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Trial record 19 of 1081 for:    prostate cancer AND radiation

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02016248
Recruitment Status : Recruiting
First Posted : December 19, 2013
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Prostate Cancer Radiation: Stereotactic Ablative Body Radiotherapy as Monotherapy Radiation: Stereotactic Ablative Body Radiotherapy as a Boost

  Show Detailed Description

Study Design

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
Study Start Date : June 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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;


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Contacts and Locations

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
Contact: Julie Rothermich (714) 378-7496 jrothermich@memorialcare.org

Locations
United States, California
Orange Coast Memorial Medical Center Recruiting
Fountain Valley, California, United States, 92708
Contact: Julie Rothermich    714-378-7496    jrothermich@memorialcare.org   
Principal Investigator: Asif Harsolia, MD         
Principal Investigator: Munir Muniruzzamon, PhD         
Sub-Investigator: Nisar Syed, MD         
Sub-Investigator: Ajmel Puthawala, MD         
Sub-Investigator: Linda Chan, MD         
Sub-Investigator: Steve Damore, MD         
Sub-Investigator: Joel Cherlow, MD         
Sub-Investigator: Anil Sharma, PhD         
Sponsors and Collaborators
MemorialCare Health System
Investigators
Principal Investigator: Asif Harsolia, MD MemorialCare
Principal Investigator: Munir Muniruzzamon, PhD MemorialCare
More Information

Responsible Party: Asif Harsolia, Radiation Oncologist, MemorialCare Health System
ClinicalTrials.gov Identifier: NCT02016248     History of Changes
Other Study ID Numbers: 065-12
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015

Keywords provided by Asif Harsolia, MemorialCare Health System:
CyberKnife
Prostate Cancer
Stereotactic Body Radiation
SBRT
Radiosurgery
SABR
Stereotactic Ablative Body Radiotherapy
Boost

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases