Clinical Trial · NCT04158817

68Ga-THP-PSMA PET/CT in Prostate Cancer: Clinical Stage and Restage

Overview

To evaluate the dosimetry, safety and the detection rate of 68Ga-THP-PSMA PET/CT for identifying the site of prostate cancer metastasis and relapse. It is also to evaluate the association of clinical/pathologic features and 68Ga-THP-PSMA PET/CT detection rate and compare 68Ga-THP-PSMA PET/CT with other imaging procedure.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Phase

Early Phase 1

Contacts

Jinhua Zhao, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04158817

Drug / Compound

THP-PSMA

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Chelator: THP

Eligibility

Inclusion

Prior diagnosis of prostatic cancer

Exclusion

Abnormal liver function during baseline screening period: AST or ALT\> 2 times the upper limit of normal value (ULN), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. Once, if more than 2 times ULN after retesting, consider enrolling).
Impaired renal function during screening: serum creatinine or urea nitrogen \> 1.5 times ULN.
Within 4 months prior to the baseline screening period, myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive Heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above II)