Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer
Drug: Neoadjuvant Hormonal Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Neoadjuvant Hormonal Therapy Plus Docetaxel Followed by Radical Prostatectomy for Men With Proven or Suspected Node-positive Prostate Cancer|
- Number of Patients Progression Free at 1 Year [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]Proportion of patients prostatic specific antigen (PSA) progression-free at one year and the proportion with pathologic complete response at the time of prostatectomy estimated with a 95% exact binomial confidence interval. In addition, the time to PSA progression from radical prostatectomy estimated using Kaplan-Meier methodology.
|Study Start Date:||May 2005|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Neoadjuvant Hormones + Docetaxel
Neoadjuvant Hormonal Therapy plus Docetaxel followed by Radical Prostatectomy
Drug: Neoadjuvant Hormonal Therapy
Monthly or quarterly LHRH Agonist Depot injection (leuprolide or goserelin acetate) for one year.
Other Names:Drug: Docetaxel
35 mg/m2 by vein (IV) on Day 1, 8, 15 and 22 every 6 weeks.
Other Name: Taxotere
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, before treatment.
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 the surgery.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01076335
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77007|
|Study Chair:||Lance Pagliaro, MD, BA||M.D. Anderson Cancer Center|