Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer
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ClinicalTrials.gov Identifier: NCT02016248 |
Recruitment Status :
Recruiting
First Posted : December 19, 2013
Last Update Posted : November 1, 2022
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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 |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 2028 |
Estimated Study Completion Date : | June 2029 |

Arm | Intervention/treatment |
---|---|
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;

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven prostate adenocarcinoma
- Biopsy within 12 months of date of registration
- Clinical Stage I-IV, MX-M0 (AJCC 6th Edition) M-stage determined by physical exam, CT, MRI, or Bone Scan. Bone scan not required for Monotherapy Risk Group patients unless clinical findings suggest possible osseous metastases. Bone Scan and contrast CT of the abdomen should be done patients in the Boost Risk Group patients.
- Prostate volume: ≤ 100 cc (recommended not required) Determined using: volume = π/6 x length x height x width Measurement from CT or ultrasound ≤90 days prior to registration.
- ECOG performance status 0-1
- No prior prostatectomy or cryotherapy of the prostate
- No prior radiotherapy to the prostate or lower pelvis
- No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
- Completion of patient questionnaires
- Consent signed

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 Zuniga | 714-955-3798 | kgo@memorialcare.org | |
Contact: Kristina Go-Alejo | 562-902-0811 | kgo@memorialcare.org |
United States, California | |
Orange Coast Memorial Medical Center | Recruiting |
Fountain Valley, California, United States, 92708 | |
Contact: Javier Zuniga 714-955-3798 jzuniga@memorialcare.org | |
Contact: Marielou Keuth, CRC 562-424-6109 mkeuth@memorialcare.org | |
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 |
Responsible Party: | MemorialCare Health System |
ClinicalTrials.gov Identifier: | NCT02016248 |
Other Study ID Numbers: |
065-12 |
First Posted: | December 19, 2013 Key Record Dates |
Last Update Posted: | November 1, 2022 |
Last Verified: | October 2022 |
CyberKnife Prostate Cancer Stereotactic Body Radiation SBRT |
Radiosurgery SABR Stereotactic Ablative Body Radiotherapy Boost |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |