Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00193271
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

This trial will evaluate the feasibility, toxicity, and efficacy of docetaxel/estramustine, as in the adjuvant therapy of patients with high-risk prostate cancer after definitive local therapy.

Detailed Description

Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-02
• Last Update Posted: 2011-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response Rate

Secondary Outcome Measures

Name	Time	Method
Rate of recurrence
Toxicity

Trial Locations

Locations (1)

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States