Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: Docetaxel; Goserelin; Imatinib Mesylate; Leuprolide

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 ofaminotransferase (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 years.

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