Phase II Trial of Focal Radiation Therapy in Patients With Prostate Cancer
Jonsson Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. Estimate local control. II. Estimate acute/late grade 2+ genitourinary (GU)/gastrointestinal (GI) toxicity. SECONDARY OBJECTIVES: I. Prostate specific antigen (PSA) response at 6 weeks after radiation therapy (RT), every 3 months for 24 months, every 6 months to 60 months, then every 8-12 months until 5 years. II. Clinical progression free survival/biochemical progression free survival at 5 years. III. Distant metastasis free survival. IV. Development of castration-resistant disease. V. Overall survival. VI. Changes in quality of life VIa. Functional Assessment of C…
Eligibility
- Age range
- 40+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 * PSMA PET * Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment * Age ≥ 40 Exclusion Criteria: * Radiographic nodal or distant metastatic disease * Lesion(s) comprising \> 40% of total prostate volum…
Interventions
- ProcedureBiopsy Procedure
Undergo tumor biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- RadiationHigh-Dose Rate Brachytherapy
Undergo HDR-BT
- ProcedureMultiparametric Magnetic Resonance Imaging
Undergo mpMRI
- ProcedurePSMA PET Scan
Undergo PSMA PET
- OtherQuestionnaire Administration
Ancillary studies
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California