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Neoadjuvant Hormonal Ablation, Imatinib Mesylate and Docetaxel Followed by Radical Prostatectomy for High-Risk Localized Prostate Cancer

Phase 2
Not Enrolling
Prostate Cancer

Thank you

Trial Information

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.

Inclusion Criteria:

- Patients with adenocarcinoma of the prostate that in the opinion of the surgeon is
resectable. Ductal adenocarcinoma of the prostate is included.

- All patients must be regarded as low anesthetic risk for radical prostatectomy and
confirm their intention to undergo radical prostatectomy at the end of the
neoadjuvant therapy.

- All patients must have at least one of the following high-risk features: clinical or
pathological T3 disease, or cT2c or PSA>20ng/ml or Gleason 8-10 adenocarcinoma or
clinical T2b and PSA>10ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging
system will be followed.

- Prior hormonal therapy up to 2 months is permitted; no concurrent ketoconazole is

- Patients must have adequate bone marrow function defined as an absolute peripheral
granulocyte count of >/= 1,500/mm3 and platelet count of >/= 100,000/mm3; adequate
hepatic function defined with a total bilirubin of aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) upper limits of normal; adequate renal function defined as serum creatinine clearance
>/= 40 cc/min (measured or calculated).

- Patients must sign a written informed consent form prior to treatment. All patients
must have a surgical and medical oncology consult prior to signing informed consent.

Exclusion Criteria:

- Patients with small cell or sarcomatoid prostate cancers are not eligible.

- Patients with clinical or radiological evidence of metastatic disease

- Prior chemotherapy or experimental agents

- Patients with severe intercurrent infection.

- Patients with The New York Heart Association (NYHA) Class III/IV congestive heart
failure, unstable angina or myocardial infarction (MI) in the last 6 months.

- Contraindications to corticosteroids.

- Uncontrolled severe hypertension, uncontrolled diabetes mellitus, oxygen-dependent
lung disease, chronic liver disease or human immunodeficiency virus (HIV) infection.

- Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3

- Overt psychosis, mental disability or otherwise incompetent to give informed consent
or history of non-compliance.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Achieving Pathological Complete Response

Outcome Description:

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.

Outcome Time Frame:

Every 3 months for 1 year, then every 6 months until disease progression or death

Safety Issue:


Principal Investigator

Paul Mathew, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2003

Completion Date:

February 2010

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Hormonal Ablation
  • Docetaxel
  • Imatinib Mesylate
  • STI571
  • Gleevec
  • Taxotere
  • Goserelin Acetate
  • Zoladex
  • Leuprolide
  • Lupron
  • Prostatic Neoplasms



U.T.M.D. Anderson Cancer CenterHouston, Texas  77030