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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 : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
MemorialCare Health System

Brief Summary:
The purpose of this study is to determine the side effects and how effective CyberKnife stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with your condition and to evaluate the effect of this treatment on your quality of life over time.

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

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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 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Criteria

Inclusion Criteria:

  1. Histologically proven prostate adenocarcinoma
  2. Biopsy within 12 months of date of registration
  3. 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.
  4. 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.
  5. ECOG performance status 0-1
  6. No prior prostatectomy or cryotherapy of the prostate
  7. No prior radiotherapy to the prostate or lower pelvis
  8. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
  9. Completion of patient questionnaires
  10. Consent signed

Information from the National Library of Medicine

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


Contacts
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Contact: Javier Zuniga 714-955-3798 kgo@memorialcare.org
Contact: Kristina Go-Alejo 562-902-0811 kgo@memorialcare.org

Locations
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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         
Sponsors and Collaborators
MemorialCare Health System
Investigators
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Principal Investigator: Asif Harsolia, MD MemorialCare
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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: August 21, 2020
Last Verified: August 2020
Keywords provided by MemorialCare Health System:
CyberKnife
Prostate Cancer
Stereotactic Body Radiation
SBRT
Radiosurgery
SABR
Stereotactic Ablative Body Radiotherapy
Boost
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases