Status:
RECRUITING
Using MRI to Identify Areas to Receive Lower Doses of Radiation Treatment in Men With Prostate Cancerdose Mapping to Preserve Quality of Life
Lead Sponsor:
University of Chicago
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The purpose of this research is to gather information on the safety and effectiveness of using an imaging technique called magnetic resonance imaging (MRI) to decrease radiation dose to the uninvolved...
Eligibility Criteria
Inclusion
- Adult (≥ 18 years old) male patients with an ECOG Performance Status 0-2
- Histologically-confirmed, MRI-visible prostate adenocarcinoma with NCCN intermediate- or high-risk disease1 without extra-pelvic metastasis.
Exclusion
- Distant metastases
- 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.
Key Trial Info
Start Date :
January 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06171269
Start Date
January 5 2024
End Date
October 20 2028
Last Update
January 8 2025
Active Locations (1)
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1
University of Chicago Medicine Comprehensive Cancer Center
Chicago, Illinois, United States, 60637