This pilot phase II trial studies docetaxel and prednisone in treating patients with newly diagnosed stage I-II prostate cancer undergoing prostatectomy. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as prednisone, may stimulate the immune system in different ways and stop cancer cells from growing. Giving docetaxel and prednisone together may kill more tumor cells.
PRIMARY OBJECTIVES: 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. OUTLINE: 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Given IV
Given PO
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.
Time frame: 9 weeks
Rates of tumor response
Expressed with two-sided exact binomial confidence intervals.
Time frame: Up to 7 days after completion of study treatment
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
Severity will be categorized by toxicity grade according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: Up to 28 days after completion of study treatment
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