John P. Fruehauf, MD, PhD, University of California, Irvine
Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate
Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage II Prostate Cancer
This pilot phase II trial studies docetaxel and prednisone in treating patients with newly
diagnosed stage I-II prostate cancer undergoing prostatectomy. Drugs used in chemotherapy,
such as docetaxel, work in different ways to stop the growth of tumor cells, either by
killing the cells or by stopping them from dividing. Biological therapies, such as
prednisone, may stimulate the immune system in different ways and stop cancer cells from
growing. Giving docetaxel and prednisone together may kill more tumor cells.
Ages Eligible: 18 Years
Accepts Healthy Volunteers:
- Patient must have a histological diagnosis of adenocarcinoma of the prostate which is
measurable or evaluable Stage I or II.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
- Patient must have a pre-study PSA within 28 days prior to start of therapy.
- Patients who have received prior radiotherapy are not eligible.
- Patient must have an adequate renal function
- Men of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.
- Age > 18
- Patients must be able to take oral medications
- Patients with measurable metastatic diseases by a CT scan of the abdomen and pelvis
within 28 days and by a bone scan within 42 days prior to start of therapy.
- Patient must not have received chemotherapy, biologic therapy or any other
investigational drug for any reason within 28 days prior to start of therapy and must
have recovered from toxicities of prior therapy to grade 1 or less with the exception
- Patients must not be treated with non-steroidal anti-androgens (flutamide,
bicalutamide, nilutamide or ketoconazole).
- Patients must not take vitamins, herbs, or micronutrient supplement within 28 days
prior to start of therapy.
- Patients may not have ongoing problems with bowel obstruction or short bowel syndrome
characterized by grade 2 or greater diarrhea or malabsorptive disorders.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80
- Patients should not have psychological, familial, sociological, or geographical
conditions that do not permit medical follow-up or compliance with the study
- Patients should not have any medical life-threatening complications of their
- Patients should not have a known severe and/or uncontrolled concurrent medical
disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease,
active uncontrolled infection, or HIV).
- Patients should not have current, recent (within 4 weeks of the first infusion of
this study), or planned participation in an experimental drug study.
- Patients with history of myocardial infarction, cerebrovascular accident, transient
ischemic attack, or unstable angina within 6 months
- Patients with clinically significant peripheral vascular disease
- Patients with evidence of bleeding diathesis or coagulopathy
- Patients with central nervous system or brain metastases
- Patients who had major surgical procedure, open biopsy, or significant traumatic
injury within 28 days prior to Day 0, anticipation of need for major surgical
procedure during the course of the study
- Patients with minor surgical procedures, fine needle aspirations or core biopsies
within 7 days prior to Day 0
- Patients with history of abdominal fistula, gastrointestinal perforation, or
- Patients with serious, non-healing wound, ulcer, or bone
- Patients who are diagnosed of any other malignancy except non-melanomatous skin
cancer in the past 5 years
- Patients receiving anticoagulation therapy (e.g. Coumadin) prior to registration
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Information objtained from ClinicalTrials.gov, on
4/21/2014. For additional information about
this and other clinical trials,
Please refer to this study by its ClinicalTrials.gov identifier: