NCT00714376

Phase II Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients

Phase II Single Center Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients With an Early Rising PSA Following Radical Prostatectomy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the response to Taxotere (docetaxel) chemotherapy given as a primary treatment to patients with early and rapid PSA rising after prostatectomy for high risk disease.

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	75 mg/m2 iv every 3 weeks for 8 cycles

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-07-14
• Last updated: 2012-10-31

Locations

1 site across 1 country: Canada