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Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer

ConditionsProstate CancerLocalized Prostate Carcinoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorIvan de Kouchkovsky, MD

About this trial

This pilot clinical trial studies how well magnetic resonance spectroscopic imaging (MRSI) with hyperpolarized carbon 13 (13C) pyruvate alone or in combination with 13C 15N2 Urea works in finding prostate cancer that exhibits poorly differentiated or undifferentiated cells (high-grade) and that is restricted to the site of origin, without evidence of spread (localized) in patients undergoing radical prostatectomy. Diagnostic procedures, such as MRSI with hyperpolarized carbon (13C) pyruvate, may aid in the diagnosis of prostate cancer and in discriminating high-grade from low-grade prostate cancer and benign adjacent prostate tissue

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Biopsy-proven adenocarcinoma of the prostate. Biopsy may be performed outside of University of California, San Francisco (UCSF), if detailed results of sextant biopsy are available. For Cohort A only, a minimum of 20 participants out of a planned enrollment of 50 patients must have high-risk disease as defined by primary Gleason score of 4 or 5 on prior prostate biopsy.

Cohort A only: Planned radical prostatectomy at UCSF within 12 weeks following protocol MRI/MRSI.

Cohort B only: HIFU focal therapy completed within 18 months of protocol MRI/MRSI, and planned systematic and MR-guided biopsy at UCSF within 12 weeks following protocol MRI/MRSI.

The participant is able and willing to comply with study procedures and provide signed and dated informed consent

Disqualifiers

Participants who because of age less than 18 years old, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.

Participants unwilling or unable to undergo MR imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.

Participants who cannot tolerate or have contra-indications to endorectal coil insertion; for example, participants with a prior abdominoperineal resection of the rectum or latex allergy.

Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperpolarized 13C-Pyruvate

    Drug

    Given IV

  • Hyperpolarized 13C,15N2-urea

    Drug

    Given IV

  • Magnetic Resonance Spectroscopic Imaging

    Procedure/Surgery

    Undergo MRSI

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cohort A: Pre-surgical Prostate Cancer patientsExperimental treatment 3 interventions
Group B: Cohort B: Post-HIFU ParticipantsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio by pathological grade (Cohort A)

Means and standard deviations for lactate area under curve will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)).

Time frame
Baseline, 1 day
2

Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio (Cohort B)

Means and standard deviations for lactate area under curve will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.

Time frame
Baseline, 1 day
3

Mean lactate area under curve (AUC) by pathological grade (Cohort A)

Means and standard deviations for lactate area under curve will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)). A One-way ANOVA model will be used to compare lactate area under curve by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)).

Time frame
Baseline, 1 day
4

Mean lactate area under curve (AUC) (Cohort B)

Means and standard deviations for lactate area under curve will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.

Time frame
Baseline, 1 day

Secondary outcomes

1

Optimal cut-off value of peak lactate to pyruvate ratio (lac/pyr) (Cohort A)

Receiver-operative-curve analyses will be performed to determine the optimal cut-point of peak lac/pyr AUC on MRI that accurately detect primary Gleason 4 prostate cancer.

Time frame
Baseline, 1 day
2

Optimal cut-off value of peak lactate to pyruvate ratio (lac/pyr) (Cohort B)

Receiver-operative-curve analyses will be performed to determine the optimal cut-point of peak lac/pyr AUC on MRI that accurately detects in-field clinically significant (i.e. Gleason score \>3+3) recurrent/residual prostate cancer.

Time frame
Baseline, 1 day
3

Optimal cut-off value of lac/pyr area under the curve (AUC) (Cohort A)

Receiver-operative-curve analyses will be performed to determine the optimal cut-point of peak lac/pyr AUC values on MRI that accurately detect primary Gleason 4 prostate cancer

Time frame
Baseline, 1 day
4

Optimal cut-off value of lac/pyr area under the curve (AUC) (Cohort B)

Receiver-operative-curve analyses will be performed to determine the optimal cut-point of peak lac/pyr AUC values on MRI that accurately detects in-field clinically significant (ie. Gleason score \>3+3) recurrent/residual prostate cancer

Time frame
Baseline, 1 day

Other outcomes

Sponsors and contacts

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

Ivan de Kouchkovsky, MD

Lead sponsor

University of California, San Francisco

Sponsor institution

American Cancer Society, Inc.

Collaborator

National Cancer Institute (NCI)

Collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Source ClinicalTrials.gov
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