Salvage Radiation Therapy and Taxotere for PSA Failure After Radical Prostatectomy
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|ClinicalTrials.gov Identifier: NCT00480857|
Recruitment Status : Terminated (Lack of funding.)
First Posted : May 31, 2007
Results First Posted : January 16, 2015
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Docetaxel (Taxotere)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Salvage Radiation Therapy and Docetaxel (Taxotere) for Biochemical Failure After Radical Prostatectomy|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||July 2014|
Drug: Docetaxel (Taxotere)
Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
- Percentage of Patients Alive Without Progression at 4 Years [ Time Frame: 4 years ]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 ]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.
- The Percentage of Patients That Experience at Least 1 Grade 1, 2, 3 and 4 Toxicities [ Time Frame: 4 years ]
To determine the rates of toxicities among patients treated with concurrent weekly docetaxel (TAXOTERE) and salvage prostate bed radiation therapy.
G1 events are considered mild. G2 events are considered moderate G3 events are considered severe G4 events are considered life-threatening
- The Number of Patients That Experience Evidence of Local Recurrence [ Time Frame: 4 years ]The number of patients that have local disease recurrence by imaging and clinical findings.
- The Number of Patients Alive [ Time Frame: 4 years ]The number of patients alive at 4 years.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|