Evaluation of CyberKnife Stereotactic Radiotherapy in 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: NCT02016248|
Recruitment Status : Unknown
Verified August 2020 by MemorialCare Health System.
Recruitment status was: Recruiting
First Posted : December 19, 2013
Last Update Posted : August 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Stereotactic Ablative Body Radiotherapy as Monotherapy Radiation: Stereotactic Ablative Body Radiotherapy as a Boost||Not Applicable|
|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 Body Radiotherapy for Localized Prostate Cancer: Risk Stratified Monotherapy Versus Boost|
|Actual Study Start Date :||June 2012|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: Low Risk Cohort
The low risk cohort will receive:
Stereotactic Ablative Body Radiotherapy as Monotherapy on the CyberKnife System
Radiation: Stereotactic Ablative Body Radiotherapy as Monotherapy
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
Experimental: High Risk Cohort
The high risk cohort will receive:
28 treatments of external beam radiation therapy followed by Stereotactic Ablative Body Radiotherapy as a Boost on the CyberKnife System and hormonal therapy as indicated.
Radiation: Stereotactic Ablative Body Radiotherapy as a Boost
The prescribed planned tumor volume (PTV) dose of 27.5 cGy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy as a boost following 5040 cGy with external beam. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland. Hormonal therapy will given as indicated in the protocol.
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 high-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 American Society of Therapeutic Radiation and Oncology definitions, at 5 years.
- Cancer Control [ 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): NCT02016248
|Contact: Javier Zunigafirstname.lastname@example.org|
|Contact: Kristina Go-Alejoemail@example.com|
|United States, California|
|Orange Coast Memorial Medical Center||Recruiting|
|Fountain Valley, California, United States, 92708|
|Contact: Javier Zuniga 714-955-3798 firstname.lastname@example.org|
|Contact: Marielou Keuth, CRC 562-424-6109 email@example.com|
|Principal Investigator: Asif Harsolia, MD|
|Sub-Investigator: Nisar Syed, MD|
|Sub-Investigator: Ajmel Puthawala, MD|
|Sub-Investigator: Linda Chan, MD|
|Sub-Investigator: Joel Cherlow, MD|
|Sub-Investigator: Anil Sharma, PhD|
|Sub-Investigator: Junaid Pasha, MD|
|Principal Investigator:||Asif Harsolia, MD||MemorialCare|