A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer
The Study Drugs:
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die.
It is believed to be weakly effective at killing blood vessels in cancer cells as well.
Prednisone and docetaxel are commonly used to treat prostate cancer.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Day 1 of every 21-day study
"cycle", you will receive docetaxel through a needle in your vein over 1 hour.
Everyday, you will take prednisone by mouth 2 times a day (in the morning and evening). You
should take prednisone with meals.
You will take dexamethasone by mouth at 12 hours and 6 hours before you receive docetaxel.
This is to help reduce the risk of any allergic reaction and fluid retention. It is
important that you take this drug on schedule.
On Day 1 of each cycle, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight.
- Your performance status will be recorded.
- You will be asked about any drugs or treatments you may be receiving.
- You will be asked about any side effects you have experienced since your last visit.
Blood (about 2 teaspoons) will be drawn for routine tests and to test for PSA and
On Day 1 of Cycle 3, blood (about 2 teaspoons) will be drawn to test for PDGFR and PDGF
If you complete 2 cycles or more, you will be eligible to have surgery as part of this
If you are eligible, no more than 21 days after your last dose of docetaxel, you will have
surgery to remove your prostate gland. You will sign a separate consent for this surgery,
which will describe the procedure and its risks in detail.
Before surgery, probably at your pre-surgical visit, blood (about 2 teaspoons) will be drawn
to test for PDGFR and PDGF levels.
Length of Study:
You will take the study drug for up to 4 cycles before having surgery. You will be off study
treatment after you have surgery. You will be taken off study early if you experience
intolerable side effects or the disease gets worse.
This is an investigational study. Docetaxel given with prednisone is commercially available
and FDA approved for the treatment of prostate cancer.
Up to 28 participants will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR)
PDGFR will be estimated for each patient based on blood samples taken at day 0 and at day 42 using the Bayesian survival time regression model.
Lance Pagliaro, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board