This phase II/III trial studies how well magnetic resonance imaging (MRI)-mapped dose-escalated salvage radiotherapy works after surgery in treating patients with prostate cancer. A very focused treatment of high dose boost of radiation delivered to the regions of the prostate bed indicated to have a tumor based on MRI scans may be more effective and create less side effects than standard radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01411345.
PRIMARY OBJECTIVE:
I. To determine the effect of radiation boost to the imaging detected lesions on initial complete biochemical response.
SECONDARY OBJECTIVES:
I. To determine the impact of salvage radiation therapy (SRT) boost to the MRI-identified lesion on toxicity, health-related quality of life (HRQOL), prostate cancer-specific anxiety, and prostate cancer-specific quality of life (QOL).
II. To evaluate biochemical and clinical failure, failure-free survival, and overall survival.
III. To determine the distribution and degree of expression of tissue biomarkers by ultrasound (US)-directed biopsies for patients who choose to undergo the optional biopsies.
IV. Compare positron emission tomography (PET) and MRI detected lesions.
V. To determine the incidence and relationship of circulating deoxyribonucleic acid (DNA) and tumor cells to tissue biomarkers and initial complete biochemical response.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard SRT (SSRT) in the form of intensity-modulated radiation therapy 5 times per week over 7-8 weeks in the absence of disease progression or unacceptable toxicity. (CLOSED)
ARM II: Patients undergo mapped tumor salvage radiation therapy (MTSRT) 5 times per week over 7-8 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks, 3 months, 9 months, and every 6 months for 5.25 years.
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorMatthew Charles Abramowitz
