(HealthDay News) — For patients 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 Journal of Urology.

Researchers conducted an open-label, single-arm, phase 2 study testing 90 days of daily oral apalutamide in patients with low- to intermediate-risk prostate cancer on active surveillance. The percentage of patients with a negative biopsy immediately following treatment was the primary endpoint.

Of the 22 patients who completed 90 days of apalutamide with post-treatment biopsy, 15 had Grade Group 1 disease, and the others had Grade Group 2 disease. Seven patients had favorable- to intermediate-risk disease (30%).


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The researchers found that, on post-treatment biopsy, 13 of the patients (59%) had no residual cancer. There was a median of 364 days to first positive biopsy.

Apalutamide had a minimal and transient effect on quality of life, according to the researchers. More negative post-treatment biopsies were seen for patients with a higher baseline genomic risk score.

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

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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