The goal of this clinical trial is to determine the safety of stereotactic body radiation therapy (SBRT) microboost technique in patients with low to intermediate risk prostate cancer. The main question it aims to answer is: Is microboost SBRT with whole gland de-escalation both safe and effective in managing patients with low to intermediate-risk prostate cancer while maintaining acceptable toxicity levels? All patients will receive microboost SBRT at a dose of 45 Gy delivered in 5 fractions in up to 4 MRI-defined lesions. Patients (Arm 1) with highest grade disease in the microboost target lesion in the absence of GG2-3 beyond the microboost target (only GG1 disease can be present outside of the microboost region) will receive whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions. Patients (Arm 2) with highest grade disease outside of the target lesion will receive whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions. Participants will be treated every other day over a two week period and then follow up after radiation treament for up to 5 years. Participants will be asked to complete questionnaires and provide blood and urine samples for research purposes.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Microboost SBRT at a dose of 45 Gy for 5 fractions
Whole gland de-escalation at a dose of 30 Gy delivered in 5 fractions.
Whole gland de-escalation at a dose of 35 Gy delivered in 5 fractions
Lombardi Comprehensive Cancer Center, Georgetown University
Washington D.C., District of Columbia, United States
RECRUITINGIncidence of acute grade 2 or higher genitourinary toxicity
Safety of the microboost technique will be determined based on the incidence of acute grade 2 or higher genitourinary adverse events (AEs). AEs will be assessed and graded according to the current version of the Common Terminology Criteria for Adverse Events (CTCAE) or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due to the AE, corresponding respectively to Grades 1 - 5, will be used.
Time frame: during treatment through 90 days after radiation treatment
Incidence of acute grade 2 or higher gastrointestinal (GI) toxicity
The incidence of acute grade 2 or higher gastrointestinal AEs will be assessed and graded according to the current version of the Common Terminology Criteria for Adverse Events (CTCAE) or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due to the AE, corresponding respectively to Grades 1 - 5, will be used.
Time frame: Up to 5 years
Incidence of late grade 2 or higher genitourinary (GU) or gastrointestinal (GI) toxicity
The incidence of late grade 2 or higher genitourinary or gastrointestinal AEs will be assessed and graded according to the current version of the Common Terminology Criteria for Adverse Events (CTCAE) or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due to the AE, corresponding respectively to Grades 1 - 5, will be used.
Time frame: Up to 5 years
Incidence of late grade 3 or higher genitourinary or gastrointestinal toxicity
The cumulative incidence of late grade 3 or higher genitourinary or gastrointestinal AEs will be assessed and graded according to the current version of the Common Terminology Criteria for Adverse Events (CTCAE) or severity grade when CTCAE grading does not exist. Grade 1 to 5 will be used to characterize the severity of the AE. If CTCAE grading does not exist for an AE, the severity of mild, moderate, severe, life-threatening and death due to the AE, corresponding respectively to Grades 1 - 5, will be used
Time frame: Up to 5 years
PSA (Prostate-specific antigen) nadir
PSA nadir is defined as the lowest PSA achieved at the time of follow up as determined by the treating physician. The PSA nadir will be determined by denoting the lowest value by 2- and 5-years of follow up.
Time frame: at 2 years and 5 years
Biochemical failure (BF)
Biochemical failure is defined as a PSA rise of at least 2.0 n/g/mL above the patient's PSA nadir following radiation treatment by the Phoenix definition and as determined by the treating physician.
Time frame: at 2 years and 5 years
Biochemical failure free survival (BFFS)
Biochemical failure free survival (BFFS) is defined as the length of time from radiation completion to the first documented evidence of biochemical failure of prostate cancer or death, whichever occurs first. Patients who are alive and free from biochemical failure will be censored at the date of last follow-up for BFFS.
Time frame: up to 5 years
Disease-free survival (DFS)
Defined as the length of time from radiation completion to the first evidence of biochemical or clinical recurrence of prostate cancer or death, whichever occurs first. Patients who are alive and free from disease recurrence will be censored at the date of last follow-up for DFS.
Time frame: up to 5 years
Patient-reported QoL (Quality of life) outcomes- Expanded Prostate Index Composite (EPIC)-26
Patient-reported QoL as measured by EPIC-26 questionnaire which measures health related quality of life. Scores range from 0 to 100 with higher scores indicating a better quality of life. The EPIC-26 instrument includes sub-scales like urinary function, bowel habits, and sexual function, which will be used to measure the changes in the GU (Genitourinary), GI (gastrointestinal), and sexual domains, respectively.
Time frame: up to 5 years
Patient-reported QoL outcomes- International Prostate Symptom Score (I-PSS)
The I-PSS is based on the answers to 7 questions concerning Urinary symptoms. Scores range from 0 to 35, with 0 being asymptomatic to 35 being very symptomatic.
Time frame: up to 5 years
Patient-reported QoL outcomes- International Index of Erectile Dysfunction (IIEF-5)
The IIEF-5 is a 5 question questionnaire which evaluates erectile dysfunction. Scores range from 5 to 25, 5-7 being severe erectile dysfunction and 22-25 being no erectile dysfunction.
Time frame: up to 5 years
Patient-reported QoL outcomes- Health Questionnaire (EQ-5D-5L)
EQ-5D-5L questionnaire will have participants evaluate their quality of life across 5 Dimensions including Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Index scores range from -0.59 to 1, where 1 is the best possible health state.
Time frame: up to 5 years
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