Clinical Trial · NCT03698370

Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer

Overview

This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing participants with prostate cancer that has come back. Diagnostic procedures, such as gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread.

Sponsor

Stanford University

Phase

Phase 2

Contacts

Andrei Iagaru (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03698370

Drug / Compound

DOTA-NeoBOMB1

Isotope(s):

Target(s):

GRPR

Ligand Class: Peptides

Chelator: DOTA

PSMA-R2

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: DOTA

Linker: C6 (6-aminohexanoic acid)

Eligibility

Inclusion

Biopsy proven prostate adenocarcinoma.
Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). a. Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation. (i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy.(ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL).b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition.(i) A rise of PSA measurement of 2 or more ng/mL over the nadir.
Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent).

Exclusion

Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).