This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with \<15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Device that will be used to administer radiotherapy
Radiotherapy interruptions are acceptable as long as treatments are no more than 16 days apart.
Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Patients should initiate ADT beginning no sooner than 60 days prior to start of radiation. ADT is defined as a GnRH agonist/antagonist (leuprolide, goserelin, degarelix, or relugolix). Patients treated with leuprolide, goserelin, or degarelix should also receive an androgen receptor antagonist (flutamide or bicalutamide) for 30 days from the start of GnRH agonist/antagonist or until the end of radiation, depending on institutional standard and physician preference. Agent selection is per treating physician discretion and will be administered per institutional standard and FDA-approved labeling.
Washington University School of Medicine
St Louis, Missouri, United States
Rate of acute grade ≥3 GI and GU adverse events
Time frame: From start of radiotherapy through 90 days after start of radiotherapy
Changes in patient-reported quality of life as measured by EPIC-26
-The EPIC-26 is used to assess health related quality of life among persons with prostate cancer. It contains 5 domains of urinary incontinence, urinary irritability/obstructive, bowel, sexual, and hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life.
Time frame: At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
Changes in global function as measured by EQ-5D-5L
-The EQ-5D-5L is a commonly used and reliable questionnaire used to assess patient perception of their current health state. Patients are asked about their levels of difficulty with mobility, self-care, and usual activities, and about their pain/discomfort and anxiety/depression levels on a 5-point scale where the response "I have no problems" = 1 and "I am unable/have extreme" = 5.
Time frame: At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24
Rate of acute grade ≥3 adverse events at least possibly related to radiotherapy
Time frame: From start of radiotherapy through 90 days after start of radiotherapy
Rate of acute <grade 3 GI and GU adverse events
Time frame: From start of radiotherapy through 90 days after start of radiotherapy
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