Phase II Single Center Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients With an Early Rising PSA Following Radical Prostatectomy
Patients with high-risk prostate cancer have a high probability of PSA failure after radical
prostatectomy. However, more than half of these patients will remain free of PSA recurrence
for more than 10 years. To the contrary, patients with early PSA recurrence and a doubling
time less than 10 months have a mortality rate approaching 50% at 10 years despite hormone
therapy. Although androgen deprivation therapy (ADT) remains the standard treatment for
patients with early and rapidly rising PSA after prostatectomy, this treatment is not
curative on the long term for most patients. The recent demonstration of activity of
Taxotere (docetaxel) in a high proportion of patients with advanced metastatic disease has
stimulated a great interest in it use at an earlier stage of the disease. Recent studies
performed in animal models of prostate cancer suggested that the response rate of prostate
cancer cells to docetaxel-induced cell death was significantly enhanced by androgen
stimulation in AR-positive, androgen-dependent prostate cancer cells (i.e. before ADT).
Therefore, this protocol proposes to assess the response rate to primary Taxotere
chemotherapy in patients with early and rapid PSA rising after prostatectomy for high risk
disease.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the rate of partial and complete biochemical response to 8 cycles of Taxotere in patients with early (<2 years) PSA recurrence after radical prostatectomy with a PSA doubling time of <=9 months.
3 to 6 months
No
Yves Fradet, MD
Principal Investigator
Centre Hospitalier Universitaire de Quebec (CHUQ)
Canada: Health Canada
Project 5.2.08.02
NCT00714376
May 2008
July 2008
Name | Location |
---|