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Adjuvant Chemotherapy (Docetaxel and Estramustine Phosphate) for High Risk Localized Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

Adjuvant Chemotherapy (Docetaxel and Estramustine Phosphate) for High Risk Localized Prostate Cancer

Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

- Histologically confirmed adenocarcinoma of the prostate

- Clinically or surgically staged localized disease, stage I-III.

- Prior surgical resection or radiation therapy with curative intent

- No clinical evidence of residual disease

- Gleason's combined score > 7.

- Age > 18 years.

- No prior chemotherapy for prostate cancer.

- No previous androgen deprivation therapy for prostate cancer

- Able to perform activities of daily living with minimal assistance

- Adequate bone marrow, liver and kidney function

- Voluntarily provide written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

- History of prior malignancy in the past five years

- History of significant heart disease within the previous 6 months

- Cerebral vascular accident (CVA) or stroke within the previous 6 months.

- Moderate or severe peripheral neuropathy

- Previous therapy with other injectable radioisotopes.

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.

Type of Study:


Study Design:

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

Outcome Measure:

Response Rate

Principal Investigator

Anthony A. Meluch, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

May 2007

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



Tennessee Oncology, PLLC Clarksville, Tennessee  37043