Phase II Study of Neoadjuvant Hormonal Therapy Plus Docetaxel Followed by Radical Prostatectomy for Men With Proven or Suspected Node-positive Prostate Cancer
Advanced prostate cancer may be responsive to a combination of hormonal and chemotherapy
treatments. Researchers believe that the use of chemotherapy and hormonal therapy before
your scheduled surgery may help to affect or delay the progression of prostate cancer.
Before surgery, you will have imaging studies, including a chest x-ray, CT scan and a bone
scan. You may also have an MRI scan. These tests are being done to check on the status of
the disease. You will also have 3 tablespoons of blood drawn for routine blood tests,
All treatment will be given on an outpatient basis. Treatment should start as soon as
possible, within 14 days after registration. You will receive hormonal treatment once a
month for the 12 months before your surgery. Hormonal treatments will not continue after
You will be given dexamethasone, Benadryl® (diphenylhydramine) and Pepcid® (famotidine) , by
a vein in your arm or by central line in a vein before your therapy begins with docetaxel on
Day 1 of the first treatment cycle. Dexamethasone will help decrease bone marrow
inflammation. Diphenhydramine helps prevent allergic reactions. Famotidine protects you
against stomach irritation by decreasing the amount of acid in your stomach.
Docetaxel will be given through a needle in your vein (IV) once a week during the first 4
weeks of each 6-week period (called a study cycle). Each dose of docetaxel will take about
an hour to be given. The total treatment time to complete the docetaxel will be 3 study
cycles (18 weeks). Before each 6-week study cycle with docetaxel, you will come to the
clinic for a physical exam and routine blood tests (2 tablespoons).
After your treatment with docetaxel and hormones, you will then have an operation to remove
the prostate gland and the tumor. Your doctor will discuss the surgical procedure with you
in detail and explain the risks of the operation. You will need to sign a separate consent
form before undergoing the surgical procedure.
After surgery, you will be closely checked for any possible side effects. After completion
of the treatment, you will be monitored every 3 months for the first year and every 6 months
for the second year. You will also have 2 tablespoons of blood drawn for routine blood test
monitoring at every follow-up visit.
This is an investigational study. Docetaxel and the hormone treatments used in this study
are FDA approved medications for the treatment of prostate cancer. Up to 40 patients 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
Number of Patients Progression Free at 1 Year
Lance Pagliaro, MD, BA
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|