CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Riverside Community Hospital, California
Sponsor:
Information provided by (Responsible Party):
Riverside Community Hospital, California
ClinicalTrials.gov Identifier:
NCT02070952
First received: July 16, 2013
Last updated: February 21, 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 low to intermediate risk prostate cancer and to evaluate the effect of this treatment on the patients' quality of life over time.


Condition Intervention
Prostate Cancer
Radiation: CyberKnife Stereotactic Ablative Body Radiation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Riverside Community Hospital, California:

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 intermediate-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 ASTRO definitions, at 5 years.


Secondary Outcome Measures:
  • Cancer Control and Quality of Life (Composite) [ 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: July 2013
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CyberKnife
CyberKnife Stereotactic Ablative Body Radiation Therapy
Radiation: CyberKnife Stereotactic Ablative Body Radiation Therapy
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

  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

    • Gleason score 2-7 (reviewed by reference lab)
    • Biopsy within 6 months of date of registration
  2. Clinical stage (CS) T1a-T2b, N0-Nx, M0-Mx (AJCC 6th Edition)

    • T-stage and N-stage determined by physical exam and available imaging studies (ultrasound, CT, and/or MRI)
    • M-stage determined by physical exam, CT or MRI. Bone scan not required unless clinical findings suggest possible osseous metastases.
  3. PSA less than or equal to 20 ng/ml
  4. Patients belonging in one of the following risk groups:

    • Low: CS T1a-T2a and Gleason 2-6 and PSA less than or equal to 10, or
    • Intermediate: CS T2b and Gleason 2-6 and PSA less than or equal to 10, or CS T1b-T2b, and Gleason 2-6 and PSA less than or equal to 20 ng/ml, or Gleason 7 and PSA less than or equal to 10 ng/ml
  5. Prostate volume less than or equal to 100 cc

    • Determined using: volume = π/6 x length x height x width
    • Measurement from CT or ultrasound less than or equal to 90 days prior to registration
  6. Eastern Cooperative Oncology Group (ECOG performance status 0-1
  7. No prior prostatectomy or cryotherapy of the prostate
  8. No prior radiotherapy to the prostate or lower pelvis
  9. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion.
  10. Completion of patient questionnaires.
  11. Consent signed.
  12. Intermediate risk patients may be treated with 4-6 months of hormonal therapy at the discretion of the treating physician.
  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: NCT02070952

Contacts
Contact: Amanda (Lori) A Arias, MBA 951-788-3115 Amanda.Arias@HCAHealthcare.com

Locations
United States, California
Riverside Community Hospital Recruiting
Riverside, California, United States, 92501
Contact: Amanda (Lori) Arias, MBA    951-788-3115    Amanda.Arias@HCAHealthcare.com   
Principal Investigator: Afshin Rashtian, MD         
Principal Investigator: M. Munir Muniruzzaman, PhD         
Sub-Investigator: Sri Gorty, MD         
Sub-Investigator: Bouchaib Rabbani, PhD         
Sponsors and Collaborators
Riverside Community Hospital, California
Investigators
Principal Investigator: Afshin Rashtian, MD Unaffilated
  More Information

No publications provided

Responsible Party: Riverside Community Hospital, California
ClinicalTrials.gov Identifier: NCT02070952     History of Changes
Other Study ID Numbers: 1138830
Study First Received: July 16, 2013
Last Updated: February 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Riverside Community Hospital, California:
CyberKnife
Stereotactic Body Radiation Therapy
Low and Intermediate Risk Prostate Cancer

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 September 30, 2014