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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

Phase 2
18 Years
Not Enrolling
Prostate Cancer, Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer

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Trial Information

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.

Inclusion Criteria:

- Patient must have a histological diagnosis of adenocarcinoma of the prostate which is
measurable or evaluable Stage I or II.

- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status

- Patient must have a pre-study PSA within 28 days prior to start of therapy.

- Patients who have received prior radiotherapy are not eligible.

- Patient must have an adequate renal function

- Men of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.

- Age > 18

- Patients must be able to take oral medications

Exclusion Criteria:

- Patients with measurable metastatic diseases by a CT scan of the abdomen and pelvis
within 28 days and by a bone scan within 42 days prior to start of therapy.

- Patient must not have received chemotherapy, biologic therapy or any other
investigational drug for any reason within 28 days prior to start of therapy and must
have recovered from toxicities of prior therapy to grade 1 or less with the exception
of alopecia.

- Patients must not be treated with non-steroidal anti-androgens (flutamide,
bicalutamide, nilutamide or ketoconazole).

- Patients must not take vitamins, herbs, or micronutrient supplement within 28 days
prior to start of therapy.

- Patients may not have ongoing problems with bowel obstruction or short bowel syndrome
characterized by grade 2 or greater diarrhea or malabsorptive disorders.

- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80

- Patients should not have psychological, familial, sociological, or geographical
conditions that do not permit medical follow-up or compliance with the study

- Patients should not have any medical life-threatening complications of their

- Patients should not have a known severe and/or uncontrolled concurrent medical
disease (e.g., uncontrolled diabetes, uncontrolled chronic renal or liver disease,
active uncontrolled infection, or HIV).

- Patients should not have current, recent (within 4 weeks of the first infusion of
this study), or planned participation in an experimental drug study.

- Patients with history of myocardial infarction, cerebrovascular accident, transient
ischemic attack, or unstable angina within 6 months

- Patients with clinically significant peripheral vascular disease

- Patients with evidence of bleeding diathesis or coagulopathy

- Patients with central nervous system or brain metastases

- Patients who had major surgical procedure, open biopsy, or significant traumatic
injury within 28 days prior to Day 0, anticipation of need for major surgical
procedure during the course of the study

- Patients with minor surgical procedures, fine needle aspirations or core biopsies
within 7 days prior to Day 0

- Patients with history of abdominal fistula, gastrointestinal perforation, or
intra-abdominal abscess

- Patients with serious, non-healing wound, ulcer, or bone

- Patients who are diagnosed of any other malignancy except non-melanomatous skin
cancer in the past 5 years

- Patients receiving anticoagulation therapy (e.g. Coumadin) prior to registration

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PSA response rate (partial response (PR) + complete response (CR))

Outcome Description:

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.

Outcome Time Frame:

9 weeks

Safety Issue:


Principal Investigator

John P. Fruehauf, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine


United States: Institutional Review Board

Study ID:

UCI 07-14



Start Date:

January 2009

Completion Date:

June 2010

Related Keywords:

  • Prostate Cancer
  • Adenocarcinoma of the Prostate
  • Stage I Prostate Cancer
  • Stage II Prostate Cancer
  • prostate cancer
  • Prostatectomy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms