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

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.

Sex

Male

Minimum age

18 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

• DERIVEDCourtney PT, Dong H, Lao Y, Pham J, Lauria M, Chu FI, Krupien AJ, Valle LF, Low DA, Lamb J, Steinberg ML, Qi XS, Cao M, Kishan AU. Dosimetric Comparison of Magnetic Resonance Imaging Guided Versus Reduced Margin Computed Tomography Guided Stereotactic Body Radiation Therapy for Localized Prostate Cancer: Post Hoc Analysis of a Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2026 May 1;125(1):266-274. doi: 10.1016/j.ijrobp.2025.05.066. Epub 2025 Jun 5. PMID 40482729
• DERIVEDKishan 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
• DERIVEDKishan 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
• DERIVEDMa 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