Trevor J. Royce, MD
A prostate-specific antigen (PSA) nadir (the lowest level a PSA drops following treatment) greater than 0.5 ng/mL following radiation and androgen deprivation therapy seems to identify men prior to PSA failure who are at high-risk for death, and would thus require more aggressive treatment for their prostate cancer, according to the results of a recent study in JAMA Oncology
, Trevor J. Royce, MD, senior resident, Department of Radiation Oncology, Brigham and Women's Hospital, discussed the findings of this study and how they may change designs of future clinical trials in prostate cancer.
OncLive: What was the rationale for conducting this study?
: Clinical trials in early prostate cancer can take a long time to report on, sometimes over a decade. People have been investigating early-reporting endpoints, and these have been proposed, but it’s been unknown until now which may be better than the other. And these early endpoints would be a way to speed up the results of trials.
How was your study carried out, and what were the most significant findings?
We used data from a randomized trial of 206 men who were treated with radiation or radiation and 6 months of hormone therapy. Then we compared early markers for prostate cancer death to identify who, in that cohort, would be at risk for dying early from their prostate cancer.
We found that, of all the possible early endpoints that we studied, how low a PSA blood test falls to after treatment with radiation and hormone therapy, appears to be the best predictor. Specifically, if the PSA does not get below half a point, then that patient is very likely to die of prostate cancer if given standard treatment for recurrence. These men deserve enrollment on clinical trials in order to properly save their lives.
What impact do you expect these results to have on the overall treatment landscape?
This newly defined endpoint can be used to enroll men today on clinical trials whose hope it is to take a prostate cancer that appears to be aggressive based on this metric, and potentially incurable, and make it curable with more aggressive care under the context of a clinical trial.
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