Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy.
- Determine the complete response rate in patients with biochemically-relapsed,
hormone-sensitive prostate cancer treated with docetaxel.
- Determine the time to PSA recurrence in patients receiving this treatment.
- Determine the time to metastatic disease in patients receiving this treatment.
- Determine the time to androgen independent state in patients receiving this treatment.
- Determine the time to death from any cause in patients receiving this treatment.
OUTLINE: This is an open label study.
Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for
4-6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study therapy, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml
Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.
While receiving study treatment (approximately 6 months)
Tomasz M. Beer, MD
OHSU Knight Cancer Institute
United States: Federal Government
|University Cancer Center at University of Washington Medical Center||Seattle, Washington 98195|
|OHSU Knight Cancer Institute||Portland, Oregon 97239|