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Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study

18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Neoadjuvant Therapy With Docetaxel and Ketoconazole in Patients With High-Risk Prostate Cancer: A Pilot Study

Inclusion Criteria:

- Patients must have histologically proven adenocarcinoma of the prostate.

- Patients must meet at least one of the following high risk criteria:

- PSA > 20

- Gleason score 8 or greater

- Presence of pathological Gleason grade 4 or higher as the majority sum on biopsy

- Greater than 50% of cores at time of biopsy positive for cancer

- Clinical Stage T3 Disease

- Patients must have PS of 0-1(ECOG) and medically deemed a surgical candidate for
radical prostatectomy.

- Age > or = to 18.

- Patients with a pre-existing peripheral neuropathy of equal to or greater than
grade two are ineligible.

- Serum Creatinine must be < or equal to 2.0mg/dl.

- Patients must currently not receiving any drug which is metabolized by
cytochrome P450-3A4 including the statins, cyclosporin, terfenadine and

- Prior to receiving any dose of docetaxel, patients should have absolute
neutrophil counts > 1,500, hemoglobin > 8.0 g/dl and platelet counts >

- Patients with bilirubin elevated above institutional upper limit of normal
(ULN)must be excluded. Transaminases (SGOT and/or SGPT) may be up to 5.0 x
institutional upper limit of normal (ULN) if alkaline phosphatase is < ULN, or
alkaline phosphatase may be up to 5 x ULN if transaminases are < ULN. However,
patients who have both transaminase elevation > 1.5 x ULN and alkaline
phosphatase > 2.5 x ULN are not eligible for this study (due to decrease
clearance of docetaxel and increased risk of toxicity).

- Patients receiving concurrent warfarin are eligible but require monitoring of
protime on a weekly basis.

- Patients with clinical stage T4 disease are not eligible.

- Patients must not had have received prior treatment with surgery, radiation or
hormone deprivation.

- Patients with other primary malignancies previously treated with
chemotherapeutic agents are not eligible.

- Patients must not have had a history of peptic ulcer disease requiring treatment
with surgery or endoscleral.

- Patients requiring corticosteroids for other systemic diseases are not eligible.

- Patients with a history of severe hypersensitivity reaction to docetaxel or
other drugs formulated with polysorbate 80 are not eligible.

- All patients must sign informed consent.

- Men of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the pathologic response rate of neoadjuvant therapy with the combination of docetaxel and ketoconazole given to patients who are at a high risk of recurrence of prostate cancer.

Outcome Time Frame:

One year

Safety Issue:



United States: Food and Drug Administration

Study ID:

Sanofi-Aventis IST 16167



Start Date:

September 2004

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Neoadjuvant
  • Prostatic Neoplasms



Kansas City VAMC Kansas City, Missouri  64128