Is CSE-MRI as good as FLT PET for spotting active bone marrow in men with advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-site, early-phase study compares chemical shift‑encoded MRI (CSE‑MRI) with 18F‑FLT PET to see if CSE‑MRI can identify active bone marrow as accurately as FLT PET in patients with PSMA‑positive metastatic castration‑resistant prostate cancer undergoing Lu‑177 PSMA radiopharmaceutical therapy. Participants will undergo standard care imaging and therapy, with CSE‑MRI acquired alongside PET/MR scans when feasible. The primary endpoint is the mean Dice similarity coefficient between active marrow volumes derived from CSE‑MRI and FLT PET, with a target of ≥0.7 indicating clinical equivalence. Enrollment is up to 15 participants, followed for up to 14 months, with a 6‑month post‑therapy observation window. All other assessments align with standard of care except for the research MRI and PET scans.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Ability to understand and the willingness to sign a written informed consent document.
* Patients must be informed of the experimental nature of the study and its potential risks, and must sign institutional review board (IRB) approved consent form indicating such understanding.
* Individuals at least 18 years of age.
* Patients must have histologically or cytologically confirmed prostate cancer.
* Patients must be clinically deemed appropriate for standard of care Lu-177 PSMA RPT.
* Eastern Cooperative Oncology Group (ECOG) performance 0-2
* Patients must be able to comply with all study procedures, including having both the ability and willingness to lie flat for ≥ 30 minutes during imaging.

Exclusion Criteria:

* Patients receiving any concurrent therapy known to impact bone marrow (either stimulate or suppress the marrow, for example G-CSF).
* Patients treated with chemotherapy or 223Ra radiotherapy within 4 weeks.
* All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (CTCAE).
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements per treating physician discretion.

Where it's running

• University of Wisconsin Carbone Cancer Center
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Michael Lawless, PhD — UW School of Medicine and Public Health
• Study coordinator: Cancer Connect
• Email: clinicaltrials@cancer.wisc.edu
• Phone: 800-622-8922

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.