study’s lead investigator, and chair of Behavioral Science at MD Anderson, said that the experiment is the first of its kind because it seeks to identify factors that are linked to undergoing a biopsy for the sake of cancer prevention, as opposed to going through the procedure for actual treatment.
The study enrolled 18,000 male participants, randomly designated into two groups — one given finasteride, and the other given a placebo. The participants were then provided with information on the procedures of getting a biopsy, and were encouraged to come to prescheduled appointments.
|Ellen R. Gritz, Ph.D.|
The study lasted seven years, which allowed ample time for the researchers to determine what factors contributed to the participants’ readiness to have a biopsy performed. Some of the factors they took note of were psychosocial outcomes, participant health status, participant adherence, and characteristics of the clinical sites at which the study was conducted.
The study’s findings revealed that the participants were more inclined to undergo the EOS biopsy if one year before the procedure they were compliant with finasteride, attended the scheduled appointments, and consented to several mandatory tests. Those who had the biopsy had a higher likelihood of drug compliance by the 6th year (86%), while only 47% those who did not get the biopsy adhered to the drug. 98% of the participants who underwent a biopsy consented to a digital rectal exam or a PSA test during the 6th year, compared to the 75% of those who were not biopsied.
The investigation concluded that it is necessary to study the behavior of participants during a study along with what factors can predict it with regard to prevention and treatment compliance. These findings may be useful in future structured interventions that encourage adherence to disease management.