Posted: Friday, July 21, 2023
Xin Gao, MD, of Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, and colleagues presented the study design for an ongoing phase II clinical trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS5111). The ARAMON study will compare the effects of darolutamide and enzalutamide monotherapy on serum testosterone levels in patients with hormone-naive prostate cancer who experienced biochemical recurrence after localized treatment. The investigators will assess whether the low blood-brain barrier penetration of darolutamide causes lower serum testosterone elevations than those seen with enzalutamide, possibly leading to fewer associated feminizing adverse events. The first patient was enrolled in January 2023.
During the lead-in phase of the study, 25 patients will receive darolutamide twice daily for 52 weeks. If specific criteria based on the serum testosterone level increase from baseline are met at week 12, the study will proceed to a randomized phase. In this phase, the effects of darolutamide (600 mg twice daily) will be compared with those of enzalutamide (160 mg once daily) for an additional 52 weeks.
The primary endpoint of both phases is the change in serum testosterone level from baseline to week 12. Secondary endpoints will include changes in serum testosterone levels at weeks 24 and 52, prostate-specific antigen levels, markers for glucose and lipid metabolism, endocrine function related to sex hormones, safety, and quality of life.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.