Using MRI to Identify Areas to Receive Lower Doses of Radiation Treatment in Men With Prostate Cancerdose Mapping to Preserve Quality of Life
NCT ID: NCT06171269
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-01-05
2028-10-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiation therapy
Participants will receive MRI scan before starting Radiation treatment. The results of this scan will be used to identify areas of the prostate to receive low doses of radiation (areas that show no cancer cells seen by the MRI scan).
Radiation
Radiation to the prostate gland will be given daily (Mon-Friday) for 4 weeks.
MRI
The study doctor will use an MRI scan to take pictures of the prostate gland. These images of the prostate gland will let the study doctor know which areas of the prostate contain cancer cells that need to be targeted with higher doses of radiation and which uninvolved areas to target with lower doses of radiation.
Androgen Deprivation Therapy
Treatment of treating physician choice will be given for 6-24 months.
Interventions
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Radiation
Radiation to the prostate gland will be given daily (Mon-Friday) for 4 weeks.
MRI
The study doctor will use an MRI scan to take pictures of the prostate gland. These images of the prostate gland will let the study doctor know which areas of the prostate contain cancer cells that need to be targeted with higher doses of radiation and which uninvolved areas to target with lower doses of radiation.
Androgen Deprivation Therapy
Treatment of treating physician choice will be given for 6-24 months.
Eligibility Criteria
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Inclusion Criteria
* Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease1 without extra-pelvic metastasis.
Exclusion Criteria
* Prior active treatment for prostate cancer including radical prostatectomy, high-intensity focused ultrasound (HIFU), cryosurgery, ADT, or cytotoxic chemotherapy for treatment of prostate cancer. Patients with prostate cancer on active surveillance prior to the study are not excluded if they have not received active treatment.
* Prior pelvic radiotherapy including brachytherapy.
* Additional active concurrent malignancies (except localized cutaneous squamous or basal cell carcinomas).
* Comorbid conditions that, in the opinion of the treating radiation oncologist, preclude the patient from safely receiving the protocol-specified treatment including RT and/or ADT.
* Patients with contraindications to MRI including patients with ferromagnetic materials in their body (e.g. bioimplants, surgical hardware, shrapnel), patients who are unable to receive contrast due to history of allergy or impaired renal function (glomerular filtration rate \< 30 mil/min), and patients unable to tolerate MRI for other reasons (e.g. significant claustrophobia).
* Patients for whom hydrogel or hyaluronic acid spacer will be placed.
* Patients incapable of giving informed consent.
* Patients who are unable to adhere to the experimental protocols for any reason.
18 Years
MALE
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Stanley Liauw
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB23-1023
Identifier Type: -
Identifier Source: org_study_id
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