CT-guided Stereotactic Body Radiation Therapy and MRI-guided Stereotactic Body Radiation Therapy for Prostate Cancer, MIRAGE Study

NCT04384770 | Active Not Recruiting

• 2 other identifiers: 20-000328NCI-2020-02911
• Study Type: observational
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

This phase III trial studies compares CT-guided stereotactic body radiation therapy and MRI-guided stereotactic body radiation therapy (SBRT) in treating prostate cancer. Image-guided SBRT is a standard treatment for prostate cancer, which combines imaging of the cancer within the body with the delivery of therapeutic radiation doses produced on a linear accelerator machine. Imaging modalities for image-guided SBRT can be either computed tomography imaging (CT), magnetic resonance imaging (MRI), or a combination of the two. This research is being done to help determine whether there are benefits to MRI-guidance over CT-guidance in patients who are receiving the same radiation dose by SBRT to treat prostate cancer.

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity

  Will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale.

  90 days after stereotactic body radiation therapy (SBRT)

Secondary Outcomes (5)

• Incidence of acute grade >= 2 gastrointestinal (GI) toxicity

  90 days after SBRT

• Incidences of late grade >= 2 GU toxicity

  Up to 5 years

• incidences of late grade >= 2 GI toxicity

  Up to 5 years

• Patient-reported quality of life (QOL) outcomes

  Up 5 years

• Biochemical recurrence-free survival (BCRFS)

  5 years

Study Arms (2)

Group I (CT-SBRT)

Patients undergo 5 fractions of CT-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.

Radiation: CT-guided Stereotactic Body Radiation Therapy; Other: Questionnaire Administration

Group II (MRI-SBRT)

Patients undergo 5 fractions of MRI-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity.

Radiation: MRI-guided Stereotactic Body Radiation Therapy; Other: Questionnaire Administration

Interventions

CT-guided Stereotactic Body Radiation Therapy RADIATION

Undergo CT-guided SBRT

Also known as: Computed Tomography-Guided Stereotactic Body Radiation Therapy, CT-guided SBRT

Group I (CT-SBRT)

MRI-guided Stereotactic Body Radiation Therapy RADIATION

Undergo MRI-guided SBRT

Also known as: Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy, MR-guided SBRT, MRI-guided SBRT

Group II (MRI-SBRT)

Questionnaire Administration OTHER

Ancillary studies

Group I (CT-SBRT); Group II (MRI-SBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving stereotactic body radiation therapy for the treatment of prostate cancer at the University of California, Los Angeles

You may qualify if:

• Histologically confirmed, clinical localized adenocarcinoma of the prostate
• 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

You may not qualify if:

• Patients with neuroendocrine or small cell carcinoma of the prostate
• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (3)

• 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.

  PMID: 39537438 DERIVED

• 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.

  PMID: 36633877 DERIVED

• 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.

  PMID: 33975579 DERIVED

Study Officials

• Amar Kishan

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 12, 2020
• Study Start: May 12, 2020
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)