healthy men involved in the prevention of the Trial prostate cancer are more likely to undergo a biopsy

healthy men involved in the prevention of the Trial prostate cancer are more likely to undergo a biopsy -

healthy men involved in prevention trial for prostate cancer who are actively involved in all phases of the clinical trial are more likely to have a biopsy, according to a study published in cancer Epidemiology, Biomarkers and prevention -. a journal of the American Association for Cancer Research

The Prevention Trial prostate cancer was a randomized, double-blind against placebo that tested the effectiveness of finasteride, a drug used for the prevention of Prostate cancer. This study was conducted by SWOG -. A cooperative group cancer research that designs and produces multidisciplinary clinical trials

Researchers at the University of Texas MD Anderson Cancer Center and Research Center Fred Hutchinson Cancer used a systematic model for identify factors associated with men adhering to the requirement of end of study (EOS) trial biopsy. EOS biopsy, an invasive procedure that examines cells or prostate gland tissue to determine if the cancer is obvious, is an important part of the study.

"Our study is unique in that it evaluated the factors prospectively associated with an invasive biopsy for a cancer prevention trial, not a cancer treatment trial," said Ellen R. Gritz, Ph.D. .D., chairman of Behavioral science at MD Anderson and lead author of the study.

preventing the trial was coordinated by 219 SWOG sites with more than 18,000 men. The participants were randomly divided into two groups; those given finasteride and those given a placebo. Participants received educational materials on the procedures of study and biopsy and were invited to attend regular appointments throughout the trial.

Funded by the National Cancer Institute, the scientists analyzed the healthy men over a period of seven years to identify factors in the six-year mark study were associated with the will of the participant to undergo a biopsy. The factors examined included psychosocial outcomes, the participants' state of health, participating membership, and the characteristics of clinical sites in which the study was conducted.

"The biopsy provided the biological samples that could be tested to see if the prostate of a man cells were cancer-free after seven years on the trial," said Carol Moinpour, Ph.D. , cancer Research Center Fred Hutchinson. "in other words, the biopsy has provided definitive information on which the men had prostate cancer seven years after the study began."

the researchers were assess the factors associated with membership of more than 13,000 test men and analyzed the factors on the basis of whether or not the study participants were invited to a clinical biopsy of the year six study.

researchers found participants were more likely to join the EOS biopsy if a year before the biopsy, they were adhering to the study drug, kept appointments and . undergone necessary tests and were healthy participants who had an EOS biopsy were more likely to be adherent to study medication in the sixth year - 84 percent. Participants who are not biopsied, only 47 percent were adherent to study medication. The results also showed that 98 percent of men who had a biopsy EOS had the DRE (digital rectal exam) or PSA test done in the sixth year, compared to 75 percent of men who do not have the EOS biopsy.

"We also found that participants were more likely to join biopsies if the study site that recruited the participant registered more than 0 participants and / or resources had to carry out activities to encourage continued participation in the trial, "said Gritz.

researchers reported behavior monitoring adherence in clinical trial participants can help identify participants at risk of non-compliance with a requirement of the study, and help create a model for accession intervention strategies in future trials.

"If we are able to determine what factors are associated with good adherence to study regimens evaluate cancer prevention agents, we may be able to improve the conduct of these large trials targeting interventions to stimulate membership, "said Gritz.