Prostate CancerEarly Phase 1NCT02526368
Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer
A Early Phase 1 study testing Hyperpolarized 13C-Pyruvate, Hyperpolarized 13C,15N2-urea and Magnetic Resonance Spectroscopic Imaging in people with Prostate Cancer and Localized Prostate Carcinoma, run by Ivan de Kouchkovsky, MD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Localized Prostate Carcinoma
- What is being tested?
- Hyperpolarized 13C-Pyruvate, Hyperpolarized 13C,15N2-urea and Magnetic Resonance Spectroscopic Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2016to 31 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Note: The use of an endorectal coil may be waived at the discretion of the Principal Investigator upon review of available imaging with radiology, in which case this exclusion criterion will not apply.
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Louise Magat, (415) 502-1822, Louise.Magat@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer
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
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate the association between hyperpolarized (HP) pyruvate-to-lactate conversion (kPL) and HP urea perfusion with histologic grade of prostate cancer, including benign prostate tissue, low grade disease (primary Gleason score < 4), and high grade (primary Gleason score >= 4) prostate cancer (Cohort A).
II. To investigate the association between HP pyruvate-to-lactate conversion (kPL) and HP urea perfusion with in-field clinically significant (Gleason score >3+3) recurrent/residual prostate cancer following non-investigational High-Intensity Focused Ultrasound (HIFU) focal therapy (Cohort B)
SECONDARY OBJECTIVES:
- Safety.
II. To determine the optimal cut-off value of peak lactate to pyruvate ratio (lac/pyr), lac/pyr area under the curve (AUC), 13C pyruvate to lactate (kPL) rate, urea AUC, and urea transfer constant (ktrans) on magnetic resonance imaging (MRI) that accurately detects primary Gleason 4 component cancer (Cohort A).
III. To determine the optimal cut-off value of peak lac/pyr, lac/pyr AUC, kPL Urea AUC, Urea ktrans and kPL-urea product (kUP) on MRI that accurately detects in-field clinically significant (ie. Gleason score >3+3) recurrent/residual prostate cancer (Cohort B only).
IV. To determine the reproducibility of peak lac/pyr, lac/pyr AUC and kPL, urea AUC and urea transfer constant (ktrans) with same-day repeated dose studies. with same-day repeated dose studies.
- To compare peak lac/pyr, lac/pyr AUC and kPL, urea AUC, urea transfer constant (ktrans) on MRI with Prostate Imaging-Reporting and Data System (PI-RADS) assessment of multiparametric MRI in predicting regions of cancer versus benign tissue.
EXPLORATORY OBJECTIVES:
- To correlate histologic markers, including lactate dehydrogenase A (LDHA) expression and activity level, along with Ki-67, MYC, and MCT 1 and 4 expression, with peak intra-tumoral lac/pyr ratio, lactate AUC, and kPL detected using anatomically aligned magnetic resonance (MR) cross-sectional images of the prostate gland.
II. To test for an association between mean intra-tumoral lac/pyr signal and lactate AUC, kPL, urea AUC, and urea transfer constant (ktrans) with adverse clinical and pathologic characteristics including extracapsular extension, positive nodal involvement, and failure to achieve undetectable prostate specific antigen (PSA) nadir following prostatectomy.
OUTLINE:
Participants receive either hyperpolarized carbon pyruvate (13C) or co-polarized 13C pyruvate and 13C, 15N2urea intravenously (IV) and undergo MRSI within 12 weeks of undergoing non-investigational radical prostatectomy (cohort A) or non-investigational systematic and MR-targeted biopsies (cohort B). Participants may receive optional second hyperpolarized 13C injection and dynamic 13C MRI scan performed within 15 to 60 minutes following completion of first scan.
After completion of study, participants are followed up at 24 hours.
- Conditions
- Prostate Cancer, Localized Prostate Carcinoma
- Being tested
- Hyperpolarized 13C-Pyruvate, Hyperpolarized 13C,15N2-urea, Magnetic Resonance Spectroscopic Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized 13C-PyruvateDrug
Also called Hyperpolarized Pyruvate (13C)
Given IV
Hyperpolarized 13C,15N2-ureaDrug
Also called Urea C-13, C13 Urea
Given IV
Magnetic Resonance Spectroscopic ImagingProcedure or surgery
Also called MRSI, MRS, 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, MRS Imaging
Undergo MRSI
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hyperpolarized 13C-Pyruvate; Drug: Hyperpolarized 13C,15N2-urea; Procedure: 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 Receives: Drug: Hyperpolarized 13C-Pyruvate; Drug: Hyperpolarized 13C,15N2-urea; Procedure: Magnetic Resonance Spectroscopic Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: 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.
Measured: 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)).
Measured: 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.
Measured: 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)).
Measured: 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.
Measured: 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)).
Measured: 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.
Measured: 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)).
Measured: 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.
Measured: Baseline, 1 day
Secondary outcomes (21)
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.
Measured: Baseline, 1 day
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.
Measured: Baseline, 1 day
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
Measured: Baseline, 1 day
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
Measured: Baseline, 1 day
Optimal cut-off value of 13C pyruvate to lactate (kPL) rate (Cohort A)
Receiver-operative-curve analyses will be performed to determine the optimal cut-point of kPL on MRI that accurately detect primary Gleason 4 prostate cancer.
Measured: Baseline, 1 day
Optimal cut-off value of 13C pyruvate to lactate (kPL) rate (Cohort B)
Receiver-operative-curve analyses will be performed to determine the optimal cut-point of kPL on MRI that accurately detects in-field clinically significant (ie. Gleason score >3+3) recurrent/residual prostate cancer
Measured: Baseline, 1 day
Optimal cut-off value of urea AUC (Cohort A)
Receiver-operative-curve analyses will be performed to determine the optimal cut-point of urea AUC on MRI that accurately detect primary Gleason 4 prostate cancer.
Measured: Baseline, 1 day
Optimal cut-off value of urea AUC (Cohort B)
Receiver-operative-curve analyses will be performed to determine the optimal cut-point of urea AUC on MRI that accurately detects in-field clinically significant (ie. Gleason score >3+3) recurrent/residual prostate cancer
Measured: Baseline, 1 day
Optimal cut-off value of urea transfer constant (ktrans) (Cohort A)
Receiver-operative-curve analyses will be performed to determine the optimal cut-point of urea ktrans on MRI that accurately detect primary Gleason 4 prostate cancer.
Measured: Baseline, 1 day
Optimal cut-off value of urea transfer constant (ktrans) (Cohort B)
Receiver-operative-curve analyses will be performed to determine the optimal cut-point of urea ktrans on MRI that accurately detects in-field clinically significant (ie. Gleason score >3+3) recurrent/residual prostate cancer
Measured: Baseline, 1 day
Proportion of participants with Treatment-Related Adverse Events
Assessment of the occurrence of clinically significant changes in safety variables from baseline. Safety endpoints include monitoring for the occurrence of treatment-emergent AEs. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0.
Measured: Baseline, 1 day
Compare lactate/pyruvate area under curve (AUC) with Prostate Imaging Reporting and Data System (PI-RADS)
To compare lactate/pyruvate AUC on MRI with PI-RADS assessment of multiparametric MRI in predicting regions of cancer versus benign tissue. Radiologists use the PI-RADS to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious).
Measured: Baseline, 1 day
Compare peak lactate/pyruvate with PI-RADS
To compare peak lactate/pyruvate on MRI with PI-RADS assessment of multiparametric MRI in predicting regions of cancer versus benign tissue. Radiologists use the PI-RADS to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious).
Measured: Baseline, 1 day
Compare pyruvate to lactate (kPL) with PI-RADS
To compare peak pyruvate to lactate (kPL) on MRI with PI-RADS assessment of multiparametric MRI in predicting regions of cancer versus benign tissue. Radiologists use the PI-RADS to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious).
Measured: Baseline, 1 day
Compare urea AUC with PI-RADS
To compare urea AUC on MRI with PI-RADS assessment of multiparametric MRI in predicting regions of cancer versus benign tissue. Radiologists use the PI-RADS to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious).
Measured: Baseline, 1 day
Compare urea transfer constant (Ktrans) with PI-RADS
To compare urea ktrans on MRI with PI-RADS assessment of multiparametric MRI in predicting regions of cancer versus benign tissue. Radiologists use the PI-RADS to report how likely it is that a suspicious area is a clinically significant cancer. PI-RADS scores range from 1 (most likely not cancer) to 5 (very suspicious).
Measured: Baseline, 1 day
Mean difference in Intra-patient peak lac/pyr
Intra-patient reproducibility of peak lac/pyr for patients who undergo repeated dose imaging studies, as descriptively reported using summary statistics.
Measured: Baseline, 1 day
Mean difference in Intra-patient lac/pyr AUC
Intra-patient reproducibility of lac/pyr AUC for patients who undergo repeated dose imaging studies, as descriptively reported using summary statistics.
Measured: Baseline, 1 day
Mean difference in Intra-patient kPL
Intra-patient reproducibility of kPL for patients who undergo repeated dose imaging studies, as descriptively reported using summary statistics.
Measured: Baseline, 1 day
Mean difference in Intra-patient Urea AUC
Intra-patient reproducibility of Urea AUC for patients who undergo repeated dose imaging studies, as descriptively reported using summary statistics.
Measured: Baseline, 1 day
Mean difference in Intra-patient Urea ktrans
Intra-patient reproducibility of Urea ktrans for patients who undergo repeated dose imaging studies, as descriptively reported using summary statistics
Measured: Baseline, 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study start22 Mar 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ivan de Kouchkovsky, MD
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor-investigator, Ivan de Kouchkovsky, MD, University of California, San Francisco
- Investigators
- Ivan de Kouchkovsky, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526368
- Sponsor's protocol ID
- 15557
- Other IDs
- R01CA211150, U01EB026412, R01EB017449, R01CA214554, R01CA238379, R01CA300053, NCI-2015-02008
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2015
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) to Detect High Grade Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02526368
- Acronym / sponsor ID
- 15557
- Conditions
- Prostate Cancer, Localized Prostate Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ivan de Kouchkovsky, MDUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., National Cancer Institute (NCI), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVES:
- To investigate the association between hyperpolarized (HP) pyruvate-to-lactate conversion (kPL) and HP urea perfusion with histologic grade of prostate cancer, including benign prostate tissue, low grade disease (primary Gleason score < 4), and high grade (primary Gleason score >= 4) prostate cancer (Cohort A).
II. To investigate the association between HP pyruvate-to-lactate conversion (kPL) and HP urea perfusion with in-field clinically significant (Gleason score >3+3) recurrent/residual prostate cancer following non-investigational High-Intensity Focused Ultrasound (HIFU) focal therapy (Cohort B)
SECONDARY OBJECTIVES:
- Safety.
II. To determine the optimal cut-off value of peak lactate to pyruvate ratio (lac/pyr), lac/pyr area under the curve (AUC), 13C pyruvate to lactate (kPL) rate, urea AUC, and urea transfer constant (ktrans) on magnetic resonance imaging (MRI) that accurately detects primary Gleason 4 component cancer (Cohort A).
III. To determine the optimal cut-off value of peak lac/pyr, lac/pyr AUC, kPL Urea AUC, Urea ktrans and kPL-urea product (kUP) on MRI that accurately detects in-field clinically significant (ie. Gleason score >3+3) recurrent/residual prostate cancer (Cohort B only).
IV. To determine the reproducibility of peak lac/pyr, lac/pyr AUC and kPL, urea AUC and urea transfer constant (ktrans) with same-day repeated dose studies. with same-day repeated dose studies.
- To compare peak lac/pyr, lac/pyr AUC and kPL, urea AUC, urea transfer constant (ktrans) on MRI with Prostate Imaging-Reporting and Data System (PI-RADS) assessment of multiparametric MRI in predicting regions of cancer versus benign tissue.
EXPLORATORY OBJECTIVES:
- To correlate histologic markers, including lactate dehydrogenase A (LDHA) expression and activity level, along with Ki-67, MYC, and MCT 1 and 4 expression, with peak intra-tumoral lac/pyr ratio, lactate AUC, and kPL detected using anatomically aligned magnetic resonance (MR) cross-sectional images of the prostate gland.
II. To test for an association between mean intra-tumoral lac/pyr signal and lactate AUC, kPL, urea AUC, and urea transfer constant (ktrans) with adverse clinical and pathologic characteristics including extracapsular extension, positive nodal involvement, and failure to achieve undetectable prostate specific antigen (PSA) nadir following prostatectomy.
OUTLINE:
Participants receive either hyperpolarized carbon pyruvate (13C) or co-polarized 13C pyruvate and 13C, 15N2urea intravenously (IV) and undergo MRSI within 12 weeks of undergoing non-investigational radical prostatectomy (cohort A) or non-investigational systematic and MR-targeted biopsies (cohort B). Participants may receive optional second hyperpolarized 13C injection and dynamic 13C MRI scan performed within 15 to 60 minutes following completion of first scan.
After completion of study, participants are followed up at 24 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Pre-surgical Prostate Cancer patients | Experimental | Drug: Hyperpolarized 13C-Pyruvate, Drug: Hyperpolarized 13C,15N2-urea, Procedure: Magnetic Resonance Spectroscopic ImagingParticipants 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. |
| Cohort B: Post-HIFU Participants | Experimental | Drug: Hyperpolarized 13C-Pyruvate, Drug: Hyperpolarized 13C,15N2-urea, Procedure: Magnetic Resonance Spectroscopic ImagingParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
- Note: The use of an endorectal coil may be waived at the discretion of the Principal Investigator upon review of available imaging with radiology, in which case this exclusion criterion will not apply.
- Patients with contra-indications to injection of gadolinium contrast; for example patients with prior documented allergy or those with inadequate renal function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized 13C-PyruvateAlso: Hyperpolarized Pyruvate (13C)Given IV | Drug | Cohort A: Pre-surgical Prostate Cancer patients, Cohort B: Post-HIFU Participants |
| Hyperpolarized 13C,15N2-ureaAlso: Urea C-13, C13 UreaGiven IV | Drug | Cohort A: Pre-surgical Prostate Cancer patients, Cohort B: Post-HIFU Participants |
| Magnetic Resonance Spectroscopic ImagingAlso: MRSI, MRS, 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, MRS ImagingUndergo MRSI | Procedure or surgery | Cohort A: Pre-surgical Prostate Cancer patients, Cohort B: Post-HIFU Participants |
Primary outcome
Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio by pathological grade (Cohort A)
Time frame: Baseline, 1 day
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)).
Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio (Cohort B)
Time frame: Baseline, 1 day
Means and standard deviations for lactate area under curve will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.
Mean lactate area under curve (AUC) by pathological grade (Cohort A)
Time frame: Baseline, 1 day
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)).
Mean lactate area under curve (AUC) (Cohort B)
Time frame: Baseline, 1 day
Means and standard deviations for lactate area under curve will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.
Mean peak conversion of HP 13C pyruvate to lactate (kPL) by pathological grade (Cohort A)
Time frame: Baseline, 1 day
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)).
Mean peak conversion of HP 13C pyruvate to lactate (kPL) (Cohort B)
Time frame: Baseline, 1 day
Means and standard deviations for kPL will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.
Mean Urea AUC by pathological grade (Cohort A)
Time frame: Baseline, 1 day
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)).
Mean Urea AUC (Cohort B)
Time frame: Baseline, 1 day
Means and standard deviations for Urea AUC will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.
Mean urea transfer constant (Ktrans) by pathological grade (Cohort A)
Time frame: Baseline, 1 day
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)).
Mean urea transfer constant (Ktrans) (Cohort B)
Time frame: Baseline, 1 day
Means and standard deviations for Ktrans will be calculated for those with in-field recurrent/residual clinically significant prostate cancer.
21 secondary outcomes
Optimal cut-off value of peak lactate to pyruvate ratio (lac/pyr) (Cohort A)
Time frame: Baseline, 1 day
Optimal cut-off value of peak lactate to pyruvate ratio (lac/pyr) (Cohort B)
Time frame: Baseline, 1 day
Optimal cut-off value of lac/pyr area under the curve (AUC) (Cohort A)
Time frame: Baseline, 1 day
Optimal cut-off value of lac/pyr area under the curve (AUC) (Cohort B)
Time frame: Baseline, 1 day
Optimal cut-off value of 13C pyruvate to lactate (kPL) rate (Cohort A)
Time frame: Baseline, 1 day
Optimal cut-off value of 13C pyruvate to lactate (kPL) rate (Cohort B)
Time frame: Baseline, 1 day
Optimal cut-off value of urea AUC (Cohort A)
Time frame: Baseline, 1 day
Optimal cut-off value of urea AUC (Cohort B)
Time frame: Baseline, 1 day
Optimal cut-off value of urea transfer constant (ktrans) (Cohort A)
Time frame: Baseline, 1 day
Optimal cut-off value of urea transfer constant (ktrans) (Cohort B)
Time frame: Baseline, 1 day
Proportion of participants with Treatment-Related Adverse Events
Time frame: Baseline, 1 day
Compare lactate/pyruvate area under curve (AUC) with Prostate Imaging Reporting and Data System (PI-RADS)
Time frame: Baseline, 1 day
Compare peak lactate/pyruvate with PI-RADS
Time frame: Baseline, 1 day
Compare pyruvate to lactate (kPL) with PI-RADS
Time frame: Baseline, 1 day
Compare urea AUC with PI-RADS
Time frame: Baseline, 1 day
Compare urea transfer constant (Ktrans) with PI-RADS
Time frame: Baseline, 1 day
Mean difference in Intra-patient peak lac/pyr
Time frame: Baseline, 1 day
Mean difference in Intra-patient lac/pyr AUC
Time frame: Baseline, 1 day
Mean difference in Intra-patient kPL
Time frame: Baseline, 1 day
Mean difference in Intra-patient Urea AUC
Time frame: Baseline, 1 day
Mean difference in Intra-patient Urea ktrans
Time frame: Baseline, 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivan de Kouchkovsky, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hyperpolarized 13C-Pyruvate, Hyperpolarized 13C,15N2-urea and Magnetic Resonance Spectroscopic Imaging in people with Prostate Cancer and Localized Prostate Carcinoma, run by Ivan de Kouchkovsky, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louise Magat ((415) 502-1822, Louise.Magat@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio by pathological grade (Cohort A) (time frame: Baseline, 1 day). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.