Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-05-31

Brief Summary

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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.

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Detailed Description

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Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Docetaxel

Intervention Type DRUG

Estramustine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No