A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
- Determine the rate of prostate-specific antigen (PSA) decline and the number of
patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising
docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in
patients with hormone-naive prostate cancer who have a persistent or rising PSA after
- Determine the tolerability of this regimen in these patients.
- Determine the progression-free survival, based on PSA progression, of these patients.
- Determine the overall survival of patients treated with chemoradiotherapy for rising
PSA after radical prostatectomy.
- Determine if the velocity of subsequent PSA failure impacts survival of these patients.
- Document subsequent therapy for patients whose previous treatment has failed and if
there is a response to that therapy.
OUTLINE: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and
undergo external-beam radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Beginning within 6 weeks after completion of chemoradiotherapy, patients receive docetaxel
IV over 1 hour on day 1 and oral prednisone twice daily on days 1-21. Treatment repeats
every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, every 4 months for 2
years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of prostate-specific antigen (PSA) decline and the number of subjects reaching a PSA nadir of zero following the intervention.
Gregory P. Swanson, MD
University of Texas Health Science Center at San Antonio
United States: Federal Government
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|