Trial record 4 of 21 for:    cyberknife, prostate cancer

Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by MemorialCare Health System
Sponsor:
Information provided by (Responsible Party):
Asif Harsolia, MemorialCare Health System
ClinicalTrials.gov Identifier:
NCT02016248
First received: December 4, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of CyberKnife Stereotactic Body Radiotherapy for Localized Prostate Cancer: Risk Stratified Monotherapy Versus Boost

Resource links provided by NLM:


Further study details as provided by MemorialCare Health System:

Primary Outcome Measures:
  • CyberKnife toxicities in prostate cancer [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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:
  • Cancer Control [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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;


Estimated Enrollment: 167
Study Start Date: June 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02016248

Contacts
Contact: Leila Andres, CRA II (714) 378-7496 landres2@memorialcare.org

Locations
United States, California
Orange Coast Memorial Medical Center Recruiting
Fountain Valley, California, United States, 92708
Contact: Leila Andres, CRA II    714-378-7496    landres2@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

No publications provided

Responsible Party: Asif Harsolia, Radiation Oncologist, MemorialCare Health System
ClinicalTrials.gov Identifier: NCT02016248     History of Changes
Other Study ID Numbers: 065-12
Study First Received: December 4, 2012
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on July 23, 2014