Should This Prostate Drug Be Used For Cancer Prevention?
Should the Proscar pill and various generic versions be used to prevent prostate cancer? This question will likely be debated extensively thanks to a new study clarifying decade-old concerns that the drug, known as finasteride, may boost the risk of developing aggressive, high-grade tumors. The issue was first raised in a 2003 study that found the drug lowered the risk of developing prostate cancer by 30 percent.
As a result of that earlier study, the FDA never approved finasteride for preventing prostate cancer and, instead, required warnings on the product labeling to thwart an unapproved use. (The drug is approved to shrink enlarged prostates and male pattern baldness). Now, though, a follow-up study finds that survival rates were the same in men taking the drug and those who were given a placebo.
The follow-up study, which was published in The New England Journal of Medicine, was undertaken to determine whether the drug could lower the risk of prostate cancer in men who were screened with annual PSA (prostate specific antigen) tests. The researchers tracked nearly 19,000 men for almost 18 years since they enrolled in the earlier trial and Social Security death records were reviewed.
The data “showed that the use of finasteride over a period of seven years in a general population of men with a median age at study entry of 63.2 years reduced the risk of prostate cancer, but did not significantly affect mortality,” the researchers wrote. “…The 15-year rate of survival in each of the two groups was approximately 78 percent" (here is the abstract).
The findings are also likely to fine tune views about PSA testing. Last year, you may recall, the US Preventive Services Task Force, an independent panel, issued a controversial recommendation against routine PSA screening over concerns that overdiagnosis and overtreatment was occurring, while few lives were being saved.
In the study, men who were taking finasteride were 43 percent less likely to be diagnosed with low-grade prostate cancer, which is the type most likely to lead to unnecessary treatment. And so, the findings suggest that the drug may be a viable option for men who choose to be screened; the authors estimated the drug could save about 70,000 men a year from the vagaries of diagnosis and treatment.
The drug “decreases the harm of the PSA,” Otis Brawley, chief medical officer at the American Cancer Society, who helped design the earlier study, tells USA Today. “It helps assure that the men who get diagnosed actually need treatment.” He adds that men who are not screened have no reason to take the drug, because those not getting screened are unlikely to be unnecessarily diagnosed or treated.
In an accompanying editorial, Michael LeFevre, a family physician at the University of Missouri who sat on the task force, wrote that “men who are aware of and understand the benefits, risks and uncertainties associated with (the drug) for prevention may make a rational decision to take the drug to reduce the harm of screening.”
As a result of that earlier study, the FDA never approved finasteride for preventing prostate cancer and, instead, required warnings on the product labeling to thwart an unapproved use. (The drug is approved to shrink enlarged prostates and male pattern baldness). Now, though, a follow-up study finds that survival rates were the same in men taking the drug and those who were given a placebo.
The follow-up study, which was published in The New England Journal of Medicine, was undertaken to determine whether the drug could lower the risk of prostate cancer in men who were screened with annual PSA (prostate specific antigen) tests. The researchers tracked nearly 19,000 men for almost 18 years since they enrolled in the earlier trial and Social Security death records were reviewed.
The data “showed that the use of finasteride over a period of seven years in a general population of men with a median age at study entry of 63.2 years reduced the risk of prostate cancer, but did not significantly affect mortality,” the researchers wrote. “…The 15-year rate of survival in each of the two groups was approximately 78 percent" (here is the abstract).
The findings are also likely to fine tune views about PSA testing. Last year, you may recall, the US Preventive Services Task Force, an independent panel, issued a controversial recommendation against routine PSA screening over concerns that overdiagnosis and overtreatment was occurring, while few lives were being saved.
In the study, men who were taking finasteride were 43 percent less likely to be diagnosed with low-grade prostate cancer, which is the type most likely to lead to unnecessary treatment. And so, the findings suggest that the drug may be a viable option for men who choose to be screened; the authors estimated the drug could save about 70,000 men a year from the vagaries of diagnosis and treatment.
The drug “decreases the harm of the PSA,” Otis Brawley, chief medical officer at the American Cancer Society, who helped design the earlier study, tells USA Today. “It helps assure that the men who get diagnosed actually need treatment.” He adds that men who are not screened have no reason to take the drug, because those not getting screened are unlikely to be unnecessarily diagnosed or treated.
In an accompanying editorial, Michael LeFevre, a family physician at the University of Missouri who sat on the task force, wrote that “men who are aware of and understand the benefits, risks and uncertainties associated with (the drug) for prevention may make a rational decision to take the drug to reduce the harm of screening.”
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