Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.

Official Title
-----------------
Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Taxotere


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following: Node positive disease post-operatively Capsule involvement Seminal Vesicles involvement Gleason score ≥ 8 >50% of core biopsies that are positive Clinical Stage T2c and T3 Pre-op PSA > 15 plus Gleason score of 7 Age greater than 18 ECOG Performance Status 0-1 Serum creatinine <= 1.5 mg/dl Granulocyte count >= 1500/m3, Hemoglobin > 8.0 g/dl, and platelet count >= 100,000/m3 Total bilirubin <= ULN AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility. Signed patient informed consent. Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter. Exclusion Criteria: Peripheral neuropathy > grade 1 History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80. Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent. Active infection within 14 days of beginning treatment Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection. Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Taxotere|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy. |  | Following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the toxicity of taxotere and hormones given adjuvantly. |  | Following treatment | 
| To measure Quality of Life on this therapy. |  | Following treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Taxotere