This clinical trial studies the side effects of image-guidance and online adaptation with stereotactic body radiation therapy (SBRT) for the treatment of patients with prostate adenocarcinoma that has not spread to other parts of the body (localized). Image-guided SBRT is a standard treatment for localized prostate cancer. This treatment uses imaging of the cancer within the body to define and localize the area to be treated with the radiation. Imaging can be obtained using either computed tomography (CT), magnetic resonance imaging (MRI), or a combination of the two. Typically, with SBRT, a radiation plan is developed based on the CT or MRI images obtained before treatment begins and adjustments are not made to the plan during treatment. However, anatomy can be different from day-to-day which may cause radiation to be delivered to the normal surrounding structures and possibly more side effects. During image-guided SBRT with online adaptation, the initial radiation plan is designed similarly; however, when the patient presents for radiation, the attending radiation oncologist, a dosimetrist, and a medical physicist "re-optimize" the radiation plan using the current anatomy of the day, meaning the changes in bladder and prostate size/shape are taken into account. The initial plan and the re-optimized plan are then compared, and the plan that has the optimal balance between delivering a tumor killing dose of radiation and minimizing radiation dose to normal surrounding structures is delivered. Image-guidance and online adaptation with SBRT may lower side effects and be a safer way to treat localized prostate adenocarcinoma.
Age ≥ 18
Histologically confirmed, clinically localized adenocarcinoma of the prostate
Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping
Advanced imaging studies (i.e. prostate-specific membrane antigen [PSMA] positron emission tomography [PET]/CT and fluciclovine PET/CT scan) can supplant a bone scan if performed first
Patients with neuroendocrine or small cell carcinoma of the prostate
Patients with any evidence of distant metastases except that evidence of lymphadenopathy below the level of the renal arteries can be deemed locoregional per the discretion of the investigator
Prior cryosurgery, high-intensity focused ultrasound (HIFU), brachytherapy, or other ablative treatments of the whole prostate
Prior pelvic radiotherapy
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT
CT-guided Stereotactic Body Radiation Therapy
RadiationUndergo CT-guided SBRT
Inter-fraction Adaptation of Treatment Plan
Other interventionUndergo daily plan adaptation
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
MRI-guided Stereotactic Body Radiation Therapy
RadiationUndergo MRI-guided SBRT
Survey Administration
Other interventionAncillary studies
Acute clinically relevant decline in the urinary irritative/obstructive subdomain of the Expanded Prostate Cancer Index Composite Short Form Questionnaire (EPIC-26)
A clinically relevant decrement in the EPIC-26 urinary irritative/obstructive domain is defined as greater than 14 points. Will compare the proportion of patients with a clinically relevant in genitourinary EPIC-26 urinary irritative/obstructive subdomain within 90 days of study therapy via a simple binomial test for differences in proportions. A more granular analysis will be based on the cumulative incidence method will be used to summarize risk of clinically relevant decline and Fine-Gray test will be used to compare cumulative incidences between the two arms. The analysis population includes all randomized subjects based on intent-to-treat principle. Point estimates as well as the associated 95% confidence intervals will be reported. Will also be evaluated using a multivariable analysis adjusted for variables including a simultaneous integrated boost, use of nodal radiotherapy, and use of hydrogel spacers.
Acute change in EPIC-26 scores
Will be represented by changes from baseline in the urinary incontinence, bowel, sexual function, and hormone/vitality domains. Changes will be analyzed with respect to whether they represent clinically relevant differences, defined as greater than 18, 12, and 24 points for urinary incontinence, bowel, and sexual domains, respectively. Analysis will be performed using a restricted maximum likelihood (REML)-based mixed models repeated measures (MMRM) approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom. The analysis of acute changes in the bowel domain of the EPIC-26 instrument will be stratified for use of hydrogel spacers or not.
Acute change in International Prostate Symptom Score (IPSS)
The numerical change from baseline, as well as the raw score at any given timepoint, will be extracted and reported descriptively; an absolute change of ≥ 15 points on IPSS will be considered a clinically relevant change. Analysis will be performed using a REML-based MMRM approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.
Acute change in Sexual Health Inventory for Men (SHIM) scores
The numerical change from baseline, as well as the raw score at any given timepoint, will be extracted and reported descriptively; an absolute change of ≥ 10 points on the SHIM will be considered a clinically relevant change. Analysis will be performed using a REML-based MMRM approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom.
Chronic change in EPIC-26 scores
Will be represented by changes from baseline in the urinary incontinence, bowel, sexual function, and hormone/vitality domains. Changes will be analyzed with respect to whether they represent clinically relevant differences, defined as greater than 18, 12, and 24 points for urinary incontinence, bowel, and sexual domains, respectively. Analysis will be performed using a REML-based MMRM approach. The model will include the fixed categorical effects of treatment, time, and treatment-by-time interaction, as well as the other fixed baseline covariates. An unstructured covariance structure will be used to model the within-patient errors. The Kenward-Roger approximation will be used to estimate denominator degrees of freedom. The analysis of chronic changes in the bowel domain of the EPIC-26 instrument will be stratified for use of hydrogel spacers or not.
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Jonsson Comprehensive Cancer Center
Lead sponsor
Viewray Inc.
Collaborator
National Cancer Institute (NCI)
Collaborator
