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Sponsored by: |
Centre hospitalier universitaire de Québec |
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Information provided by: | Centre hospitalier universitaire de Québec |
ClinicalTrials.gov Identifier: | NCT00714376 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Single Center Study of Docetaxel for Clinically Asymptomatic High Risk Prostate Cancer Patients With an Early Rising PSA Following Radical Prostatectomy |
Estimated Enrollment: | 30 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2012 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Denyse L'Héreault | 418-691-5050 | denyse.lhereault@crhdq.ulaval.ca |
Contact: Elisabeth Lemay | 418-691-5561 | elizabeth.lemay@crhdq.ulaval.ca |
Canada | |
Centre de recherche clinique et evaluative en oncologie, L'Hôtel-Dieu de Québec-CHUQ | Recruiting |
Quebec, Canada | |
Contact: Denyse L'Héreault 418-691-5050 denyse.lhereault@crhdq.ulaval.ca | |
Principal Investigator: Yves Fradet, MD |
Principal Investigator: | Yves Fradet, MD | Centre Hospitalier Universitaire de Quebec (CHUQ) |
Principal Investigator: | Pierre Ouellet, MD | Centre hospitalier universitaire de Québec |
Responsible Party: | Centre Hospitalier Universitaire de Québec ( Yves Fradet ) |
Study ID Numbers: | Project 5.2.08.02 |
Study First Received: | July 10, 2008 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00714376 |
Health Authority: | Canada: Health Canada |
Prostate cancer High-risk prostate cancer Radical prostatectomy |
Early rising PSA Taxotere Docetaxel |
Docetaxel Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |