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

ConditionsProstate AdenocarcinomaProstate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperpolarized Carbon C 13 Pyruvate

    Drug

    Given IV

  • Magnetic Resonance Spectroscopic Imaging

    Procedure/Surgery

    Undergo MRSI

  • MRI Ultrasound Fusion Guided Biopsy

    Procedure/Surgery

    Undergo MR/US fusion-guided prostate biopsy

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Diagnostic (HP C-13 MRI)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Signal-to-noise ratio (SNR) of hyperpolarized lactate

Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics.

Time frame
At Baseline
2

Intra-tumoral C-pyruvate to lactate (kPL)

Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics

Time frame
At Baseline
3

Intra-tumoral C-pyruvate to glutamate (kPG)

Assessed by multi-parametric magnetic resonance imaging (mpMRI) characteristics

Time frame
At Baseline
4

Association between intra-tumoral C-pyruvate to lactate (kPL) with Gleason grade

kPL will be compared with the pathologic Gleason grade determined using tissue from an MR/US-guided fusion prostate biopsy. Measured kPL will be compared by pathologic Gleason grade using an ANOVA model. If there is an overall difference, the Newman-Keuls post hoc test will be used to determine which tissue pairs differ.

Time frame
Within 12 weeks following baseline HP C-13 pyruvate MR exam

Secondary outcomes

1

Intra-patient variability in kPL

Intra-patient variability in the kPL will be summarized by the intraclass correlation and presented with a 90% confidence interval.

Time frame
Up to 15 months
2

Intra-patient variability in kPG

Intra-patient variability in the kPG will be summarized by the intraclass correlation and presented with a 90% confidence interval.

Time frame
Up to 15 months
3

Contrast between kPL and kPG in regions of tumor

The kPL and kPG will be contrasted in regions of tumor. Determined with prostate imaging reporting and data system (PI-RADS) version 2 classification score (1 through 5)

Time frame
Up to 15 months
4

Comparison of kPL and kPG with apparent diffusion coefficient in region of tumor

The kPL and kPG will be compared with apparent diffusion coefficient in region of tumor. Determined by comparison to peak intra-tumoral apparent diffusion coefficient (ADC) value

Time frame
Up to 15 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Source ClinicalTrials.gov
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