Study on Using Advanced MRI with Hyperpolarized 13C-Pyruvate and 13C,15N-Urea for Prostate Cancer Patients
Sponsor: Robert Bok, MD, PhD
ClinicalTrials ID:NCT06391034
This clinical trial is exploring a new type of MRI scan using special substances to better understand prostate cancer in patients who have had or are undergoing radiation therapy.
Patient Parameters
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Program Overview
The study aims to test a new MRI technique using hyperpolarized 13C-pyruvate and 13C,15N-urea to see how well it can detect changes in prostate cancer. This is especially for patients who have received or are receiving radiation therapy for prostate cancer.
Description
The study is divided into three parts:
- Part 1: Focuses on optimizing MRI imaging techniques to get the best possible images of prostate tumors compared to normal tissue.
- Part 2A: Involves patients who are planning to receive a specific type of radiation therapy called SBRT.
- Part 2B: Includes patients with high-risk prostate cancer who are scheduled for radiation therapy and hormone therapy.
- Part 3: Involves patients who have had radiation therapy and are showing signs of cancer returning. These patients will have a special MRI scan and possibly a biopsy.
Throughout the study, participants will have MRI scans and other standard care procedures to monitor their prostate cancer. The study will last for up to 24 months after the last procedure or until the participant leaves the study or passes away.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of prostate cancer.
- For Part 1: Must have had radiation therapy or be considering SBRT.
- For Part 2A: Must be scheduled for or considering SBRT without prior hormone therapy.
- For Part 2B: Must be scheduled for SBRT and hormone therapy, with high-risk prostate cancer.
- For Part 3: Must have had radiation therapy and show signs of cancer returning, with a planned biopsy.
- Must be able to follow study procedures and provide consent.
- Must have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must be 18 years or older.
- Must have adequate organ function, including specific blood cell counts and kidney function.
Exclusion Criteria
- Evidence of cancer spread beyond the pelvis on imaging tests.
- Recent prostate biopsy within 14 days before the MRI.
- Poorly controlled high blood pressure.
- Cannot tolerate MRI due to medical devices or severe claustrophobia.
- Heart failure with certain severity or recent significant heart issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Francisco | 94143 | San Francisco | California |
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