Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00956228|
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : February 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasm||Radiation: radioimmuniguided intenstiy modulated radiotherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer|
|Study Start Date :||October 2006|
|Primary Completion Date :||December 2007|
|Study Completion Date :||December 2007|
Experimental: Radioimmunoguided IMRT
All patients recieved Intensity Modulated Radiotherapy to the prostate with 75.6 Gy in 42 fractions. Additionally, they recieve a concurrent boost to the region of the prostate which enhanced on the prostascint scan to 82 Gy.
Radiation: radioimmuniguided intenstiy modulated radiotherapy
All patients recieved 75.6 Gy in 42 fractions to the prostate and the region of the prostate which enhanced on prostascint scan was simaltaneously boosted to a total dose of 82 Gy
- The primary outcome will be assessment of toxicity as well as efficacy as determined by survival rates, freedom from biochemical relapse rates, local control rates, distant failure rates.
- The main endpoint of the toxicity component is evaluating how many patients develop grade 3 or greater toxicity.
- It is expected between 0 and 9% of patients will have grade 3 or 4 toxicity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956228
|United States, Arizona|
|Scottsdale, Arizona, United States|