Prostate AdenocarcinomaNCT04286386
Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam
An observational study of Prostate Adenocarcinoma, run by M.D. Anderson Cancer Center.
Trial summary
This trial examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of a clinical prostate cancer exam. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Spectroscopic Imaging and Surgical Procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2019to 30 Apr 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients with biopsy proven prostate cancer that are enrolled in an active surveillance protocol, and patients that are scheduled for prostatectomy at MD Anderson
Who may be able to join
- Biopsy proven prostate adenocarcinoma (Arm 1 \& 2)
- Clinically appropriate for active surveillance (Arm 1)
- Prior prostate biopsy must have been performed at least 5 weeks prior imaging (Arm 1 \& 2)
- Patient must be scheduled to undergo radical prostatectomy within 6 months of multi-parametric magnetic resonance imaging (MP-MRI) + hyperpolarized (HP) [1-13C]-pyruvate imaging, consistent with American College of Radiology Imaging Network (ACRIN) Protocol: ACRIN 6659 (Arm 2)
- At least 10% of enrolled patients will have high risk of disease progression (Cancer of the Prostate Risk Assessment - [CAPRA] 6-10) and no more than 50% of enrolled patients will have low risk of progression (CAPRA < 3) (Arm 2)
Who cannot join
- Contraindication to MRI (Arm 1 \& 2)
- Allergy to gadavist intravenous contrast (Arm 1 \& 2)
- Any known medical history of arrhythmias such as atrial fib, etc. (Arm 1 \& 2)
- Prior therapy for prostate cancer, except for 5-alpha reductase inhibitor discontinued at least one month prior to imaging (Arm 1 \& 2)
About this study
Official title: Development &Amp; Evaluation of a Quantitative HP MRI Clinical Prostate Cancer Exam
This trial examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of a clinical prostate cancer exam. 3T refers to the strength of the magnetic resonance spectroscopic imaging (MRSI) machine. MRSI is a magnetic resonance imaging (MRI) technique that can show certain chemical differences in healthy and diseased prostate tumor tissue compared to standard multiparametric MRI that may not detect the tumor. Hyperpolarized (HP) 13-C pyruvate is a contrast drug that may help the scanner see the tumor site better during imaging. Hyperpolarization of 13-C pyruvate may allow pyruvate and its metabolites to be detected upon injection, which in turn, allow the prostate cancer to be found and treated.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including kpl, which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest, using a test-retest study design.
II. To test the reproducibility of the normalized area under the lactate curve (nLac), a semi-quantitative biomarker for tumor metabolism.
SECONDARY OBJECTIVES:
- To provide initial assessment of the sensitivity and specificity of hyperpolarized 13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer.
II. To assess the correlation between kpl and tumor grade.
OUTLINE: Patients are assigned to 1 of 3 arms.
ARM Ia: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRSI at least 5 weeks after prostate cancer biopsy.
ARM Ib: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after.
ARM II: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after.
After the completion of study, patients in Arm Ia and Arm Ib are followed up once.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Spectroscopic Imaging, Surgical Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized Carbon C 13 PyruvateOther
Also called Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)
Given IV
Magnetic Resonance Spectroscopic ImagingProcedure or surgery
Also called 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS
Undergo MRSI
Surgical ProcedureProcedure or surgery
Also called Operation, surgery, Surgical, Surgical Interventions
Undergo standard of care surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm Ia (MRSI) | Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy. Receives: Other: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Spectroscopic Imaging | |
| Arm Ib (MRSI) | Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after. Receives: Other: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Spectroscopic Imaging | |
| Arm II (MRSI, surgery) | Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after. Receives: Other: Hyperpolarized Carbon C 13 Pyruvate; Procedure: Magnetic Resonance Spectroscopic Imaging; Procedure: Surgical Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of the kpl measurement
Will be assessed using a test-retest study design. Will be summarized by the intra-class correlation coefficient (ICC). Data from patients at both MD Anderson and University of San Fransisco, San Fransisco (UCSF) will be pooled if possible to increase significance. Bland-Altman analysis will be included if the ICC proves unreliable as a measure of reproducibility. ICC is sensitive to data range; thus, Bland-Altman plot, limits of agreement, repeatability coefficient, and the within-patient coefficient of variation (wCV) may be included as appropriate.
Measured: 3 years
Reproducibility of the normalized area under the lactate curve (nLac)
Will be carried out using data from N=40 patients on active surveillance at MD Anderson. Will be summarized by the ICC. Data from patients at both MD Anderson and University of San Fransisco, San Fransisco (UCSF) will be pooled if possible to increase significance. Bland-Altman analysis will be included if the ICC proves unreliable as a measure of reproducibility. ICC is sensitive to data range; thus, Bland-Altman plot, limits of agreement, repeatability coefficient, and the within-patient coefficient of variation (wCV) may be included as appropriate.
Measured: 3 years
Secondary outcomes (3)
Specificity of HP 13-C-pyruvate MRSI for detecting high risk localized prostate cancer
Analysis will be restricted to lesions > 0.5 cc and the 3 most significant pathologic cancer foci from each patient. Specificity will be calculated as the ratio of true negatives to the sum of true negatives and false positives. Specificity will be assessed using pooled data from MD Anderson (N=25) and UCSF (N=25). A ROC analysis will be carried out.
Measured: 3 years
Sensitivity of hyperpolarized (HP) 13-C-pyruvate magnetic resonance spectroscopy imaging (MRSI) for detecting high risk localized prostate cancer
Analysis will be restricted to lesions > 0.5 cc and the 3 most significant pathologic cancer foci from each patient. Sensitivity will be calculated as the ratio of true positives (matches) to the sum of true positives and false negatives. Sensitivity will be assessed using pooled data from MD Anderson (N=25) and UCSF (N=25). A receiver operating characteristic (ROC) analysis will be carried out.
Measured: 3 years
Kpl
Correspondence between kpl, imaging biomarkers from the multiparametric MRI exam, and tumor grade will be assessed. Imaging biomarkers will be compared with pathologic grade (benign, Epstein grade grouping 1; intermediate, Epstein 2-3; and high-grade, Epstein 4-5) using analysis of variance (ANOVA) with Newman-Keuls post-hoc test to determine associations.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start19 Dec 2019
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Why it stopped: No Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tharakeswara Bathala, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286386
- Sponsor's protocol ID
- 2018-1164
- Other IDs
- NCI-2020-00746, 2018-1164, R01CA211150
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2020
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development &Amp; Evaluation of a Quantitative HP MRI Clinical Prostate Cancer Exam
- ClinicalTrials.gov ID
- NCT04286386
- Acronym / sponsor ID
- 2018-1164
- Conditions
- Prostate Adenocarcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 27 Feb 2020 (actual)
- 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 trial examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of a clinical prostate cancer exam. 3T refers to the strength of the magnetic resonance spectroscopic imaging (MRSI) machine. MRSI is a magnetic resonance imaging (MRI) technique that can show certain chemical differences in healthy and diseased prostate tumor tissue compared to standard multiparametric MRI that may not detect the tumor. Hyperpolarized (HP) 13-C pyruvate is a contrast drug that may help the scanner see the tumor site better during imaging. Hyperpolarization of 13-C pyruvate may allow pyruvate and its metabolites to be detected upon injection, which in turn, allow the prostate cancer to be found and treated.
Detailed description
PRIMARY OBJECTIVES:
- To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including kpl, which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest, using a test-retest study design.
II. To test the reproducibility of the normalized area under the lactate curve (nLac), a semi-quantitative biomarker for tumor metabolism.
SECONDARY OBJECTIVES:
- To provide initial assessment of the sensitivity and specificity of hyperpolarized 13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer.
II. To assess the correlation between kpl and tumor grade.
OUTLINE: Patients are assigned to 1 of 3 arms.
ARM Ia: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRSI at least 5 weeks after prostate cancer biopsy.
ARM Ib: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after.
ARM II: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after.
After the completion of study, patients in Arm Ia and Arm Ib are followed up once.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm Ia (MRSI) | – | Other: Hyperpolarized Carbon C 13 Pyruvate, Procedure: Magnetic Resonance Spectroscopic ImagingPatients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy. |
| Arm Ib (MRSI) | – | Other: Hyperpolarized Carbon C 13 Pyruvate, Procedure: Magnetic Resonance Spectroscopic ImagingPatients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after. |
| Arm II (MRSI, surgery) | – | Other: Hyperpolarized Carbon C 13 Pyruvate, Procedure: Magnetic Resonance Spectroscopic Imaging, Procedure: Surgical ProcedurePatients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy proven prostate cancer that are enrolled in an active surveillance protocol, and patients that are scheduled for prostatectomy at MD Anderson
Key inclusion criteria (5 listed)
- Biopsy proven prostate adenocarcinoma (Arm 1 \& 2)
- Clinically appropriate for active surveillance (Arm 1)
- Prior prostate biopsy must have been performed at least 5 weeks prior imaging (Arm 1 \& 2)
- Patient must be scheduled to undergo radical prostatectomy within 6 months of multi-parametric magnetic resonance imaging (MP-MRI) + hyperpolarized (HP) [1-13C]-pyruvate imaging, consistent with American College of Radiology Imaging Network (ACRIN) Protocol: ACRIN 6659 (Arm 2)
- At least 10% of enrolled patients will have high risk of disease progression (Cancer of the Prostate Risk Assessment - [CAPRA] 6-10) and no more than 50% of enrolled patients will have low risk of progression (CAPRA < 3) (Arm 2)
Key exclusion criteria (4 listed)
- Contraindication to MRI (Arm 1 \& 2)
- Allergy to gadavist intravenous contrast (Arm 1 \& 2)
- Any known medical history of arrhythmias such as atrial fib, etc. (Arm 1 \& 2)
- Prior therapy for prostate cancer, except for 5-alpha reductase inhibitor discontinued at least one month prior to imaging (Arm 1 \& 2)
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 Carbon C 13 PyruvateAlso: Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)Given IV | Other | Arm II (MRSI, surgery), Arm Ia (MRSI), Arm Ib (MRSI) |
| Magnetic Resonance Spectroscopic ImagingAlso: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRSUndergo MRSI | Procedure or surgery | Arm II (MRSI, surgery), Arm Ia (MRSI), Arm Ib (MRSI) |
| Surgical ProcedureAlso: Operation, surgery, Surgical, Surgical InterventionsUndergo standard of care surgery | Procedure or surgery | Arm II (MRSI, surgery) |
Primary outcome
Reproducibility of the kpl measurement
Time frame: 3 years
Will be assessed using a test-retest study design. Will be summarized by the intra-class correlation coefficient (ICC). Data from patients at both MD Anderson and University of San Fransisco, San Fransisco (UCSF) will be pooled if possible to increase significance. Bland-Altman analysis will be included if the ICC proves unreliable as a measure of reproducibility. ICC is sensitive to data range; thus, Bland-Altman plot, limits of agreement, repeatability coefficient, and the within-patient coefficient of variation (wCV) may be included as appropriate.
Reproducibility of the normalized area under the lactate curve (nLac)
Time frame: 3 years
Will be carried out using data from N=40 patients on active surveillance at MD Anderson. Will be summarized by the ICC. Data from patients at both MD Anderson and University of San Fransisco, San Fransisco (UCSF) will be pooled if possible to increase significance. Bland-Altman analysis will be included if the ICC proves unreliable as a measure of reproducibility. ICC is sensitive to data range; thus, Bland-Altman plot, limits of agreement, repeatability coefficient, and the within-patient coefficient of variation (wCV) may be included as appropriate.
3 secondary outcomes
Specificity of HP 13-C-pyruvate MRSI for detecting high risk localized prostate cancer
Time frame: 3 years
Sensitivity of hyperpolarized (HP) 13-C-pyruvate magnetic resonance spectroscopy imaging (MRSI) for detecting high risk localized prostate cancer
Time frame: 3 years
Kpl
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Tharakeswara Bathala principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Adenocarcinoma, run by M.D. Anderson Cancer Center.
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 4 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: withdrawn, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of the kpl measurement (time frame: 3 years). The study lists 2 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 15 Sep 2026.