Neoadjuvant docetaxel followed by radical prostatectomy in patients with high-risk localized prostate cancer: a preliminary report.

Journal Article (Clinical Trial;Journal Article)

Effective treatment options for high-risk localized prostate cancer are limited. Patients at high risk for recurrence include those with biopsy Gleason scores of 8 to 10, prostate specific antigen (PSA) levels > 20 ng/mL, and clinical stage T3 disease. Docetaxel chemotherapy is active in hormone-refractory prostate cancer, either combined with estramustine or used as a single agent. To determine if systemic therapy can improve the outcome of radical prostatectomy in men with high-risk localized prostate cancer, we are undertaking a pilot phase II clinical trial of weekly docetaxel at 36 mg/m(2) for up to 6 months, followed by surgery. Patients are monitored with weekly visits, monthly digital rectal examinations, PSA measurement, and testosterone tests, and endorectal magnetic resonance imaging done at baseline, after two cycles, and again after six cycles. To date, 15 patients have been enrolled, and 70 cycles of chemotherapy have been administered. Toxicity has been mostly grade 1 in intensity, and fatigue has been the most common grade 2 toxicity reported. The primary endpoint of the trial is measurement of pathologic complete response rate, for which data are not yet available. Recruitment to the trial is ongoing.

Full Text

Duke Authors

Cited Authors

  • Oh, WK; George, DJ; Kaufman, DS; Moss, K; Smith, MR; Richie, JP; Kantoff, PW

Published Date

  • August 2001

Published In

Volume / Issue

  • 28 / 4 Suppl 15

Start / End Page

  • 40 - 44

PubMed ID

  • 11685727

International Standard Serial Number (ISSN)

  • 0093-7754

Digital Object Identifier (DOI)

  • 10.1016/s0093-7754(01)90153-8


  • eng

Conference Location

  • United States