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Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

Sponsor
Boston Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT01508390
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
198
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: CyberKnife Boost
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Actual Study Start Date :
Jun 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2027
Anticipated Study Completion Date :
Dec 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Boost

CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day

Radiation: CyberKnife Boost
21 Gy in 7 Gy per day, 3 fractions, Every other day
Other Names:
  • stereotactic radiotherapy, cyberknife, radiation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Document rate of biochemical Disease-Free Survival (bDFS) [5 years]

      To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions

    Secondary Outcome Measures

    1. Rate of local failure [5 years]

      Rate of local failure

    2. Rate of distant failure [5 years]

      Rate of distant failure

    3. disease-free survival [5 years]

      disease-free survival

    4. Rate of disease-specific survival [5 years]

      Rate of disease-specific survival

    5. Rate of overall survival [5 years]

      Rate of overall survival

    6. Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologically proven adenocarcinoma of the prostate

    2. Gleason score (2-10)

    3. Biopsy within six months of date of registration

    4. Patient age >18 years

    5. Clinical stage (American Joint Committee on Cancer 7th Edition)

    1. T-stage determined by physical exam (Digital Rectal Exam Required)

    2. MRI findings (e.g. extracapsular extension) can be used to determine T-staging

    3. N-stage determined using abdominopelvic CT scan and/or MRI

    4. M-stage determined by physical exam, CT and/or MRI, and bone scan (must be M0, excepting Lymph nodes)

    Please note: a SPECT bone scan including a CT of the abdomen and pelvis or an F18 Fluciclovine PET/CT fulfills protocol criteria for both the abdominopelvic CT and bone scan.

    1. Patients must belong to one of the following risk groups:

    • PSA > 20 and < 150 and/or

    • Gleason 8-10 and/or

    • clinical T3a and/or

    • Clinical N1

    OR

    • PSA 10 - 20 AND

    • Gleason 7 AND

    • Clinical T2b - T2c

    1. Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes.

    2. Prostate volume greater than 20 cc and less than 100 cc

    3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

    4. Patient has agreed to complete questionnaires

    5. Signed IRB approved informed consent

    6. Patient eligible to have an MRI

    7. Must be able to tolerate the confinement of an MRI procedure

    Exclusion Criteria:

    1. No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy

    2. No prior radiotherapy to the pelvis

    3. No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery

    4. No metastatic disease, with the exception of lymph node positive disease

    5. No chemotherapy for a malignancy in the last 5 years.

    6. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years.

    7. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain

    8. No history of a pelvic or horseshoe kidney

    9. No diagnosis of inflammatory bowel disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Medical Center Boston Massachusetts United States 02118

    Sponsors and Collaborators

    • Boston Medical Center

    Investigators

    • Principal Investigator: Ariel Hirsch, MD, Boston Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston Medical Center
    ClinicalTrials.gov Identifier:
    NCT01508390
    Other Study ID Numbers:
    • H-29665
    First Posted:
    Jan 12, 2012
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Boston Medical Center
    prostate
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Sep 8, 2021