Trial · NCT06391034
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Secondary | Correlation of kPL with Prostate Imaging Reporting and Data System (PI-RADS) version 2 classification score | Up to 24 months | Spearman's rank order correlation coefficient will be used to determine the relationship between kPL with PI-RADS version 2 classification score (1 through 5; PI-RADS 1 - Very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2 - Low (clinically significant cancer is unlikely to be present)). The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. |
| Secondary | Correlation of kPG with PI-RADS version 2 classification score | Up to 24 months | Spearman's rank order correlation coefficient will be used to determine the relationship between kPL with PI-RADS version 2 classification score (1 through 5; PI-RADS 1 - Very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2 - Low (clinically significant cancer is unlikely to be present)). The Spearman's correlation coefficient (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. |
| Secondary | Proportion of participants with concordant mismatch of low HP 13C-urea perfusion (ureaAUC) | Up to 24 months | A secondary endpoint will be to identify concordant mismatch of low HP 13C-urea perfusion (ureaAUC) in lesions assessed for kPL. |
| Secondary | Mean percent change in kPL over time for participants with optional scan | Up to 24 months | For the subset of participants who undergo optional follow up MR scan following baseline MRI, the mean percent change from baseline in kPL will be descriptively reported using summary statistics. |
| Secondary | Number of participants with reported treatment-related adverse events | From start of HP 13C-pyruvate MR imaging to 20 minutes after the procedure for all scans | The incidence of adverse events as graded by Common Toxicity Criteria version 5.0 will be determined |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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