Prostate AdenocarcinomaNCT04384770
CT-guided Stereotactic Body Radiation Therapy and MRI-guided Stereotactic Body Radiation Therapy for Prostate Cancer, MIRAGE Study
An observational study of Prostate Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- CT-guided Stereotactic Body Radiation Therapy, MRI-guided Stereotactic Body Radiation Therapy and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2020to 1 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving stereotactic body radiation therapy for the treatment of prostate cancer at the University of California, Los Angeles
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Magnetic Resonance Imaging-Guided Stereotactic Body Radiotherapy for Prostate Cancer (Mirage): A Phase III Randomized Trial
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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
- Prostate Adenocarcinoma
- Being tested
- CT-guided Stereotactic Body Radiation Therapy, MRI-guided Stereotactic Body Radiation Therapy, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided Stereotactic Body Radiation TherapyRadiation
Also called Computed Tomography-Guided Stereotactic Body Radiation Therapy, CT-guided SBRT
Undergo CT-guided SBRT
MRI-guided Stereotactic Body Radiation TherapyRadiation
Also called Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy, MR-guided SBRT, MRI-guided SBRT
Undergo MRI-guided SBRT
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (CT-SBRT) | Patients undergo 5 fractions of CT-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity. Receives: 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. Receives: Radiation: MRI-guided Stereotactic Body Radiation Therapy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after stereotactic body radiation therapy (SBRT)
Secondary outcomes (5)
Incidence of acute grade >= 2 gastrointestinal (GI) toxicity
Will be assessed by the CTCAE version 4.03 scale and rates will be reported descriptively
Measured: 90 days after SBRT
Incidences of late grade >= 2 GU toxicity
Will be assessed by the CTCAE version 4.03 scale and analyzed using a cumulative incidence framework.
Measured: Up to 5 years
incidences of late grade >= 2 GI toxicity
Will be assessed by the CTCAE version 4.03 scale and analyzed using a cumulative incidence framework.
Measured: Up to 5 years
Patient-reported quality of life (QOL) outcomes
For the Expanded Prostate Cancer Index- 26 (EPIC-26) instrument, these will be represented by changes from baseline in the urinary incontinence, urinary obstruction, bowel, sexual function, and hormone/vitality domains. Changes will be analyzed with respect to whether they represent minimally important differences. For the International Prostate Symptom Score (IPSS) and Sexual Health Inventory for Men (SHIM) instruments, the numerical change from baseline, as well as the raw score at any given timepoint, will be extracted.
Measured: Up 5 years
Biochemical recurrence-free survival (BCRFS)
Will be estimated using the Kaplan-Meier method as well as descriptively (mean, standard deviation, median, first and third quartiles, minimum, maximum)., with biochemical recurrence (BCR) defined as serum PSA levels that are 2 ng/mL higher than the nadir PSA achieved after SBRT.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start12 May 2020
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amar Kishan, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384770
- Sponsor's protocol ID
- 20-000328
- Other IDs
- NCI-2020-02911
- Status last verified
- May 2026
- First submitted
- 8 May 2020
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Courtney 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.
PubMed 40482729Kishan 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.
PubMed 39537438Kishan 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.
PubMed 36633877Ma 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.
PubMed 33975579
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging-Guided Stereotactic Body Radiotherapy for Prostate Cancer (Mirage): A Phase III Randomized Trial
- ClinicalTrials.gov ID
- NCT04384770
- Acronym / sponsor ID
- 20-000328
- Conditions
- Prostate Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (CT-SBRT) | – | Radiation: CT-guided Stereotactic Body Radiation Therapy, Other: Questionnaire AdministrationPatients undergo 5 fractions of CT-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity. |
| Group II (MRI-SBRT) | – | Radiation: MRI-guided Stereotactic Body Radiation Therapy, Other: Questionnaire AdministrationPatients undergo 5 fractions of MRI-guided SBRT over 14 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving stereotactic body radiation therapy for the treatment of prostate cancer at the University of California, Los Angeles
Key inclusion criteria (9 listed)
- 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:
- Ability to understand, and willingness to sign, the written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-guided Stereotactic Body Radiation TherapyAlso: Computed Tomography-Guided Stereotactic Body Radiation Therapy, CT-guided SBRTUndergo CT-guided SBRT | Radiation | Group I (CT-SBRT) |
| MRI-guided Stereotactic Body Radiation TherapyAlso: Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy, MR-guided SBRT, MRI-guided SBRTUndergo MRI-guided SBRT | Radiation | Group II (MRI-SBRT) |
| Questionnaire AdministrationAncillary studies | Other | Group I (CT-SBRT), Group II (MRI-SBRT) |
Primary outcome
Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity
Time frame: 90 days after stereotactic body radiation therapy (SBRT)
Will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale.
5 secondary outcomes
Incidence of acute grade >= 2 gastrointestinal (GI) toxicity
Time frame: 90 days after SBRT
Incidences of late grade >= 2 GU toxicity
Time frame: Up to 5 years
incidences of late grade >= 2 GI toxicity
Time frame: Up to 5 years
Patient-reported quality of life (QOL) outcomes
Time frame: Up 5 years
Biochemical recurrence-free survival (BCRFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Derived from this study: PubMed 40482729Courtney 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.
- Derived from this study: PubMed 39537438Kishan 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.
- Derived from this study: PubMed 36633877Kishan 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.
- Derived from this study: PubMed 33975579Ma 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amar Kishan principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Adenocarcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute grade >= 2 genitourinary (GU) physician-reported toxicity (time frame: 90 days after stereotactic body radiation therapy (SBRT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04384770, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.