Phase II Study to Determine the Effects of Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate in Patients Who Are Scheduled for Radical Prostatectomy With Genomic Correlates of Pathological Response
I. To determine the rate of a 3-month prostate-specific antigen (PSA) decline of at least
30% by chemotherapy regimen of docetaxel and prednisone in patients with stage I/II prostate
cancer, who are scheduled for prostatectomy.
II. To compare tumor, pathological and PSA responses to neoadjuvant docetaxel between
patients with intermediate and high grades of prostate cancer.
III. To obtain prostate specimens for genomic correlates with responses of the chemotherapy
regimen of docetaxel and prednisone.
Patients receive docetaxel intravenously (IV) over 60 minutes on days 1 and 2 and prednisone
orally (PO) twice daily (BID) on days 1-21. Treatment repeats every 21 days for 3 courses in
the absence of disease progression or unacceptable toxicity. Patients undergo prostatectomy
within 3 weeks after completion of chemotherapy.
After completion of study treatment, patients are followed up within 7 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA response rate (partial response (PR) + complete response (CR))
Expressed with two-sided exact binomial confidence intervals. Significance of changes between pre- and after-treatment PSA or testosterone will be determined by the Wilcoxon signed-rank test. The difference of response rates between different pre-treatment pathological stages or Gleason scores will also be examined by Fisher's exact test. Associations between PSA response and tumor response, and PSA response and gene expression will also be examined by Fisher's exact test.
John P. Fruehauf, MD, PhD
University of California, Irvine
United States: Institutional Review Board