CT-guided Stereotactic Body Radiation Therapy and MRI-guided Stereotactic Body Radiation Therapy for Prostate Cancer, MIRAGE Study
NCT ID: NCT04384770
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
179 participants
OBSERVATIONAL
2020-05-12
2027-04-01
Brief Summary
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Detailed Description
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I. To determine whether (MRI)-guided stereotactic body radiotherapy (SBRT) improves acute physician-scored genitourinary (GU) toxicity when compared with standard computed tomography (CT)-guided SBRT for prostate cancer (PCa).
SECONDARY OBJECTIVES:
I. To determine whether there are differences in acute grade \>= 2 gastrointestinal (GI) toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale, following MRI-guided SBRT versus CT-guided SBRT.
II. To determine whether there are differences in 5-year cumulative incidences of late grade \>= 2 GU and GI physician-reported toxicity, following MRI-guided SBRT versus CT-guided SBRT.
III. To quantify the temporal changes in patient-reported quality of life (QOL) outcomes, as assessed by the Expanded Prostate Cancer Index-26 (EPIC-26), International Prostate Symptom Scores (IPSS), and Sexual Health Inventory for Men (SHIM) QOL indices, following MRI-guided SBRT.
IV. To determine whether there are differences in 5-year biochemical recurrence-free survival (BCRFS) following MRI-guided SBRT.
V. To observe the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo 5 fractions of CT-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.
GROUP II: Patients undergo 5 fractions of MRI-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 4 years, and then yearly thereafter.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group I (CT-SBRT)
Patients undergo 5 fractions of CT-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.
CT-guided Stereotactic Body Radiation Therapy
Undergo CT-guided SBRT
Questionnaire Administration
Ancillary studies
Group II (MRI-SBRT)
Patients undergo 5 fractions of MRI-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.
MRI-guided Stereotactic Body Radiation Therapy
Undergo MRI-guided SBRT
Questionnaire Administration
Ancillary studies
Interventions
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CT-guided Stereotactic Body Radiation Therapy
Undergo CT-guided SBRT
MRI-guided Stereotactic Body Radiation Therapy
Undergo MRI-guided SBRT
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No evidence of disease beyond the prostate and/or seminal vesicles (i.e., no suspicious pelvic lymph nodes or presence of metastatic disease outside the pelvis)
* Staging workup as recommended by the National Comprehensive Cancer Network (NCCN) on the basis of risk grouping:
* Low risk: No staging workup required
* Favorable intermediate-risk: CT abdomen/pelvis if Memorial Sloan Kettering Cancer Center (MSKCC) nomogram predicts \>10% probability of lymph node involvement
* Unfavorable intermediate-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts \>10% probability of lymph node involvement
* High-risk: technetium bone scan, CT abdomen/pelvis if MSKCC nomogram predicts \>10% probability of lymph node involvement
* Advanced imaging studies (i.e. prostate-specific membrane antigen positron emission tomography \[PSMA PET\] and axumin scan) can supplant a bone scan if performed first
* Ability to understand, and willingness to sign, the written informed consent
Exclusion Criteria
* Patients with any evidence of distant metastases. Note, evidence of lymphadenopathy below the level of the renal arteries can be deemed loco regional per the discretion of the investigator
* Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
* Prior pelvic radiotherapy
* History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia
* Contraindications to MRI, including:
* Electronic devices such as pacemakers, defibrillators, deep brain stimulators, cochlear implants;
* Metallic foreign body in the eye or aneurysm clips in the brain;
* Severe claustrophobia
18 Years
MALE
No
Sponsors
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Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Amar Kishan
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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References
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Kishan AU, Lamb JM, Wilhalme H, Casado M, Chong N, Zello L, Juarez JE, Jiang T, Neilsen BK, Low DA, Yang Y, Neylon J, Basehart V, Martin Ma T, Valle LF, Cao M, Steinberg ML. Magnetic Resonance Imaging Versus Computed Tomography Guidance for Stereotactic Body Radiotherapy in Prostate Cancer: 2-year Outcomes from the MIRAGE Randomized Clinical Trial. Eur Urol. 2025 Jun;87(6):622-625. doi: 10.1016/j.eururo.2024.10.026. Epub 2024 Nov 13.
Kishan AU, Ma TM, Lamb JM, Casado M, Wilhalme H, Low DA, Sheng K, Sharma S, Nickols NG, Pham J, Yang Y, Gao Y, Neylon J, Basehart V, Cao M, Steinberg ML. Magnetic Resonance Imaging-Guided vs Computed Tomography-Guided Stereotactic Body Radiotherapy for Prostate Cancer: The MIRAGE Randomized Clinical Trial. JAMA Oncol. 2023 Mar 1;9(3):365-373. doi: 10.1001/jamaoncol.2022.6558.
Ma TM, Lamb JM, Casado M, Wang X, Basehart TV, Yang Y, Low D, Sheng K, Agazaryan N, Nickols NG, Cao M, Steinberg ML, Kishan AU. Magnetic resonance imaging-guided stereotactic body radiotherapy for prostate cancer (mirage): a phase iii randomized trial. BMC Cancer. 2021 May 11;21(1):538. doi: 10.1186/s12885-021-08281-x.
Other Identifiers
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NCI-2020-02911
Identifier Type: REGISTRY
Identifier Source: secondary_id
20-000328
Identifier Type: -
Identifier Source: org_study_id