RECRUITING

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

Conditions

Prostate Adenocarcinoma Prostate Cancer Imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2018-07-18

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03933670

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Louise Magat

CONTACT

(415) 502-1822

Louise.Magat@ucsf.edu

Principal Investigator

Ivan de Kouchkovsky, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-18

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2018-07-18

Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

Imaging

Additional Relevant MeSH Terms

Prostate Adenocarcinoma
Prostate Cancer