Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
H-29665
- NCT ID:
NCT01508390
Conditions
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Boost | Experimental | CyberKnife Boost 21 Gy in 7 Gy per day, 3 fractions, Every other day | |
Eligibility 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 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Document rate of biochemical Disease-Free Survival (bDFS) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | To document the rate of biochemical Disease-Free Survival (bDFS), American Society for Radiation Oncology definitions |
Secondary Outcome Measures
Measure: | Rate of local failure |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Rate of local failure |
Measure: | Rate of distant failure |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Rate of distant failure |
Measure: | disease-free survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | disease-free survival |
Measure: | Rate of disease-specific survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Rate of disease-specific survival |
Measure: | Rate of overall survival |
Time Frame: | 5 years |
Safety Issue: | |
Description: | Rate of overall survival |
Measure: | Estimate the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity |
Time Frame: | 5 years |
Safety Issue: | |
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 |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Boston Medical Center |
Trial Keywords
Last Updated
September 7, 2020