NCT02450201

MRI With C13 Pilot Study Prostate Cancer

Terminated EARLY_PHASE1 Last updated 23 October 2018

What this trial tests

EARLY_PHASE1 trial testing Pyruvate in Prostate Cancer in 5 participants. Terminated before completion.

Timeline

12 October 2016

Primary endpoint
17 January 2017

17 January 2017

Quick facts

Lead sponsor	University of California, San Francisco
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	5
Start date	12 October 2016
Primary completion	17 January 2017
Estimated completion	17 January 2017
Sites	1 location across United States

Drugs / interventions tested

• Pyruvate — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University of California, San Francisco

Who can join

18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a pilot clinical study of hyperpolarized pyruvate (13C) injection that includes the acquisition of magnetic resonance (MR) data and will be performed in men with localized prostate cancer. Part 1: Five patients will be evaluated for reproducibility of 13C HP MR imaging measurements obtained 2-3 weeks apart with no interim treatment. Part 2: Five patients will be evaluated for the change in 13C HP MR imaging measurements after 2 months of ADT.

13C HP MR data will be acquired in two parts of the study (which can occur simultaneously): Part 1: Patients will undergo imaging at baseline and will be repeated two to three weeks later (with no intervention in the interim) to evaluate reproducibility.

Part 2: Patients will undergo imaging at baseline, initiate androgen deprivation therapy, and undergo repeat imaging two months after initiation of ADT to evaluate the ability of the imaging to reflect a metabolic response to treatment.

The change in pyruvate/lactate ratio and lactate levels will be measured and compared to baseline at these timepoints.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Magnetic resonance imaging with hyperpolarized agents: methods and applications.
   Adamson EB, Ludwig KD, Mummy DG, Fain SB. · · 2017 · cited 32× · PMID 28384123 · DOI 10.1088/1361-6560/aa6be8
2. Metabolic response to radiation therapy in cancer.
   Read GH, Bailleul J, Vlashi E, Kesarwala AH. · · 2022 · cited 25× · PMID 34961986 · DOI 10.1002/mc.23379