drugset / Trial / NCT00734851
Multimodality Phase II Study in Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm phase II study of docetaxel, prednisone, and sunitinib systemic therapy followed by salvage external beam radiation therapy for men who have experienced PSA recurrence following initial radical prostatectomy for prostate cancer. The primary aim is the rate of progression-free survival at 2 years as measured by lack of PSA progression and no evidence of disease. We hypothesize that this aggressive initial systemic therapy will improve the long term remission rates for men who are undergoing salvage radiation therapy for PSA recurrence in the absence of metastatic disease.
Timeline
- Start
- 2008-12
- Primary completion
- 2014-09
- Completion
- 2014-11
Outcome
Outcome not reported
Stopped: “Dose Limiting Toxicities”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 70 mg/m2 | — |
| Subject | Sunitinib | Small molecule | 37.5 mg | Oral |