A Phase 1 interventional study of Pyruvate (13C) and MRI in Prostate Cancer, sponsored by Rahul Aggarwal. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-24.
Sponsored by Rahul Aggarwal · Phase 1, Interventional, and Diagnostic
This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging with Hyperpolarized Pyruvate (HP) (13C) as a predictive response biomarker to androgen signaling inhibition in patients with castration-resistant prostate cancer.
This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging as a predictive response biomarker to androgen signaling inhibition in patients with castration-resistant prostate cancer. Patients with a target lesion that is amenable for metabolic MR imaging will be eligible for study participation. Patients will undergo baseline metabolic MR imaging with Hyperpolarized Pyruvate C-13 pyruvate followed by initiation of androgen signaling inhibition (either as standard of care or as part of clinical trial; including abiraterone and/or enzalutamide treatment). Patient will subsequently undergo repeat metabolic MR scan after 28 days (+/- 7 days) of therapy. For those without primarily refractory disease, a third metabolic MR scan will be completed at the time of radiographic disease progression by The Prostate Cancer Clinical Trials Working Group 2 (PCWG2) criteria. MR- or CT-guided tumor biopsies are optional at baseline and at the time of disease progression.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 8 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Rahul Aggarwal is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Presence of at least one target lesion detected by standard staging scans that, in the judgment of Study Investigators, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging:
For patients with target lesion in prostate/prostatic bed:
i. No contra-indications to endorectal coil insertion (e.g., patients with a prior abdominoperineal resection of the rectum or latex allergy).
ii. No prior local treatment to the selected lesion. Patients who have received prior radiation or ablative therapy to the prostate will be required to have biopsy-proven evidence of disease recurrence following completion of local therapy.
For patients undergoing optional tumor biopsy:
Exclusion Criteria:
75 men with castration-resistant prostate cancer (CRPC) will undergo MR imaging with hyperpolarized 13C pyruvate of a pre-selected target lesion at baseline and after 1 month of treatment with an androgen signaling inhibitor. Patients with CRPC that is not primarily refractory (defined as disease progression by PCWG2 criteria within 6 months of treatment initiation) to Androgen Signaling Inhibitors (ASI) treatment will undergo a third metabolic MR scan at the time of disease progression. Patients may undergo optional MR- or CT-guided tumor biopsies at baseline and at the time of disease progression.
Drug: Pyruvate (13C) · Device: MRI
Pyruvate injection followed by an MRI scan.
Also known as: Hyperpolarized Pyruvate (13C)
MRI scan following the Pyruvate injection
Also known as: Magnetic Resonance Imaging
Mean difference in baseline intra-tumoral peak lac/pyr ratio on HP C-13 MRI in ASI-refractory versus ASI-responsive CRPC tumors
ASI-refractory disease is defined as progression by PCWG2 criteria within 6 months of treatment initiation. ASI-responsive disease includes all other tumors not meeting this criterion. A two sample t-test will be used to compare the mean intra-tumoral HP lac/pyr ratio between treatment-refractory versus treatment-responsive tumors. If a non-parametric distribution is observed, a Mann-Whitney test may also be used to compare the two groups.
Time frame: Up to 6 months
Association between change from baseline in peak intra-tumoral HP lac/pyr ratio after 28 days of ASI treatment with subsequent clinical outcomes on ASI treatment
For the purposes of analyzing the association between early change in lac/pyr ratio on HP MRI with subsequent clinical outcomes, the cohort will be dichotomized according to whether follow up scan 4 weeks (28 days) after starting treatment demonstrates increase versus decrease in peak intratumoral lac/pyr ratio compared to baseline. The Prostate-specific antigen (PSA) response rate (PCWG2 criteria) will be compared between dichotomized groups using the chi-squared test. The log rank test will be used to compare the radiographic progression-free survival between the two groups
Time frame: Up to 28 days
Mean percent change from baseline in peak intra-tumoral HP lac/pyr ratio on repeat metabolic MRI
The mean percent change from baseline in peak intra-tumoral HP lac/pyr ratio to repeat metabolic MRI obtained at the time of radiographic disease progression by PCWG2 criteria will be descriptively reported for the entire study cohort and for the subgroups of patients with treatment- refractory and treatment-responsive prostate cance
Time frame: Up to 6 months
Baseline peak intra-tumoral HP lac/pyr ratio cut-point that most accurately predicts for response versus refractoriness to subsequent ASI treatment
Receiver-operating-curve will be applied to determine the optimal cut-point of peak intra-tumoral lac/pyr values on MRI that accurately distinguish treatment-refractory versus treatment responsive prostate cancer.
Time frame: Baseline
Frequency of clinically significant changes in safety variables over time
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
Time frame: Up to 6 months
Mean Intra-patient reproducibility of HP lac/pyr ratio
Intra-patient reproducibility of HP lac/pyr ratio for patients who undergo repeated dose imaging studies, as descriptively reported using summary statistics
Time frame: Up to 6 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Rahul Aggarwal