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

December 9, 2011
July 25, 2013
June 2011
December 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01508390 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Radiation: CyberKnife Boost
21 Gy in 7 Gy per day, 3 fractions, Every other day
Other Name: stereotactic radiotherapy, cyberknife, radiation
Experimental: Boost
CyberKnife
Intervention: Radiation: CyberKnife Boost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact: Aria Vassilakis, RN 617-638-7537 nectaria.vassilakis@bmc.org
Contact: Ariel Hirsch, MD 617-638-7070 ariel.hirsch@bmc.org
United States
 
NCT01508390
H-29665
Yes
Boston Medical Center
Boston Medical Center
Not Provided
Principal Investigator: Ariel Hirsch, MD Boston Medical Center
Boston Medical Center
July 2013

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