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Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer


Phase 2
18 Years
85 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer


OBJECTIVES: I. Determine the pathologic complete response rate to docetaxel in patients with
high risk stage II or III prostate cancer. II. Determine the toxicity of this treatment in
these patients. III. Correlate clinical measures of response (e.g., symptoms, physical exam,
serum PSA, and endorectal MRI) with pathologic response to this treatment in these patients.

OUTLINE: Patients receive docetaxel IV over 30 minutes weekly for 4 weeks. Treatment
continues for 2-6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 19-45 patients will be accrued for this study over 18 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Potential
candidate for radical prostatectomy Any of the following: Clinical stage T3 patients Serum
PSA at least 20 ng/mL Gleason score 8-10 Clinical T2 disease and either of the following:
MRI evidence of seminal vesicle involvement Gleason 4+3 cancer with either 5 or 6 biopsies
positive

PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: CALGB 0-1 Life expectancy: Not
specified Hematopoietic: WBC greater than 3,000/mm3 Hematocrit greater than 30% Platelet
count greater than 100,000/mm3 Hepatic: SGOT and bilirubin normal Renal: Not specified
Other: No active infection Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for prostate cancer Endocrine therapy: No prior hormonal therapy for prostate
cancer Radiotherapy: No prior radiotherapy for prostate cancer Surgery: See Disease
Characteristics No prior surgery for prostate cancer

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William Oh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000067764

NCT ID:

NCT00005096

Start Date:

December 1999

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage II prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

Name

Location
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115