Applying the ProtecT Trial data to minority populations: OHSU researchers raise concerns

One in nine men in the United States will be diagnosed with prostate cancer in his lifetime. It is one of the leading causes of cancer deaths for men — especially for African American men, who are 60 percent more likely than white men to develop the cancer. African American men are not only more likely to get the disease, they tend to be diagnosed later and with a more aggressive form.

Co-author Timur Mitin
Co-author Timur Mitin, assistant professor of radiation medicine at the OHSU School of Medicine and medical director of the Tuality/OHSU Cancer Center

Radical prostatectomy and radiation therapy are the two definitive treatment options with high cure rates for patients with localized prostate cancer. However, some men may not need a definitive treatment and could simply be managed by a program of active surveillance, with definitive treatment options reserved only for patients who show evidence of tumor progression.  The largest-ever randomized controlled trial of treatment for prostate cancer found that active surveillance of the disease is as effective as surgery or radiotherapy in terms of survival at 10 years. The study, the Prostate Testing for Cancer and Treatment trial, was the first to directly compare these modalities in a randomized setting

In a JAMA Oncology opinion piece, Shearwood McClelland, M.D., and Timur Mitin, M.D., Ph.D., question whether this data should be applied to all patients, particularly African American patients. The ProtecT trial, led by researchers at the Universities of Oxford and Bristol at nine centers in the United Kingdom, grossly underrepresented minorities. Fewer than 1 percent of patients were of African descent, a number far smaller than the 13.8 percent of the U.S. population represented by African Americans according to the most recent U.S. Census.

McClelland, clinical research assistant in the Department of Radiation Medicine, and Mitin, assistant professor in the Department of Radiation Medicine at the OHSU School of Medicine and medical director of the Tuality/OHSU Cancer Center, argue that although active surveillance should still be regarded as the first choice treatment recommendation for all patients with a new diagnosis of low-risk prostate cancer, nonwhite patients should be aware that the results of the ProtecT trial may not be applicable to them and therefore there is a potential risk that active surveillance results may not be in line with definitive treatment options.

So that patients can make the most informed decision, the significant limitations of the ProtecT trial should be addressed with patients during multi-disciplinary discussions of treatment options. And if nonwhite men with localized prostate cancer choose the active surveillance option, their surveillance strategy must be more stringent than the one used for U.K. patients enrolled on the ProtecT trial.