Status:
ACTIVE_NOT_RECRUITING
CT-guided Stereotactic Body Radiation Therapy and MRI-guided Stereotactic Body Radiation Therapy for Prostate Cancer, MIRAGE Study
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
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 standa...
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 tomograp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT04384770
Start Date
May 12 2020
End Date
April 1 2027
Last Update
December 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095