NCT02526368

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for early_phase_1 prostate-cancer

Timeline
8mo left

Started Mar 2016

Longer than P75 for early_phase_1 prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2016Dec 2026

First Submitted

Initial submission to the registry

August 14, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

March 22, 2016

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

10.8 years

First QC Date

August 14, 2015

Last Update Submit

April 24, 2026

Conditions

Localized Prostate CarcinomaProstate Cancer

Outcome Measures

Primary Outcomes (10)

  • 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)).

    Baseline, 1 day

  • 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.

    Baseline, 1 day

  • 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)).

    Baseline, 1 day

  • 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.

    Baseline, 1 day

  • Mean peak conversion of HP 13C pyruvate to lactate (kPL) by pathological grade (Cohort A)

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

    Baseline, 1 day

  • Mean peak conversion of HP 13C pyruvate to lactate (kPL) (Cohort B)

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

    Baseline, 1 day

  • Mean Urea AUC by pathological grade (Cohort A)

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

    Baseline, 1 day

  • Mean Urea AUC (Cohort B)

    Means and standard deviations for Urea AUC will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.

    Baseline, 1 day

  • Mean urea transfer constant (Ktrans) by pathological grade (Cohort A)

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

    Baseline, 1 day

  • Mean urea transfer constant (Ktrans) (Cohort B)

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

    Baseline, 1 day

Secondary Outcomes (21)

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

    Baseline, 1 day

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

    Baseline, 1 day

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

    Baseline, 1 day

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

    Baseline, 1 day

  • Optimal cut-off value of 13C pyruvate to lactate (kPL) rate (Cohort A)

    Baseline, 1 day

  • +16 more secondary outcomes

Study Arms (2)

Cohort A: Pre-surgical Prostate Cancer patients

EXPERIMENTAL

Participants will receive an infusion of hyperpolarized 13C-pyruvate alone or co-hyperpolarized 13C pyruvate with hyperpolarized 13C, 15N urea injection prior to metabolic/perfusion high spatial resolution MRI/1H MRSI staging exam (PROSE) with endorectal coil using both a phased-array abdominal coil and an endorectal coil will be performed within 12 weeks of subsequent non-investigational radical prostatectomy.

Drug: Hyperpolarized 13C-PyruvateDrug: Hyperpolarized 13C,15N2-ureaProcedure: Magnetic Resonance Spectroscopic Imaging

Cohort B: Post-HIFU Participants

EXPERIMENTAL

Participants will receive an infusion of hyperpolarized 13C-pyruvate alone or co-hyperpolarized 13C pyruvate with hyperpolarized 13C, 15N urea injection prior to metabolic/perfusion high spatial resolution MRI/1H MRSI staging exam (PROSE) with endorectal coil using both a phased-array abdominal coil and an endorectal coil will be performed for participants with planned post-HIFU surveillance systematic and MR-targeted non-investigational biopsies

Drug: Hyperpolarized 13C-PyruvateDrug: Hyperpolarized 13C,15N2-ureaProcedure: Magnetic Resonance Spectroscopic Imaging

Interventions

Hyperpolarized 13C-PyruvateDRUG

Given IV

Also known as: Hyperpolarized Pyruvate (13C)
Cohort A: Pre-surgical Prostate Cancer patientsCohort B: Post-HIFU Participants
Hyperpolarized 13C,15N2-ureaDRUG

Given IV

Also known as: Urea C-13, C13 Urea
Cohort A: Pre-surgical Prostate Cancer patientsCohort B: Post-HIFU Participants
Magnetic Resonance Spectroscopic ImagingPROCEDURE

Undergo MRSI

Also known as: MRSI, MRS, 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, MRS Imaging
Cohort A: Pre-surgical Prostate Cancer patientsCohort B: Post-HIFU Participants

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

  • 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.
  • Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging.
  • Cryosurgery, surgery for prostate cancer, prostatic or pelvic radiotherapy prior to study enrollment. For Cohort B, HIFU focal therapy is allowed. No limit on number of prior prostate biopsies; prior transurethral prostatic resection (TURP) is not allowed.
  • Current or prior androgen deprivation therapy. For Cohort A, a history of use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry. For cohort B, a history of use of 5-α reductase inhibitor is allowed, provided it is discontinued at least 14 days to protocol MRI/MRSI.
  • Poorly controlled hypertension, with blood pressure at study entry \> 160/100; the addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.
  • Congestive heart failure or New York Heart Association (NYHA) status \>= 2.
  • A history of clinically significant electrocardiography (EKG) abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry; patients with rate-controlled atrial fibrillation/flutter will be allowed on study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Ivan de Kouchkovsky, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise Magat

CONTACT

(415) 502-1822Louise.Magat@ucsf.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Clinical Professor

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 18, 2015

Study Start

March 22, 2016

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)