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Supercharged MRI could reveal how prostate cancer reacts to radiation

NCT ID NCT06391034

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new type of MRI scan that uses a special substance called hyperpolarized pyruvate to see how prostate cancer cells change during radiation therapy. About 161 men with prostate cancer will receive the substance through an IV before their regular MRI scans. The goal is to see if this technique can detect early signs of whether the cancer is responding to treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyperpolarized 13C-pyruvate and 13C,15N-urea
What this could lead to
If successful, this imaging method could help doctors see how prostate cancer responds to radiation therapy in real time, potentially guiding more personalized treatment.
What could go wrong
This is an early-phase imaging study, not a treatment trial. The new technique may not provide clearer results than standard scans, and it involves an intravenous injection of a contrast agent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 161 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants must have biopsy-proven adenocarcinoma of the prostate, as determined by medical chart review. 2. For: 1. Part 1: Participants post-radiation therapy or currently considering EBRT. 2. Part 2A: Participants currently scheduled for or considering EBRT (no neo-adjuvant therapy planned). 3. Part 2B: Participants currently scheduled for or considering EBRT and neo-adjuvant therapy is planned. The participant has biopsy-proven adenocarcinoma of the prostate with high-risk disease, defined by the presence of at least two of following criteria: a tumor stage of T3 or T4, a Gleason score of 8 to 10, or a PSA level ≥40 ng/mL) and the participant must be planning to receive androgen deprivation therapy (ADT) with an Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist. The addition of an androgen-receptor (AR) signaling inhibitor (e.g., abiraterone, bicalutamide,apalutamide, enzalutamide or darolutamide) will be allowed. 4. Part 3: Participants who have previously received radiation treatment to the prostate and are exhibiting signs of biochemical failure, with planned fusion biopsy within 12 weeks following completion of baseline HP 13C pyruvate +/-urea mpMRI. 3. Participant is able and willing to comply with study procedures and provide signed and dated informed consent. 4. Eastern Cooperative Oncology Group (ECOG) performance status \<= 1. 5. Age \>= 18 years old at time of study entry. 6. Ability to understand and the willingness to sign a written informed consent document. 7. Demonstrates adequate organ function as defined below: 1. White Blood Cell count (WBC) \>=4000 cells/μL. 2. Hemoglobin ≥9.0 gm/dL. 3. Platelets ≥75,000 cells/μL. 4. Renal Function \> 30 Epithelial Growth Factor Receptor (eGFR). Exclusion Criteria: 1. Evidence of pelvic regional or distant metastatic disease on conventional imaging (MRI, computed tomography or whole body bone scan) or prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET) imaging. PSMA-avid lymph nodes confined to the pelvis will be allowed if \<1 centimeter (cm). 2. Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI. 3. Poorly controlled hypertension, with blood pressure at study entry \> 160 mm Hg systolic or \> 100 mm Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted. 4. Contraindication to or inability to tolerate MRI with endorectal coil (e.g. severe claustrophobia, presence of cardiac pacemaker, aneurysm clip, severe or painful hemorrhoids, rectal stricture). 5. Congestive heart failure with New York Heart Association (NYHA) status \>= 2. 6. History of clinically significant ECG abnormality, including QT prolongation, a family history of prolonged QT interval syndrome or myocardial infarction within 6 months of study entry.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Locations

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

    Contact Email: •••••@•••••

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