SBRT for Oligometastatic Castration-Refractory Prostate Cancer
Study Details
Study Description
Brief Summary
Castration-resistant prostate cancer patients with rising prostatic specific antigen (PSA) are eligible for this study. 11C-Choline PET/CT will be used to identify metastatic lesions. Patients with <=3 metastatic lesions will receive stereotactic body radiotherapy (SBRT) as definitive treatment. Blood draws will be taken to monitor the development of anti-prostate cancer immunity
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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SBRT for oligometastatic prostate cancer
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Radiation: SBRT
Other Names:
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Outcome Measures
Primary Outcome Measures
- PSA-progression free survival [1 year]
- Overall Survival [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients must be receiving standard of care SBRT as outlined in the Universal Content Management (UCM) Procedure Manual (http://mayocontent.mayo.edu/radoncology/categories/index.html)
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Age ≥ 18 years.
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Metastatic castration-refractory prostate cancer patients with ≤ 3 lesions identified on standard imaging and/or choline PET/CT within 60 days of registration
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Castrate levels of testosterone
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Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 (Appendix I).
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Life expectancy > 6 months
Exclusion Criteria:
Emergent cord compression for spinal metastases
- Severe, active co-morbidity, defined as follows:
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Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
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Transmural myocardial infarction within the last 6 months prior to registration
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Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
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Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
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Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease.
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HIV positive with Cluster Differentiation 4 (CD4) count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
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End-stage renal disease (i.e., on dialysis or dialysis has been recommended).
- Metastases located within 3 cm of the previously irradiated structures:
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Spinal cord previously irradiated to > 40 Gy
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Brachial plexus previously irradiated to > 50 Gy
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Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
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Brainstem previously irradiated to > 50 Gy
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Lung previously irradiated with prior V20Gy > 30%
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Sean S Park, MD, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 16-000785
- CA200551