drugset / Trial / NCT03358563
Pilot Trial of Chemohormonal Therapy Followed by Prostatectomy in High Risk Prostate Cancer
Phase 0
Completed
30 enrolled
University of Wisconsin, Madison
Prostate Cancer Foundation · collabUnited States Department of Defense · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a pilot multimodality treatment approach trial with androgen deprivation therapy in combination with docetaxel chemotherapy followed by radical prostatectomy in patients with newly diagnosed high-risk and oligometastatic prostate cancer. This study aims to evaluate the rates of complete pathologic response (pCR) at the time of prostatectomy as well as PSA response, time to PSA recurrence and safety and toxicity of the combination. This study will be heavily embedded with biomarker analyses of the tumor and tumor cells in circulation as well in the bone marrow before and after treatment and will also include imaging analyses using a novel positron emission tomography (PET) imaging technology.
Timeline
- Start
- 2018-01-17
- Primary completion
- 2021-08-10
- Completion
- 2022-09-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bicalutamide | Other / unclassified | 50 mg | Oral |
| Subject | Degarelix | Other / unclassified | 80 mg | Subcutaneous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |