Apalutamide Safe for Men With Prostate Cancer on Active Surveillance

Greater number of negative posttreatment biopsies seen among men with higher baseline genomic risk score

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Medically Reviewed By:
Mark Arredondo, M.D.

WEDNESDAY, Jan. 18, 2023 (HealthDay News) -- For men with low- to intermediate-risk prostate cancer on active surveillance, the negative repeat biopsy rate is high following 90 days of apalutamide, according to a study published in the February issue of The Journal of Urology.

Michael T. Schweizer, M.D., from the University of Washington in Seattle, and colleagues conducted an open-label, single-arm, phase II study testing 90 days of oral apalutamide daily in men with low- to intermediate-risk prostate cancer on active surveillance. The percentage of patients with a negative biopsy immediately following treatment was examined as the primary objective.

Of the 22 men who completed 90 days of apalutamide with posttreatment biopsy, 15 had Grade Group 1 disease and the others had Grade Group 2 disease; seven had favorable- to intermediate-risk disease (30 percent). The researchers found that on posttreatment biopsy, 13 of the patients (59 percent) had no residual cancer. There was a median of 364 days to first positive biopsy. A minimal and transient effect was seen for apalutamide on quality of life. A greater number of negative posttreatment biopsies was seen for those with a higher baseline genomic risk score in the decipher risk classifier.

"Of note, not only did low-risk patients appear to benefit, but we also saw favorable pathological effects in those with higher-risk features (i.e., Grade Group 2 disease, high genomic risk) -- indicating that men at risk for needing local treatment could benefit from this approach," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Janssen, which manufactures apalutamide and provided drug and funding support for the study.

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