drugset / Trial / NCT04523207
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
NaSingle-groupOpen-labelTreatment
Summary
Main Study: The purpose of main study is to assess if the combination of apalutamide and androgen deprivation therapy (ADT) in participants with high-risk localized prostate cancer improves the biochemical recurrence (BCR) free rate. Sub-study: The purpose of the sub-study is to assess if the co administration of apalutamide and relugolix is able to maintain castrate levels of testosterone.
Timeline
- Start
- 2020-08-19
- Primary completion
- 2023-10-23
- Completion
- 2023-10-25
Publications
- Shore N, Hafron J, Saltzstein D, Brown G, Belkoff L, Aggarwal P, Phillips J, Bhaumik A, McGowan T. Apalutamide for High-Risk Localized Prostate Cancer Following Radical Prostatectomy (Apa-RP). J Urol. 2024 Nov;212(5):682-691. doi: 10.1097/JU.0000000000004163. Epub 2024 Aug 1.
- Brown G, Belkoff L, Hafron JM, Saltzstein DR, Potdar R, Bhaumik A, Phillips J, McGowan T, Shore ND. Coadministration of Apalutamide and Relugolix in Patients with Localized Prostate Cancer at High Risk for Metastases. Target Oncol. 2023 Jan;18(1):95-103. doi: 10.1007/s11523-022-00932-8. Epub 2022 Dec 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apalutamide | Small molecule | 240 mg | Oral |
| Subject | Relugolix | Small molecule | 120 mg | Oral |