Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00500110
- Run by
- M.D. Anderson Cancer Center
- People needed
- 39
- Starts
- 2003-06-01
- Expected to finish
- 2010-02-01
- Last updated by the study team
- 2015-04-28
Who can join
Age: any. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- U.T.M.D. Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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