drugset / Trial / NCT05189457
First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer
Phase 2
Active not recruiting
32 enrolled
H. Lee Moffitt Cancer Center and Research Institute
BeiGene · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical research is to find if sequential therapy with combined androgen deprivation or hormonal therapy with luteinizing hormone release hormone (LHRH) analog plus a new hormonal agent (abiraterone, enzalutamide, or apalutamide) followed by chemohormonal therapy with docetaxel and LHRH analog would improve the outcome of high risk metastatic/stage IV prostate cancer.
Timeline
- Start
- 2022-01-25
- Primary completion
- 2027-07-15
- Completion
- 2028-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Degarelix | Other / unclassified | — | — |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Leuprolide | Other / unclassified | — | — |
| Background | Relugolix | Small molecule | — | — |
| Background | Triptorelin | Other / unclassified | — | — |