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Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

Primary Purpose

Prostate Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CyberKnife Boost
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologically proven adenocarcinoma of the prostate

    1. Gleason score (2-10)
    2. Biopsy within six months of date of registration
    3. Patient age >18 years
  2. Clinical stage (American Joint Committee on Cancer 7th Edition)

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

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

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

    c. 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.

  3. 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
  4. Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or 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 IRB approved informed consent
  9. Patient eligible to have an MRI
  10. 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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Boost

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of local failure
Rate of local failure
Rate of distant failure
Rate of distant failure
disease-free survival
disease-free survival
Rate of disease-specific survival
Rate of disease-specific survival
Rate of overall survival
Rate of overall survival
Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
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

Full Information

First Posted
December 9, 2011
Last Updated
July 30, 2023
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01508390
Brief Title
Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2011 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boost
Arm Type
Experimental
Arm Description
CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day
Intervention Type
Radiation
Intervention Name(s)
CyberKnife Boost
Other Intervention Name(s)
stereotactic radiotherapy, cyberknife, radiation
Intervention Description
21 Gy in 7 Gy per day, 3 fractions, Every other day
Primary Outcome Measure Information:
Title
Document rate of biochemical Disease-Free Survival (bDFS)
Description
To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Rate of local failure
Description
Rate of local failure
Time Frame
5 years
Title
Rate of distant failure
Description
Rate of distant failure
Time Frame
5 years
Title
disease-free survival
Description
disease-free survival
Time Frame
5 years
Title
Rate of disease-specific survival
Description
Rate of disease-specific survival
Time Frame
5 years
Title
Rate of overall survival
Description
Rate of overall survival
Time Frame
5 years
Title
Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity
Description
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
Time Frame
5 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven adenocarcinoma of the prostate Gleason score (2-10) Biopsy within six months of date of registration Patient age >18 years Clinical stage (American Joint Committee on Cancer 7th Edition) a. T-stage determined by physical exam (Digital Rectal Exam Required) i. MRI findings (e.g. extracapsular extension) can be used to determine T-staging b. N-stage determined using abdominopelvic CT scan and/or MRI c. 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. 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 Patient is receiving, or planning to receive standard androgen deprivation therapy and initial IMRT to the prostate and positive or at-risk lymph nodes. Prostate volume greater than 20 cc and less than 100 cc Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Patient has agreed to complete questionnaires Signed IRB approved informed consent Patient eligible to have an MRI Must be able to tolerate the confinement of an MRI procedure Exclusion Criteria: No prior prostate surgery (including TURP) or prostate cancer treatment with the exception of androgen deprivation therapy No prior radiotherapy to the pelvis No implanted hardware (including metal) or other material that would prohibit appropriate treatment planning or treatment delivery No metastatic disease, with the exception of lymph node positive disease No chemotherapy for a malignancy in the last 5 years. No history of an invasive malignancy (other than basal or squamous skin cancers) in the last 5 years. No heart pacemaker, No metallic foreign body (metal sliver) in the eye, No aneurysm clip in the brain No history of a pelvic or horseshoe kidney No diagnosis of inflammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel Hirsch, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate

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