This clinical trial tests the effect of focal radiation therapy, high dose rate-brachytherapy (HDR-BT), in treating patients with prostate cancer. Prostate cancer is the most diagnosed cancer in men and there are many treatments available, including surgery and radiation therapy. Although surgery and radiation therapy improve survival urinary and sexual function can be significantly affected and can be long lasting. HDR-BT, a type of focal radiation therapy also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving HDR-BT may be effective in providing local control while reducing side effects in patients with prostate cancer.
Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy
Multiparametric MRI (mp-MRI) confirmed lesion(s)
No distant or locally advanced disease on standard staging exams as indicated
Bone scan and abdominopelvic computed tomography (CT)/MRI OR
Radiographic nodal or distant metastatic disease
Lesion(s) comprising > 40% of total prostate volume
Prior radiotherapy to the pelvis
Gleason score > 6 disease outside intended gross target volume (GTV)/target region(s)
Single group
Biopsy Procedure
Procedure/SurgeryUndergo tumor biopsy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
High-Dose Rate Brachytherapy
RadiationUndergo HDR-BT
Multiparametric Magnetic Resonance Imaging
Procedure/SurgeryUndergo mpMRI
PSMA PET Scan
Procedure/SurgeryUndergo PSMA PET
Questionnaire Administration
Other interventionAncillary studies
Incidence of grade 2 or greater genitourinary adverse events (AEs)
Will be defined as the percentage of patients who encounter the AE of specific grade or worse using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be calculated to indicate the toxicity level of focal radiation therapy (RT), along with the corresponding 95% Clopper-Pearson exact confidence interval.
Incidence of grade 2 or greater gastrointestinal AEs
Will be defined as the percentage of patients who encounter the AE of specific grade or worse using CTCAE v 5.0. Will be calculated to indicate the toxicity level of focal RT, along with the corresponding 95% Clopper-Pearson exact confidence interval.
Time to first grade 2 or greater adverse event
Will be analyzed as a time-to-event outcome using Kaplan-Meier (KM) methods.
Local control rate
Will be defined as lack of biopsy proven progression within target/treated region/lesion. The proportion of patients achieving local control will be estimated along with the corresponding 95% Clopper-Pearson exact confidence interval.
Prostate specific antigen (PSA) response
PSA changes over time will be assessed via repeated measures analysis of variance (ANOVA). If significant PSA changes over time are identified by repeated measures ANOVA, the individual comparisons between time points will be evaluated via Tukey's Honestly Significant Difference test as the method of accommodating multiple comparisons.
Biochemical progression free survival
Will be obtained via KM analysis to provide an overview of efficacy for focal RT.
Clinical progression free survival
Will be obtained via KM analysis to provide an overview of efficacy for focal RT.
Distant metastasis free survival
Will be obtained via KM analysis to provide an overview of efficacy for focal RT.
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