A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors
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|ClinicalTrials.gov Identifier: NCT02225262|
Recruitment Status : Active, not recruiting
First Posted : August 26, 2014
Last Update Posted : July 24, 2019
The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage prostate cancer.
The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile bulb, and bowel) from receiving damaging doses of radiation.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Cancer of the Prostate Prostate Neoplasm||Radiation: CyberKnife Radiosurgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2020|
|Experimental: CyberKnife Radiosurgery||
Radiation: CyberKnife Radiosurgery
36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
Other Name: CyberKnife
- Local control rate [ Time Frame: 5-10 years ]
- To assess the effects of hypofractionated stereotactic radiosurgery on the long-term local tumor control of prostate cancer (through documentation of the rate of biochemical Disease-Free Survival [bDFS], Phoenix and ASTRO definitions, at 5 and 10 years).
- To document the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed during the years following CyberKnife SRS for prostate cancer.
- Overall survival [ Time Frame: 5-10 years ]To measure the following in the study population: rates of local failure, distant failure, disease-free survival, disease-specific survival; quality of life (QOL) in generic and organ-specific domains.
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): NCT02225262
|United States, Illinois|
|Community Cancer Center|
|Normal, Illinois, United States, 61761|
|Principal Investigator:||Shermian Woodhouse, MD||Community Cancer Center|