This clinical trial studies the safety of a computed tomography (CT) scan, with or without a magnetic resonance imaging (MRI) scan, in planning for high-dose-rate (HDR) prostate brachytherapy treatment in patients with prostate cancer. Brachytherapy is a type of radiation therapy in which radioactive implants, such as pellets, seeds, ribbons, wires, needles, balloons, or capsules, are placed in the body, directly into or near the tumor. The radiation is delivered through a flexible tube called a catheter or a larger device called an applicator. Treatment planning, or simulation, is a process used to plan radiation therapy so that the target area is precisely located and marked. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. An MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. The addition of MRI to CT for HDR prostate brachytherapy treatment planning may help patients have less urine leakage and less pain after treatment.
Men ≥ 18 years old
Histopathologically confirmed prostate cancer
No evidence of regional or distant metastases
Plan to undergo curative-intent HDR brachytherapy with or without external beam radiation therapy
Prior pelvic radiation therapy
No prior prostate MRI
Parallel
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI scan
Questionnaire Administration
Other interventionAncillary studies
Mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) Urinary Incontinence domain score
The primary analysis will be conducted using a mixed-effects model for repeated measures (MMRM) including fixed effects for treatment arm, categorical time, treatment-by-time interaction, baseline Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary incontinence score, age, comorbidity status, and the stratification factors of high-dose-rate treatment approach and rectal spacer use. EPIC-26 scores range 0-100 with higher scores meaning improved function or lower symptom bother. The primary treatment comparison will be the adjusted between-group difference at the 1-month time point derived from the treatment-by-time interaction using least-squares means, with corresponding two-sided 95% confidence intervals and p-values evaluated at a significance level of 0.05.
Mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) Urinary Incontinence domain score
Longitudinal analyses of Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary incontinence scores will be conducted using MMRM models analogous to the primary analysis, including the stratification factors as covariates. Adjusted mean scores and between-group differences at each time point will be reported with 95% confidence intervals. EPIC-26 scores range 0-100 with higher scores meaning improved function or lower symptom bother.
Mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) Urinary Irritative/Obstructive, Bowel, and Sexual domain scores
Longitudinal analyses of Expanded Prostate Cancer Index Composite-26 (EPIC-26) urinary irritative/obstructive, bowel, and sexual domain scores will be conducted using MMRM models analogous to the primary analysis, including the stratification factors as covariates. Adjusted mean scores and between-group differences at each time point will be reported with 95% confidence intervals. EPIC-26 scores range 0-100 with higher scores meaning improved function or lower symptom bother.
Cumulative incidence of grade 2 or higher genitourinary or gastrointestinal adverse events
Will be analyzed using competing-risk methods to account for death as a competing event. Cumulative incidence functions will be estimated for each treatment arm and compared using Gray's test. Fine-Gray subdistribution hazard models, including stratification factors and relevant covariates, will be used to estimate adjusted hazard ratios with 95% confidence intervals. Adverse events will be coded using the Medical Dictionary for Regulatory Activities and graded according to Common Terminology Criteria for Adverse Events version 5.0. Safety analyses will summarize the frequency, severity, and relationship of adverse events to study treatment by System Organ Class and preferred term. Each adverse event will be counted once per participant at the maximum severity grade. Serious adverse events and events leading to treatment discontinuation will be summarized separately.
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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