Finding studies
Finding studies
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Lead
OHSU Knight Cancer Institute
OBJECTIVES: Primary * Determine the maximum tolerated dose (MTD) of neoadjuvant radiotherapy and docetaxel in patients who are undergoing prostatectomy for high-risk localized prostate cancer. * Determine the pathologic response rate in patients treated at the phase II dose. Secondary * Determine the prostate-specific antigen (PSA) short-term response rate in patients treated with this regimen. * Determine the long-term safety of this regimen prior to radical prostatectomy in these patients. * Determine the clinical response to this regimen by urologic examination of these patients. * Determine the surgical margin status at the time of prostatectomy in patients treated with this regimen. * Determine the effect of this regimen, in terms of Health-Related Quality of Life by Expanded Prostate Cancer Index Composite (EPIC) and urinary symptom scores by the American Urological Association's measures, in these patients. * Determine the clinical progression-free rate in patients treated with this regimen. * Identify pretreatment predictors of response in these patients by examining tissue biomarkers in preserved pretreatment biopsy specimens. * Determine the biologic impact of this regimen on these patients by examining the prostatectomy specimens. * Collect frozen serum for future analysis of correlative biomarkers. * Compare the RNA content (gene expression profile) of pre- and post-treatment tumor specimens in order to describe the molecular impact of this regimen on prostate cancer. OUTLINE: This is a phase I, dose-escalation study of docetaxel followed by a phase II study. All patients undergo a biopsy of the prostate to gather research-only specimens prior to the beginning of treatment. * Phase I: Patients undergo radiotherapy once daily, 5 days a week, for 5 weeks. Patients also receive docetaxel IV on days 1, 8, 15, 22, and 29. Treatment continues in the absence of disease progression or unacceptable toxicity. Approximately 4-6 weeks after completion of chemoradiotherapy, patients undergo a radical prostatectomy. Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity. At least 6 patients are treated at the MTD. * Phase II: Patients undergo radiotherapy as in phase I. Patients also receive docetaxel at the MTD determined in phase I and then undergo prostatectomy as in phase I. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.
Age
18–100
Sex
MALE
Healthy volunteers
Not accepted
