Neoadjuvant Docetaxel on Newly Diagnosed Intermediate and High Grade Cancer of the Prostate (2007-5904)
|Prostate Cancer Adenocarcinoma of the Prostate Stage I Prostate Cancer Stage II Prostate Cancer||Drug: Docetaxel Drug: Prednisone||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- PSA response rate (partial response (PR) + complete response (CR)) [ Time Frame: 9 weeks ]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.
- Rates of tumor response [ Time Frame: Up to 7 days after completion of study treatment ]Expressed with two-sided exact binomial confidence intervals.
- The rate of negative surgical margin [ Time Frame: Up to 7 days after completion of study treatment ]
- The proportion of patients with pathological down-staging defined as evidence of decreased pathological stage or Gleason score when compared with pretreatment pathological stage [ Time Frame: Up to 7 days after completion of study treatment ]
- Adverse events defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment [ Time Frame: Up to 28 days after completion of study treatment ]Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|Study Start Date:||January 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Experimental: Treatment (docetaxel and prednisone)
Patients receive docetaxel IV over 60 minutes on days 1 and 2 and prednisone PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: Prednisone
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598858
|Principal Investigator:||John P. Fruehauf, MD, PhD||University of California, Irvine|