Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy
The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for your stage of prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer is radiation therapy alone, possibly in combination with hormonal therapy. In this study, all patients will receive chemotherapy and radiation therapy. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments. This study is to determine the effects, good and/or bad, of adding chemotherapy to radiation therapy as "salvage" treatment for recurrent prostate cancer after surgery.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure After Radical Prostatectomy|
- Percentage of Patients Alive Without Progression at 4 Years [ Time Frame: 4 years ] [ Designated as safety issue: No ]The primary objective is to assess the 4-year progression free proportion of patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy among patients with biochemical recurrence after radical prostatectomy.
- Number of Patients That Achieve a Post-radiotherapy PSA Nadir of 0.1 ng/mL or Less [ Time Frame: 4 years ] [ Designated as safety issue: No ]To determine the rates of complete biochemical response (as defined by achievement of a post-radiotherapy PSA nadir of 0.1 ng/mL or less) after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.
- To Determine the Rates of Acute and Late Toxicities [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]To determine the rates of acute and late toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.
- To Determine the Rates of Local Recurrence-free Survival, Distant Metastasis- Free Survival, Disease-specific Survival and Overall Survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]To determine the rates of local recurrence-free survival, distant metastasis-free survival, disease-specific survival and overall survival after concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.
|Study Start Date:||March 2007|
|Study Completion Date:||July 2014|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Drug: Docetaxel (Taxotere)
Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
There is no treatment proven more effective for clinically localized prostate cancer than radical prostatectomy. Nonetheless, approximately 30,000 men annually in the U.S. develop recurrence of their prostate cancer after prostatectomy. Radiation therapy is commonly utilized as attempted salvage treatment for patients who develop a rising PSA (Prostate Specific Antigen) after prostatectomy and have no evidence of metastatic disease. This study is designed to determine whether concurrent chemotherapy, weekly docetaxel, and daily radiation therapy will result in improved disease control and survival rates over those obtained with radiotherapy alone in the treatment of men with biochemical recurrence after radical prostatectomy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480857
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-5010|
|Principal Investigator:||Daniel A. Hamstra, M.D., Ph.D.||University of Michigan|