drugset / Trial / NCT04666129
Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).
Timeline
- Start
- 2021-02-18
- Primary completion
- 2024-05-28
- Completion
- 2024-05-28
Publications
- De La Cerda J, Belkoff L, Courtney KD, Diamond E, D'Olimpio J, Dunshee C, Gervasi L, Goodman M, Mittal K, Morris D, Sieber P, Tutrone R, Ryan M, Zhong Y, Ufer M, Shore N. Safety and Tolerability of Relugolix in Combination with Abiraterone or Apalutamide for Treatment of Patients with Advanced Prostate Cancer: Data from a 52-Week Clinical Trial. Target Oncol. 2025 May;20(3):503-517. doi: 10.1007/s11523-025-01139-3. Epub 2025 Apr 4.
- De La Cerda J, Dunshee C, Gervasi L, Sieber P, Belkoff L, Tutrone R, Lu S, Gatoulis SC, Brown B, Migoya E, Shore N. A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer. Target Oncol. 2023 May;18(3):383-390. doi: 10.1007/s11523-023-00967-5. Epub 2023 Apr 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 500 mg | Oral |
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Apalutamide | Small molecule | 240 mg | Oral |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 5 mg | Oral |
| Subject | Relugolix | Small molecule | 120 mg | Oral |
| Subject | Relugolix | Small molecule | 240 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | 4 mg | Oral |