drugset / Trial / NCT02059213
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
Phase 2
Completed
72 enrolled
University of Michigan Rogel Cancer Center
City of Hope Medical Center · collabJohns Hopkins University · collabNorthwestern University · collabThomas Jefferson University · collabUniversity of Utah · collabVanderbilt-Ingram Cancer Center · collabWashington University School of Medicine · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer. The investigators hypothesize that the addition of Palbociclib to initial ADT (Androgen Deprivation Therapy) in patients with newly metastatic RB-positive prostate cancer may significantly increase the efficacy of ADT.
Timeline
- Start
- 2014-06
- Primary completion
- 2017-09-09
- Completion
- 2019-06-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Palbociclib | Small molecule | 125 mg | Oral |
| Background | Bicalutamide | Other / unclassified | 50 mg | Oral |
| Background | Goserelin | Other / unclassified | — | Other |
| Background | Leuprolide | Other / unclassified | — | Other |