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NCT06391034

Magnetic Resonance (MR) Imaging With Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea in Patients With Prostate Cancer

StatusActive, Not Recruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 10 words Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Interventions: Multi-parametric magnetic resonance imaging (mpMRI) (Procedure), Non-interventional hormone therapy (Biological), Non-investigational… to Multi-parametric magnetic resonance imaging (mpMRI) (Procedure), Non-interventional hormone therapy (Biological), Non-investigational…
    • Secondary endpoints: details revised at 2 of 8 entries
    • Study description revised
    • Site details revised
  2. Eligibility criteria revised
    • Interventions: Multi-parametric magnetic resonance imaging (mpMRI) (Procedure), Non-interventional hormone therapy (Biological), Non-investigational… to Multi-parametric magnetic resonance imaging (mpMRI) (Procedure), Non-interventional hormone therapy (Biological), Non-investigational…
    • Site contact updated
    • Study description expanded, about 5 words
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Jun 1, 2024 to Sep 24, 2024
    • Primary completion date: Sep 30, 2028 to Dec 31, 2028
    • Study completion date: Jun 30, 2032 to Oct 31, 2032
    • Site details revised
  4. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Signal-to-noise ratio (Part 1)
Timeframe: Day of MR imaging (1 day)
Mean HP 13C-pyruvate to lactate metabolic rate of conversion (kPL) over time (Part 2A)
Timeframe: Up to 24 months
Mean HP 13C-pyruvate to glutamate metabolic rate of conversion (kPG) over time (Part 2A)
Timeframe: Up to 24 months
Mean change in on-treatment kPL over time (Part 2B)
Timeframe: Up to 24 months
Mean change in on-treatment kPG over time (Part 2B)
Timeframe: Up to 24 months
Mean kPL at time of biochemical failure (Part 3)
Timeframe: Up to 24 months
Mean kPG at time of biochemical failure (Part 3)
Timeframe: Up to 24 months

Secondary (8)

Intra-patient variability of kPL
Intra-patient variability of kPG
Mean intra-tumoral kPL above and below the median PSA (Parts 2-3) and the mean serum PSA
Correlation of kPL with Prostate Imaging Reporting and Data System (PI-RADS) version 2 classification score
Correlation of kPG with PI-RADS version 2 classification score
Show 3 moreShow less
Proportion of participants with concordant mismatch of low HP 13C-urea perfusion (ureaAUC)
Mean percent change in kPL over time for participants with optional scan
Number of participants with reported treatment-related adverse events

Arms and interventions

Part 1: Image Optimization GroupExperimental

Participants will undergo Hyperpolarized 13C-Pyruvate +/- 13C,15N-Urea imaging as part of a multi-parametric magnetic resonance imaging (mpMRI) exam, with the primary objective of optimizing imaging sequences and techniques to maximize signal-to-noise ratio of imaging modality.

Part 2A: Prospective imaging (External beam radiotherapy (EBRT) Participants)Experimental

Participants with pre-planned, non-interventional stereotactic body radiotherapy (EBRT) will undergo an HP Pyruvate +/-Urea mpMRI exam at baseline, at 3 months post-EBRT treatment and at 1yr post-treatment.

Part 2B: Prospective imaging (High-risk localized prostate cancer)Experimental

Participants with with high-risk localized prostate cancer and have pre-planned, non-interventional primary radiation therapy (RT) with concurrent, systemic, non-interventional hormone therapy will undergo HP Pyruvate+/-Urea mpMRI at baseline prior to the start of systemic hormone therapy, 4-12 weeks after the initiation of systemic hormone therapy (prior to radiation therapy), at 3 months post-radiation therapy, and at +1yr post-radiation therapy.

Part 3: EBRT participants at time of biochemical recurrence (BCR)Experimental

Evaluable EBRT participants who undergo HP Pyruvate +/-Urea mpMRI at time of biochemical failure, followed by magnetic resonance (MR) / ultrasound (US) fusion-guided prostate biopsy within 12 weeks following baseline MR exam. Participants in this group have the option of undergoing a follow up HP Pyruvate +/-Urea MR exam 6-15 months following the baseline scan, to evaluate for any interval change.

Drugs: hyperpolarized pyruvate +/-urea (13C/15N)

Radiation: Non-investigational External beam radiotherapy (EBRT)

Procedures: Radiotherapy (RT), Multi-parametric magnetic resonance imaging (mpMRI), Prostate Biopsy

Biologicals: Non-interventional hormone therapy

Sites

1 site in 1 country

  • University of California, San FranciscoSan Francisco, California, United States