Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer
NCT02163317 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-05-10
Summary
This pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Conditions
- Adenocarcinoma of the Prostate
- Recurrent Prostate Cancer
- Stage I Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIB Prostate Cancer
Interventions
- RADIATION
-
stereotactic radiosurgery
Undergo MRI-guided focal SRS
- DEVICE
-
magnetic resonance imaging
Undergo staging MRI with contrast
- OTHER
-
quality-of-life assessment
Quality of life scores will be summarized graphically and repeated measures of variance will be conducted to test for changes in scores over time
- PROCEDURE
-
Serum Prostate Antigen Test
Test of the PSA protein in blood. The test will be run every three months for up to two years during the study.
- PROCEDURE
-
Digital Rectal Exam
Exam of rectal health. Performed every three months for up to two years throughout the study.
- BEHAVIORAL
-
Expanded Prostate Cancer Index Composite
This survey measures a patient's function and bother after prostate cancer treatment. It will be analyzed using ANOVA using data collected every 6 months for up to 2 years of the study.
Sponsors & Collaborators
-
Case Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Elisha Fredman, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-16
- Primary Completion
- 2021-07-28
- Completion
- 2021-07-28
Countries
- United States
Study Locations
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