A landmark study has found that the prostate cancer drug apalutamide, when combined with standard hormone therapy, significantly reduces the risk of cancer recurrence and spread. The findings, presented at the American Society of Clinical Oncology (ASCO) meeting, could reshape treatment for high-risk prostate cancer patients.
Core Findings
The phase 3 PROTEUS trial, involving over 2,100 men across 18 countries, demonstrated that adding apalutamide to androgen deprivation therapy (ADT) lowered the risk of cancer returning by 29% and reduced the risk of metastasis or death by 20%. Patients who received the combination therapy remained cancer-free for an average of nearly five years, compared to around three years for those on ADT alone.
Treatment Details
Participants received ADT for six months before and after prostate removal surgery, with half also receiving apalutamide. The drug, marketed as Erleada, blocks testosterone from fueling tumor growth. While urinary tract infections were common in both groups, rashes were the most frequent side effect leading to discontinuation of apalutamide.
Broader Implications
The study suggests that apalutamide could become a new standard for high-risk prostate cancer patients, many of whom currently face recurrence despite surgery and radiation. Johnson & Johnson, the drug's manufacturer, highlighted that nearly 40% of the 330,000 U.S. prostate cancer cases annually are classified as high-risk. Experts at ASCO described the results as 'paradigm-changing,' potentially altering treatment approaches for localized or locally advanced prostate cancer.
Ongoing Research
Researchers are now investigating the optimal duration of apalutamide treatment. Preliminary data suggests that extending therapy to a full year before and after surgery may further improve outcomes, with patients in this group going an average of six years before needing additional treatment.