NEW YORK – A new update to guidelines from the American Urological Association for the management of patients with localized early-stage prostate cancer has endorsed selective use of genomic biomarker tests.
The AUA's 2022 update now states that clinicians may use tissue-based genomic biomarkers when added risk-stratification could alter their clinical decision-making. However, the guidelines don't endorse routine use of these tests, citing a lack of validation evidence that meets a high enough bar.
Despite the cautious take, test-makers greeted the new recommendations as positive.
"We're pleased that the updated guidelines recognize the impact genomic assays can have on treatment decision-making for men with localized prostate cancer," Daniel Shoskes, Exact Sciences' medical director of urologic oncology medical affairs, said in a statement.
The guidelines said available commercial tests, including Oncotype Dx, Myriad Genetics' Prolaris, and Veracyte's Decipher, can predict adverse pathology as well as the risks of biochemical recurrence, metastasis, and prostate cancer death.
However, the authors wrote that most of these tests' validation evidence failed to meet their bar for review due to the use of surgical rather than biopsy specimens. And even the studies that did use biopsies still largely didn't pass muster.
"Two studies using biopsy data have shown that a cell cycle progression panel (Prolaris) score was associated with the risks of biochemical recurrence, metastatic disease, and prostate cancer death; however, only one of those studies met inclusion criteria," the group wrote. Studies of Oncotype Dx using needle biopsy tissue also failed to reach a high enough bar.
Based on the level of existing data, the guidelines panel decided to recommend against routine use but allow for clinicians to elect to use tests when added risk stratification may alter their course of treatment.
Cited examples include patients with high-volume Gleason score 6 cancer and some patients with intermediate-risk cancer who are interested in active surveillance.
"Prospective validation of the predictive capacity of genomic classifiers in localized disease will be important to support widespread use for treatment selection," the authors wrote.