Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance

Description

This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.

Conditions

Prostate Adenocarcinoma, Prostate Cancer

Study Overview

Study Details

Study overview

This phase II trial studies the side how well hyperpolarized carbon C 13 pyruvate (HP C-13 pyruvate) magnetic resonance imaging (MRI) works in monitoring patients with prostate cancer on active surveillance who have not received treatment. Diagnostic procedures, such as MRI, may help visualize HP C-13 pyruvate uptake and breakdown in tumor cells.

A Phase 2 Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) in Patients With Prostate Cancer on Active Surveillance

Hyperpolarized Pyruvate (13C) MR Imaging in Monitoring Patients With Prostate Cancer on Active Surveillance

Condition
Prostate Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Ivan de Kouchkovsky, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

2025-10-31