This clinical trial studies the side effects and how well magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. MR-guided SBRT uses magnetic resonance imaging (MRI) to define and localize the area to be treated, which may help provide more accurate delivery of SBRT and lower side effects. MR-guided SBRT may be safe, tolerable, and/or effective in treating patients with prostate cancer.
Documented informed consent of the participant and/or Legally Authorized Representative
Assent, when appropriate, will be obtained and documented for adults lacking capacity per institutional guidelines
Age: ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) ≤ 2
Chemotherapy, biological therapy, immunotherapy within 21 days or five half-lives (whichever is shorter) prior to day 1 of protocol therapy
Current or planned androgen deprivation therapy (ADT), including leutenizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, antiandrogens, or prior bilateral orchiectomy. Prior 5-alpha reductase inhibitor use is permitted if discontinued ≥ 90 days prior to baseline PSA assessment or if the corrected PSA value (measured PSA × 2) meets protocol risk group eligibility criteria (≤ 20 ng/mL)
Prior focal therapy for prostate cancer, including but not limited to high intensity focused ultrasound (HIFU), cryotherapy, irreversible electroporation (IRE), laser ablation, or photodynamic therapy
Prior pelvic radiation therapy
Single group
Biopsy Procedure
Procedure/SurgeryUndergo biopsy
Computed Tomography
Procedure/SurgeryUndergo CT
Electronic Health Record Review
Other interventionAncillary studies
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
MRI-guided Stereotactic Body Radiation Therapy
RadiationUndergo MR-guided SBRT
Questionnaire Administration
Other interventionAncillary studies
Incidence of grade ≥ 3 treatment-related toxicity
Safety defined as patients completing focal magnetic resonance (MR)-guided stereotactic body radiation therapy (SBRT) without grade ≥ 3 treatment-related toxicity (per Common Terminology Criteria for Adverse Events \[CTCAE\] version \[v\] 6.0) occurring within 90 days post treatment. Will be estimated along with its associated 95% Clopper Pearson exact binomial confidence interval (CI).
Incidence of all grades and grade ≥ 2 toxicities at least possibly related to study therapy
Tolerability of focal MR-Guided SBRT, defined as rate of all-grades and grade ≥ 2 toxicities at least possibly related to study therapy as measured by CTCAE v6.0. Will be summarized descriptively. Toxicities will be further categorized by timing (acute: ≤ 90 days post SBRT; late: 91 days to 1 year post SBRT) and by organ system, specifically genitourinary and gastrointestinal.
Change in urinary, bowel, and sexual function
Measured using the Expanded Prostate Cancer Index Composite-26 questionnaire. Will be summarized descriptively at each scheduled assessment time point among participants with available data.
Change in prostate symptoms
Measured using the International Prostate Symptom Score questionnaire. Will be summarized descriptively at each scheduled assessment time point among participants with available data.
Change in sexual health
Measured using the Sexual Health Inventory for Men. Will be summarized descriptively at each scheduled assessment time point among participants with available data.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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