Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

This study is currently recruiting participants.
Verified July 2013 by Boston Medical Center
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01508390
First received: December 9, 2011
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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 IMRT. This study will also see how CyberKnife affects the quality of the participant's life.


Condition Intervention Phase
Prostate Cancer
Radiation: CyberKnife Boost
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    To document the rate of biochemical Disease-Free Survival (bDFS), ASTRO definitions


Secondary Outcome Measures:
  • Rate of local failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Rate of local failure

  • Rate of distant failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Rate of distant failure

  • disease-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    disease-free survival

  • Rate of disease-specific survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Rate of disease-specific survival

  • Rate of overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Rate of overall survival


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boost
CyberKnife
Radiation: CyberKnife Boost
21 Gy in 7 Gy per day, 3 fractions, Every other day
Other Name: stereotactic radiotherapy, cyberknife, radiation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 [AJCC] 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: cT3 and Gleason 8-10 and PSA less than 150 b. High risk: cT1-T2 and Gleason 8-10 and PSA less than 150 c. Moderate high risk: cT3 and Gleason 7 and any PSA d. Intermediate to high risk (a) cT3 and Gleason 6 and PSA at least 30 e. Intermediate to high risk (b): cT1-T2 and Gleason 7 and PSA 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508390

Contacts
Contact: Aria Vassilakis, RN 617-638-7537 nectaria.vassilakis@bmc.org
Contact: Ariel Hirsch, MD 617-638-7070 ariel.hirsch@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Aria Vassilakis, RN    617-638-7537    nectaria.vassilakis@bmc.org   
Principal Investigator: Ariel Hirsch, MD         
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Ariel Hirsch, MD Boston Medical Center
  More Information

No publications provided

Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT01508390     History of Changes
Other Study ID Numbers: H-29665
Study First Received: December 9, 2011
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
prostate

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 April 15, 2014