NCT05851365 is a EARLY_PHASE1 clinical trial of Hyperpolarized Bicarbonate (13C) in Prostate Cancer, sponsored by Robert Flavell, MD, PhD.

Who is sponsoring NCT05851365?

NCT05851365 is sponsored by Robert Flavell, MD, PhD.

What drugs are being tested in NCT05851365?

Interventions in NCT05851365: Hyperpolarized Bicarbonate (13C), Magnetic Resonance imaging.

What condition does NCT05851365 study?

NCT05851365 studies Prostate Cancer, Localized Prostate Carcinoma.

Is NCT05851365 still recruiting?

NCT05851365 is currently active, enrolled. Last updated 8 May 2025.

Last reviewed 2025-05-08 · How we verify

NCT05851365

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer

Active, enrolled EARLY_PHASE1 Last updated 8 May 2025

What this trial tests

EARLY_PHASE1 trial testing Hyperpolarized Bicarbonate (13C) in Prostate Cancer in 1 participant. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 July 2023

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	Robert Flavell, MD, PhD
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	1
Start date	6 July 2023
Primary completion	31 December 2025
Estimated completion	31 December 2025
Sites	1 location across United States

Drugs / interventions tested

Hyperpolarized Bicarbonate (13C) — full drug profile →
Magnetic Resonance imaging

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →
Localized Prostate Carcinoma — all drugs for Localized Prostate Carcinoma →

Sponsor

Robert Flavell, MD, PhD — full company profile →

Who can join

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

Sponsor's own description

This is a single site, prospective pilot study to determine the feasibility and safety of the administration of HP 13C bicarbonate in 10 patients with prostate cancer to determine potential hydrogen (pH) values in surrounding tissue. The proposed study will evaluate pre-surgical participants with histologically confirmed localized prostate cancer who receive infusion of hyperpolarized 13C injection prior to MR imaging with endorectal coil.

Publications & conference data

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

Clinically Translatable Hyperpolarized <sup>13</sup>C Bicarbonate pH Imaging Method for Use in Prostate Cancer.
Mu C, Liu X, Kim Y, Riselli A, et al · · 2023 · cited 10× · PMID 37878761 · DOI 10.1021/acssensors.3c00851
An Update on MR Spectroscopy in Cancer Management: Advances in Instrumentation, Acquisition, and Analysis.
Martinez Luque E, Liu Z, Sung D, Goldberg RM, et al · · 2024 · cited 8× · PMID 38578207 · DOI 10.1148/rycan.230101
Protocol for producing hyperpolarized <sup>13</sup>C-bicarbonate for clinical MRI of extracellular pH in aggressive tumors.
Mu C, Liu X, Riselli A, Slater J, et al · · 2024 · cited 1× · PMID 38943645 · DOI 10.1016/j.xpro.2024.103091
Hyperpolarized MRI theranostics in cancer.
Yamashita K, Zhao Z, Saito K, Takakusagi Y. · · 2025 · PMID 41306524 · DOI 10.3389/fonc.2025.1693853

Verify or expand the search:

Other recruiting trials for Prostate Cancer

Currently open trials in the same condition.

NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting

Other Robert Flavell, MD, PhD trials

Trials by the same sponsor.

NCT06894745 — PET [89Zr]DFO-starPEG in Solid Tumors · Phase 1 · recruiting
NCT05892393 — Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma · Phase 1 · recruiting
NCT05245006 — PET Imaging Study of 89Zr-DFO-YS5 in Men With Prostate Cancer · Phase 1 · active not recruiting
NCT03546335 — Zr-89 Cimzia PET Imaging Rheumatoid Arthritis · Phase 1 · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05851365 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Robert Flavell, MD, PhD
Last refreshed: 8 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05851365.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing