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New MRI technique could better track prostate cancer without treatment
NCT ID NCT03933670
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a special MRI scan that uses a substance called hyperpolarized pyruvate to see how well it can monitor prostate cancer in patients who are not receiving treatment. About 60 men with low- to intermediate-risk prostate cancer will be scanned to measure how the cancer cells process this substance. The goal is to see if this imaging method can help doctors better decide when a biopsy or treatment is needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2018
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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: * The subject has biopsy-proven adenocarcinoma of the prostate with low to intermediate risk disease by UCSF-CAPRA scoring at study entry. * For Part 1: Patient planning to enroll or currently on active surveillance; For Part 2: Currently enrolled on active surveillance with planned fusion biopsy within 12 weeks following completion of baseline HP C-13 pyruvate/mpMRI on study. * The subject is able and willing to comply with study procedures and provide signed and dated informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Absolute neutrophil count (ANC) \>= 1000 cells/microliter (uL). * Hemoglobin \>= 9.0 gm/deciliter (dL). * Platelets \>= 75,000 cells/uL. * Estimated creatinine clearance\* \>= 50 milliliter (mL)/min by the Cockcroft Gault equation. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) or if =\< 3 x ULN if known/suspected Gilbert's * Aspartate aminotransferase (AST) =\< 1.5 x ULN. * Alanine aminotransferase (ALT) =\< 1.5 x ULN. Exclusion Criteria: * Patients without evidence of any prostate cancer on most recent prostate biopsy performed prior to study entry. * Current or prior androgen deprivation therapy including luteinizing hormone-releasing hormone (LHRH) analogue or oral anti-androgen therapy. Previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least 28 days prior to baseline C-13 HP pyruvate MRI * Prior radiation treatment of the prostate. * Prostate biopsy performed within 14 days prior to baseline C-13 HP pyruvate MRI. * Poorly controlled hypertension, with blood pressure at study entry \> 160 mm Hg systolic or \> 100 mmg Hg diastolic. Treatment with anti-hypertensives and re-screening is permitted. * Congestive heart failure with New York Heart Association (NYHA) status \>= 2.
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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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Locations
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
Contact Email: •••••@•••••
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