drugset / Trial / NCT03230734
Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer
Phase 2
Active not recruiting
70 enrolled
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Bayer · collab
RandomizedSequentialOpen-labelTreatment
Summary
Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC) Open-label, randomized phase II trial in patients with symptomatic bone-only metastatic castration-resistant prostate cancer. Eligible patients are randomly assigned into two arms: * Arm A: radium-223 initially followed by docetaxel plus prednisone at the time of progression (the second step is optional according to clinical evolution of disease) * Arm B: docetaxel plus prednisone initially followed by radium-223 at the time of progression (the second step is optional according to clinical evolution of disease).
Timeline
- Start
- 2017-09-01
- Primary completion
- 2025-07
- Completion
- 2025-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Radium-223 dichloride | Other / unclassified | 0.055 mbq/kg | Intravenous |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |