Status:
ACTIVE_NOT_RECRUITING
Hypofractionated Stereotactic Body Radiation Therapy as a Boost to the Prostate
Lead Sponsor:
Boston Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 Radiatio...
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 (IMR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01508390
Start Date
June 1 2011
End Date
December 1 2027
Last Update
June 26 2025
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118