“From our results, the Decipher test helps reassure low-risk patients that observation may be warranted or confirm that high-risk patients need additional treatment,” says study author John L. Gore, MD, MSHS.
The genomic Decipher test, which predicts metastasis risk after radical prostatectomy, influences providers' decision-making for post-surgery adjuvant and salvage treatment, according to research presented at the AUA annual meeting.
“The Decipher test is unique in that it applies a genomic signature to the prediction of clinical metastases at 5 years post-prostatectomy,” said presenting author John L. Gore, MD MSHS, of the University of Washington School of Medicine and Fred Hutchinson Cancer Research Center, Seattle. “It is not the first genomic test, but most of the available tests are being applied in the pre-treatment space, to either reassure patients about active surveillance or support decisions to undergo definitive treatment. This test, in our study, is being applied to the clinical situations where patients and their providers are trying to navigate complex decisions regarding adjuvant and salvage therapy after prostatectomy.”
Dr. Gore and colleagues studied 150 patients considering adjuvant radiation therapy and 115 patients considering salvage radiation therapy. Providers caring for these patients submitted their recommendations for management before processing the Decipher test and again after receiving the test’s results. The patients submitted validated surveys on prostate cancer-specific quality of life, decision quality, and prostate cancer-related anxiety, according to the study’s abstract.
Researchers found that the test influences providers’ management recommendations. Low-risk patients, based on the Decipher test, are more likely to receive observation recommendations. High-risk patients are more likely to receive recommendations to undergo adjuvant or salvage treatments, usually with radiation therapy, according to Dr. Gore.
More specifically, prior to the Decipher test, providers recommended observation for 89% of adjuvant patients and 58% of salvage patients. Post Decipher, 18% of treatment recommendations changed in the adjuvant group, including 31% of high-risk Decipher patients, and 32% of providers’ recommendations changed in the salvage group, including 56% of high-risk Decipher patients, the study found.
Next: Higher perceived decision quality observed
Researchers also found that the inclusion of the Decipher test in clinical care was associated with higher perceived decision quality among patients and providers.
“In other words, patients who see their Decipher score, and providers who see their patients’ Decipher scores, have less uncertainty about their treatment recommendations,” Dr. Gore told Urology Times.
Administering the test, according to Dr. Gore, is not time consuming. It is a send-out test, however, so it might require an additional communication with the patient to review implications of the test results, he said.
“The main indication discussed in our study is to help guide men considering adjuvant radiation therapy, when they had high-risk features at the time of radical prostatectomy, [such as] nonorgan-confined prostate cancer or positive margins, [as well as] when their PSA is rising after prostatectomy. From our results, the Decipher test helps reassure low-risk patients that observation may be warranted or confirm that high-risk patients need additional treatment,” Dr. Gore said.
Dr. Gore and colleagues are completing their analysis of the data from follow-up visits to evaluate the treatments that were actually received among study patients and their follow-up decision quality. They also will assess the impact of prostate cancer-specific quality of life on the treatment decisions and decision quality outcomes that they observed, he said.
But while the test appears to improve provider and patient confidence, it has yet to prove it leads to better outcomes.
“We have not yet proven that the decisions made on the basis of these genomic tests are the ‘correct’ decisions. That is, when we make a decision to observe a rising PSA, is that associated with better health outcomes? And when we make a decision to treat someone with adverse features at the time of radical prostatectomy, is that associated with better health outcomes?” Dr. Gore said. “That requires a comparison of patients who view their Decipher test results with those whose adjuvant and salvage therapy decisions are informed by clinical and pathological variables alone.”
GenomeDx Biosciences provided funding for the study. Several of Dr. Gore’s co-authors are employees, consultant/advisers, investigators, board members/officers/trustees, and/or have an investment interest in GenomeDx Biosciences.
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