Trial · NCT06391034
Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
NCT06391034, Phase 2, Active not recruiting, Robert Bok, MD, PhD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer. Trials, record NCT06391034. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06391034
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer
- NCT number
- NCT06391034
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 161 participants, estimated
- Lead sponsor
- Robert Bok, MD, PhD
- Conditions
- Prostate Cancer
- Interventions
hyperpolarized pyruvate +/-urea (13C/15N), Non-investigational External beam radiotherapy (EBRT), Radiotherapy (RT), Multi-parametric magnetic resonance imaging (mpMRI), Non-interventional hormone therapy, Prostate Biopsy
- First posted
- 2024-04-30
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Signal-to-noise ratio (Part 1) | Day of MR imaging (1 day) | A signal-to-noise ratio is defined as a MR/spectroscopy parameter, consisting of the HP C13-Pyruvate or Lactate signal (peak) relative to background noise level (baseline) in MRI spectra of the tissue. |
| Primary | Mean HP 13C-pyruvate to lactate metabolic rate of conversion (kPL) over time (Part 2A) | Up to 24 months | The mean percent change in tumoral kPL between baseline and 1-year post-EBRT will be reported. |
| Primary | Mean HP 13C-pyruvate to glutamate metabolic rate of conversion (kPG) over time (Part 2A) | Up to 24 months | The mean percent change in tumoral kPG between baseline and 1-year post-EBRT will be reported. |
| Primary | Mean change in on-treatment kPL over time (Part 2B) | Up to 24 months | Mean percent change in tumoral kPL for participants receiving systemic hormone therapy between baseline and 1 -year post-EBRT will be reported. |
| Primary | Mean change in on-treatment kPG over time (Part 2B) | Up to 24 months | Mean percent change in tumoral kPG for participants receiving systemic hormone therapy between baseline and 1 -year post-EBRT will be reported. |
| Primary | Mean kPL at time of biochemical failure (Part 3) | Up to 24 months | The mean kPL for participants with biochemical failure will be reported. |
| Primary | Mean kPG at time of biochemical failure (Part 3) | Up to 24 months | The mean kPG for participants with biochemical failure will be reported. |
| Secondary | Intra-patient variability of kPL | Up to 12 months | Intra-patient variability in the kPL will be summarized by the intraclass correlation and presented with a 90% confidence interval when multiple HP-MRI scans are obtained for a participant. |
| Secondary | Intra-patient variability of kPG | Up to 12 months | Intra-patient variability in the kPG will be summarized by the intraclass correlation and presented with a 90% confidence interval when multiple HP-MRI scans are obtained for a participant. |
| Secondary | Mean intra-tumoral kPL above and below the median PSA (Parts 2-3) and the mean serum PSA | Up to 24 months | The study cohort will be dichotomized by mean intra-tumoral kPL obtained at baseline with median serum PSA and will be compared between the two dichotomized subgroups using Mann-Whitney test. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA238379 | Hyperpolarized C-13 MRI Techniques to Monitor Radiation Therapy Response in Prostate Cancer Patients | VIGNERON, DANIEL B; BOK, ROBERT A | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL CANCER INSTITUTE | 2021 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06391034
GET https://conductscience.org/api/trials/v1/NCT06391034/registered