Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Imatinib Mesylate; Leuprolide; Goserelin Acetate
Intervention description: 30 mg/m^2 by vein (IV) Weekly Over 60 Minutes on Days 1, 8, 15, and 22. This will be followed by 2 weeks with no docetaxel.; 600 mg by mouth (PO) Daily x 42 Days.; Hormone injections given every other month or every 3 months, as determined by the doctor.; Hormone injections given every other month or every 3 months, as determined by the doctor.
Intervention MeSH terms: Docetaxel; Imatinib Mesylate; Leuprolide; Goserelin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: Male
Healthy volunteers: No
Keywords: Prostate Cancer; Hormonal Ablation; Docetaxel; Imatinib Mesylate; STI571; Gleevec; Taxotere; Goserelin Acetate; Zoladex; Leuprolide; Lupron

Summary:

      Primary Objective:

      1. To evaluate the pathological complete response rate to neoadjuvant hormonal ablation,
      Imatinib and Docetaxel (HID) in high-risk localized prostate cancer.

      Secondary Objectives:

        1. To describe the time to prostate specific antigen (PSA)-progression after neoadjuvant
           HID and radical prostatectomy in high-risk localized prostate cancer.

        2. To correlate pathological response with modulation of the Platelet-Derived Growth Factor
           Receptor (PDGFR) pathway.
    

Eligibility criteria:

        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
             permitted.

          -  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 </= 1.5 mg/dl and aspartate
             aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) </= 2 times the
             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
             years.

          -  Overt psychosis, mental disability or otherwise incompetent to give informed consent
             or history of non-compliance.