Darolutamide + Hormone Therapy for Granulosa Cell Tumor

This trial tests a combination of three medications—darolutamide, leuprolide acetate, and exemestane—to evaluate their effectiveness in treating ovarian granulosa cell tumors that have recurred after earlier improvement. Darolutamide, a hormone therapy, blocks hormones that can promote tumor growth. Leuprolide acetate and exemestane lower certain hormone levels in the body, potentially slowing or stopping tumor growth. The trial seeks participants with ovarian granulosa cell tumors that have returned after prior treatment and have progressed despite previous aromatase inhibitor use. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your current medications with the trial team to get specific guidance.

Research has shown that the treatments in this trial have been safe in past studies. Darolutamide, which blocks certain hormones, has been well tolerated by patients with prostate cancer. It helps control the disease for a long time and is safe for extended use.

Exemestane, which reduces estrogen levels, is generally safer and more effective than similar treatments. It has been used successfully in various situations.

Leuprolide acetate also has a good safety record. Specifically, in studies, it helped 66% of patients with recurrent granulosa cell tumors, a type of ovarian tumor. These results support its safe use for these tumors.

Researchers are excited about this treatment combination because it brings a fresh approach to tackling granulosa cell tumors. While standard treatments often focus on surgery and traditional chemotherapy, this combination uses darolutamide, exemestane, and leuprolide acetate, which together offer a novel hormonal angle. Darolutamide is particularly intriguing as it targets androgen receptors, which is a different mechanism from typical cancer treatments. This combination aims to disrupt the tumor's growth signals more effectively and could potentially offer a new lifeline for patients who haven't responded well to current options.

This trial will evaluate the combination of darolutamide, leuprolide acetate, and exemestane for managing ovarian granulosa cell tumors. Research suggests that darolutamide blocks male hormones, stopping tumor growth. Exemestane lowers estrogen levels, which also helps slow or stop tumor growth. One study showed that leuprolide acetate controlled these tumors in 66% of cases. Together, these treatments might shrink or stabilize tumors or prevent their recurrence.¹²⁴⁶⁷