Erleada May Slow Prostate Cancer Progression During Active Surveillance

Adding 90 days of the medication Erleada (apalutamide) to active surveillance tended to lower the risk of disease growth in patients with low- or intermediate-risk prostate cancer, according to research published in The Journal of Urology.

The phase 2 study involved 22 men with prostate cancer (average age, 67 years) who were treated with 90 days of Erleada before undergoing a follow-up biopsy. Findings showed that 13 patients (59%) had no evidence of residual disease on their post-treatment biopsy.

At one year follow-up, seven (33%) patients were cancer-free at one year, and four patients (21%) were cancer-free at two years.

There was an increase in prostate-specific antigen (PSA) levels after stopping Erleada treatment, but at 365 days post-treatment, researchers did not observe a significant difference in PSA levels compared to baseline.

"Our preliminary findings support further studies to determine whether adding hormonal therapy might aid in reducing or preventing progression of early-stage prostate cancers during (active surveillance),” lead author Dr. Michael T. Schweizer, of University of Washington and Fred Hutchinson Cancer Center in Seattle, said in a press release about the findings.

Active surveillance is a care method for low-risk prostate cancer that involves not taking drugs but undergoing regular follow-up with clinicians to monitor the cancer. In doing so, patients may be able to avoid or delay treatments such as surgery or radiation, which could come with side effects and impact quality of life.

The study findings also showed that Erleada itself did not have a major impact on patients’ quality of life, with most side effects being mild. Common side effects were fatigue, hormone imbalance, joint and muscle pain, taste changes, rash, cognitive impairments, hot flashes, anorexia, dry skin, libido decrease, itchy skin, nausea and weight loss.

While quality of life scores decreased from day 1 to day 91, they were back near baseline by day 180, the researchers noted.

“(Erleada), an androgen receptor inhibitor, is an ideal compound to evaluate in this population given its proven antitumor efficacy in men with advanced prostate cancer and the fact that it does not impair the hypothalamic-pituitary-gonadal axis,” the study authors wrote, highlighting that Erleada increases testosterone levels.

“The predicted consequence is that, following treatment discontinuation, the side effects of hypogonadism (body not producing enough testosterone) should dissipate rapidly, leading to minimal disruption in overall quality of life,” they wrote.

Looking forward, the researchers explained that a larger, randomized trial will be needed to better determine and understand the potential benefit of systemic therapies like Erleada for patients undergoing active surveillance for prostate cancer.

“Based on these findings, future prospective studies of (Erleada) in men with prostate cancer followed on (active surveillance) are justified,” they wrote.

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