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Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

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ClinicalTrials.gov Identifier: NCT01508390
Recruitment Status : Recruiting
First Posted : January 12, 2012
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ariel Hirsch, Boston Medical Center

Tracking Information
First Submitted Date  ICMJE December 9, 2011
First Posted Date  ICMJE January 12, 2012
Last Update Posted Date November 12, 2018
Study Start Date  ICMJE June 2011
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
Document rate of biochemical Disease-Free Survival (bDFS) [ Time Frame: 5 years ]
To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions
Original Primary Outcome Measures  ICMJE
 (submitted: January 11, 2012)
  • Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity [ Time Frame: 5 years ]
    rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity following combination ADT, EBRT and CyberKnife radiosurgery as a boost
  • Document rate of biochemical Disease-Free Survival (bDFS) [ Time Frame: 5 years ]
    To document the rate of biochemical Disease-Free Survival (bDFS), ASTRO definitions
Change History Complete list of historical versions of study NCT01508390 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2017)
  • Rate of local failure [ Time Frame: 5 years ]
    Rate of local failure
  • Rate of distant failure [ Time Frame: 5 years ]
    Rate of distant failure
  • disease-free survival [ Time Frame: 5 years ]
    disease-free survival
  • Rate of disease-specific survival [ Time Frame: 5 years ]
    Rate of disease-specific survival
  • Rate of overall survival [ Time Frame: 5 years ]
    Rate of overall survival
  • Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity [ Time Frame: 5 years ]
    rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity following combination androgen deprivation therapy, External Beam Radiation Therapy and CyberKnife radiosurgery as a boost
Original Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2012)
  • Rate of local failure [ Time Frame: 5 years ]
    Rate of local failure
  • Rate of distant failure [ Time Frame: 5 years ]
    Rate of distant failure
  • disease-free survival [ Time Frame: 5 years ]
    disease-free survival
  • Rate of disease-specific survival [ Time Frame: 5 years ]
    Rate of disease-specific survival
  • Rate of overall survival [ Time Frame: 5 years ]
    Rate of overall survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate
Official Title  ICMJE Phase II Study of Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate for Treatment of Localized, Non-Metastatic, High Risk Prostate Cancer
Brief Summary In this study, participants will have standard Androgen Deprivation Therapy and undergo standard external beam radiation therapy to the prostate and at-risk lymph nodes by Intensity Modulated Radiation Therapy. The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
Detailed Description In this study, participants will have standard androgen deprivation therapy and undergo standard radiation therapy to the prostate and at-risk lymph nodes by intensity-modulated radiation therapy (IMRT). The subsequent *boost* radiation therapy to the prostate alone will be given using the CyberKnife, rather than using the standard Intensity Modulated Radiation Therapy. This study will also see how CyberKnife affects the quality of the participant's life.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Radiation: CyberKnife Boost
21 Gy in 7 Gy per day, 3 fractions, Every other day
Other Name: stereotactic radiotherapy, cyberknife, radiation
Study Arms  ICMJE Experimental: Boost
CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day
Intervention: Radiation: CyberKnife Boost
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 11, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically proven adenocarcinoma of the prostate a. Gleason score (2-10) b. Biopsy within six months of date of registration
  2. Clinical stage (American Joint Committee on Cancer 7th Edition) a. T-stage determined by physical exam i. MRI findings (e.g. extracapsular extension) should not influence T-staging, but should be noted for later analysis b. N-stage determined using abdominopelvic CT scan c. M-stage determined by physical exam, CT and/or MRI, and bone scan
  3. Patients must belong to one of the following risk groups: a. Very High risk: Stage cT3 and Gleason 8-10 and prostate-specific antigen less than 150 b. High risk: Stage cT1-T2 and Gleason 8-10 and prostate-specific antigen less than 150 c. Moderate high risk: Stage cT3 and Gleason 7 and any prostate-specific antigen. Intermediate to high risk (a) Stage cT3 and Gleason 6 and prostate-specific antigen at least 30 e. Intermediate to high risk (b): Stage cT1-T2 and Gleason 7 and prostate-specific antigen at least 30
  4. Patient is planned to undergo standard androgen deprivation therapy and initial Intensity Modulated Radiation Therapy (IMRT) to the prostate and at-risk lymph nodes.
  5. Prostate volume greater than 20 cc and less than 100 cc
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  7. Patient has agreed to complete questionnaires
  8. Signed Institutional Review Board (IRB) approved informed consent

Exclusion Criteria:

  1. No prior prostate surgery or prostate cancer treatment
  2. No prior radiotherapy to the pelvis
  3. No implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery
  4. No chemotherapy for a malignancy in the last 5 years.
  5. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years.
  6. No history of a horseshoe kidney
  7. No diagnosis of inflammatory bowel disease
  8. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain
  9. Must be able to tolerate the confinement of an MRI procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Salli Fennessey, RN 617-638-8261 sally.fennessey@bmc.org
Contact: Ariel Hirsch, MD 617-638-7070 ariel.hirsch@bmc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01508390
Other Study ID Numbers  ICMJE H-29665
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ariel Hirsch, Boston Medical Center
Study Sponsor  ICMJE Boston Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ariel Hirsch, MD Boston Medical Center
PRS Account Boston Medical Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP