About this trial
To look at the safety and effectiveness of stereotactic body radiation therapy (SBRT) in treating advanced or high-risk prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate within one year of study entry. Evaluation can happen outside of MD Anderson as long as histological confirmation takes place at MD Anderson.
cT1c-T3a by digital exam or imaging (AJCC 8th Ed.). No cT3b-4 by digital exam or imaging (AJCC 8th Ed.)
Gleason Grade Group 2-5 (Gleason 7, 8, 9, 10).
If Gleason Grade 2, must meet definition of unfavorable intermediate risk (at least one of the following: cT2b, and/or ≥ 50% biopsy cores positive, and/or PSA >10 ng/mL prior to starting androgen deprivation therapy (ADT).
Disqualifiers
Diagnosis of active scleroderma, lupus, or other rheumatologic disease which in the opinion of the treating radiation oncologist precludes safe RT.
Prior prostatectomy, cryosurgery, or HIFU for adenocarcinoma of the prostate
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields
Distant metastatic disease on conventional imaging, which by the discretion of the treating physician cannot be treated definitively.
Trial design
Single group
Treatments tested in this trial
Stereotactic Body Radiation Therapy
DeviceUndergo Radiation Therapy
Treatment groups
Trial outcomes
Primary outcomes
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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