Neoadjuvant Hormonal Ablation, Imatinib Mesylate and Docetaxel Followed by Radical Prostatectomy for High-Risk Localized Prostate Cancer
Docetaxel is a drug that was designed to help kill cancer cells. Imatinib mesylate is a drug
designed to block cancer cells from growing and dividing. Hormonal treatment with Lupron
(leuprolide) or Zoladex (goserelin acetate) is used to lower testosterone levels in the body
because prostate cancer cells need testosterone to survive. All patients will have their
prostate gland removed after treatment with these drugs.
Before treatment starts, you will be asked questions about your medical history and have a
complete physical examination. You will have blood drawn (2 tablespoons) for routine blood
tests. You will be asked questions about any medications you are currently taking and have
taken in the past. You will have an electrocardiogram (ECG - a test that measures electrical
activity of the heart). As part of your standard care for prostate cancer, you will also
have a computed tomography (CT) scan (or magnetic resonance imaging ((MRI)) scan) of the
abdomen and pelvis along with a bone scan (x-rays of the bones) to see if the prostate
cancer has moved to other parts of your body.
For this study, you will receive hormone injections to lower the levels of testosterone in
the blood. You will also take imatinib mesylate capsules by mouth and receive treatment
with docetaxel by vein to help kill the cancer cells before surgery.
You will receive hormone therapy with either leuprolide or goserelin acetate injections,
whichever your doctor feels will give you the most benefit. The hormone injections will be
given every other month or every 3 months. During treatment with the hormones, you will
also take an anti-androgen drug called Casodex (bicalutamide) by mouth for up to 2 weeks.
This drug is being used to help decrease the risks of developing side effects due to the
hormone injections (this is the standard of care with hormone treatments). You will take
imatinib mesylate capsules every day for 6 weeks starting with the hormone treatments. You
will also receive treatment with docetaxel. Docetaxel injections are given by vein over 60
minutes once a week for 4 weeks in a row. This will be followed by 2 weeks with no
docetaxel. This 6 week period is considered a course of treatment. You will have up to 3
courses of treatment (18 weeks) with docetaxel. After this treatment is complete, you will
have prostate surgery within 4 weeks or when you have fully recovered from treatment.
During treatment, your general health will be monitored and you will have physical exams and
blood tests (about 1-2 tablespoons) often to make sure that you are tolerating the treatment
safely. If the disease gets worse or you experience intolerable side effects, you will be
taken off the study and your doctor will discuss other treatment options with you.
Before surgery, you will be given a general anesthetic. An incision (cut) will be made in
your abdomen (lower stomach area) and your prostate gland and lymph nodes in the pelvis will
be removed. Before the procedure, the risks will be explained to you and you will need to
sign a separate consent form.
After surgery, you will have check-up visits every 3 months for 1 year, then every 6 months
for the rest of your life. At these visits, you will have a physical exam and around 1-2
tablespoons of blood collected for routine lab tests. If your doctor feels it is necessary,
you may also have CT scans, bone scans, and/or x-rays. These tests are being done to check
if the cancer has come back. If the cancer comes back, you will be removed from the study
and your doctor will discuss treatment options with you.
This is an investigational study. The leuprolide or goserelin acetate injections,
bicalutamide tablets, imatinib mesylate capsules, and docetaxel injections are all FDA
approved and are commercially available. Up to 36 participants will take part in this study.
All will be enrolled at UT MD Anderson Cancer Center.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Achieving Pathological Complete Response
Probability of response, defined as pathological complete remission based on tissue obtained at surgery. Pathological Complete Response (pCR): Patients without gross or microscopic evidence of residual disease at Radical Prostatectomy defined as pCR.
Every 3 months for 1 year, then every 6 months until disease progression or death
Paul Mathew, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|