Status:
COMPLETED
Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)
Lead Sponsor:
John Fiveash, MD
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
19+ years
Phase:
NA
Brief Summary
This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the enti...
Detailed Description
Objectives: Primary -Clinically assess the early toxicity of SBRT with integrated boost for clinically localized prostate cancer Secondary * Determine the technical feasibility of stereotactic bod...
Eligibility Criteria
Inclusion
- All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration
- NCCN risk category very low, low, or intermediate risk
- Combined Gleason score \<7
- PSA within three months of enrollment \< 20ng/ml
- Clinical stage T1a-c N0M0 or clinical stage T2aN0M0
- Life expectancy \> 5 years
- Risk of malignant lymph node involvement \< 15% as calculated on Partin tables
- Karnofsky performance status (KPS) \> 60
- Age \> 19 years
- Subjects given written informed consent
Exclusion
- History of inflammatory bowel disease
- Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy
- Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria.
- Platelet count \< 70
- Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
- Pre-SBRT prostate volume \> 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy).
- Risk of malignant lymph node involvement \> 15% as calculated on Partin tables.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01856855
Start Date
February 1 2013
End Date
December 1 2022
Last Update
January 12 2023
Active Locations (1)
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1
Hazelrig-Salter Radiation Oncology Center
Birmingham, Alabama, United States, 35249