Adjuvant Docetaxel and Estramustine Phosphate for High Risk Localized Prostate Cancer

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Docetaxel

Drug: Estramustine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193271

IIT16165

SCRI GU 19

Details and patient eligibility

About

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.

Full description

Upon determination of eligibility, patients will receive:

Docetaxel + Estramustine

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.