NCT02163317

Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the correlation of histopathology findings in comparison to regions of the prostate reported to be suspicious for harboring tumor burden on multiparametric MRI report/s. II. Demonstration of the dosimetric and radiobiological advantages of focal stereotactic body radiation therapy (SBRT) versus whole-gland radiation therapy. III. Evaluation of clinical outcomes in focal SBRT for localized prostate cancer. OUTLINE: Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months. After completion of study treatment, patients are followed up every 3 months for up to 24 months.

Conditions

• Adenocarcinoma of the Prostate
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-16
• Primary completion: 2021-07-28
• Completion: 2021-07-28
• First posted: 2014-06-13
• Last updated: 2024-05-10

Locations

1 site across 1 country: United States