Prostate Cancer
Conditions
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
Interventions
DRUGDocetaxel
DRUGEstramustine
Sponsors
Aventis Pharmaceuticals
SCRI Development Innovations, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of recurrence | — |
| Toxicity | — |
Countries
United States
Outcome results
None listed