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

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ClinicalTrials.gov Identifier: NCT04384770
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment
Prostate Adenocarcinoma Radiation: CT-guided Stereotactic Body Radiation Therapy Radiation: MRI-guided Stereotactic Body Radiation Therapy Other: Questionnaire Administration

Detailed Description:

PRIMARY OBJECTIVE:

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging-Guided Stereotactic Body Radiotherapy for Prostate Cancer (Mirage): A Phase III Randomized Trial
Actual Study Start Date : May 12, 2020
Estimated Primary Completion Date : April 1, 2026
Estimated Study Completion Date : April 1, 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Undergo CT-guided SBRT
Other Names:
  • Computed Tomography-Guided Stereotactic Body Radiation Therapy
  • CT-guided SBRT

Other: 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.
Radiation: MRI-guided Stereotactic Body Radiation Therapy
Undergo MRI-guided SBRT
Other Names:
  • Magnetic Resonance Imaging-guided Stereotactic Body Radiation Therapy
  • MR-guided SBRT
  • MRI-guided SBRT

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of acute grade >= 2 gastrointestinal (GI) toxicity [ Time Frame: 90 days after SBRT ]
    Will be assessed by the CTCAE version 4.03 scale and rates will be reported descriptively

  2. Incidences of late grade >= 2 GU toxicity [ Time Frame: Up to 5 years ]
    Will be assessed by the CTCAE version 4.03 scale and analyzed using a cumulative incidence framework.

  3. incidences of late grade >= 2 GI toxicity [ Time Frame: Up to 5 years ]
    Will be assessed by the CTCAE version 4.03 scale and analyzed using a cumulative incidence framework.

  4. Patient-reported quality of life (QOL) outcomes [ Time Frame: Up 5 years ]
    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.

  5. Biochemical recurrence-free survival (BCRFS) [ Time Frame: 5 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384770


Contacts
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Contact: Vincent Basehart 310 267-8954 vbasehart@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Amar Kishan    310-825-6577      
Principal Investigator: Amar Kishan         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Amar Kishan UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04384770    
Other Study ID Numbers: 20-000328
NCI-2020-02911 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
20-000328 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type