CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02070952|
Recruitment Status : Unknown
Verified February 2014 by Riverside Community Hospital, California.
Recruitment status was: Recruiting
First Posted : February 25, 2014
Last Update Posted : February 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: CyberKnife Stereotactic Ablative Body Radiation Therapy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||167 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|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2018|
CyberKnife Stereotactic Ablative Body Radiation Therapy
Radiation: CyberKnife Stereotactic Ablative Body Radiation Therapy
The prescribed planned tumor volume (PTV) dose of 36.25 Gy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland.
Other Name: Accuray CyberKnife
- CyberKnife Toxicities in Prostate Cancer [ Time Frame: 5 years ]The primary safety goal of this study is to estimate, in both low-risk and intermediate-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed following CyberKnife SABR for prostate cancer. The primary efficacy goal is to document the rate of biochemical Disease-Free Survival (bDFS) using the Phoenix and ASTRO definitions, at 5 years.
- Cancer Control and Quality of Life (Composite) [ Time Frame: 5 years ]To measure the following in the study population: rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall 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): NCT02070952
|Contact: Amanda (Lori) A Arias, MBA||951-788-3115||Amanda.Arias@HCAHealthcare.com|
|United States, California|
|Riverside Community Hospital||Recruiting|
|Riverside, California, United States, 92501|
|Contact: Amanda (Lori) Arias, MBA 951-788-3115 Amanda.Arias@HCAHealthcare.com|
|Principal Investigator: Afshin Rashtian, MD|
|Principal Investigator: M. Munir Muniruzzaman, PhD|
|Sub-Investigator: Sri Gorty, MD|
|Sub-Investigator: Bouchaib Rabbani, PhD|
|Principal Investigator:||Afshin Rashtian, MD||Unaffilated|