Darolutamide, Leuprolide Acetate and Exemestane Combination for Recurrent Adult-Type Ovarian Granulosa Cell Tumor

This study aims to explore the effectiveness of a combination of three medications—darolutamide, leuprolide acetate, and exemestane—in treating recurrent adult-type granulosa cell tumors of the ovary. These types of tumors are rare and often return after initial treatment, so finding effective therapies is crucial. The study's main goal is to determine how well this combination works in shrinking the tumors and prolonging the time patients live without the disease getting worse. Additionally, the study seeks to understand how long the positive effects of the treatment last, overall survival rates, and any potential side effects. Participants in this study take exemestane orally once a day and darolutamide orally twice a day, starting a week or two before the first treatment cycle. Leuprolide acetate is administered through an injection into the muscle at the beginning of each treatment cycle. Each cycle lasts 28 days and continues unless the disease progresses or side effects become too severe. Throughout the study, participants undergo various imaging tests and blood sample collections to monitor the treatment's impact. Tissue samples are also collected during the screening phase. After the treatment ends, participants have regular follow-ups every three months for two years, then every six months for three more years, to track their health and any long-term effects of the treatment.