Clinical Trial · NCT04102553

F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence

Overview

This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.

Sponsor

Advanced Biochemical Compounds

Phase

Phase 3

ClinicalTrials.gov

NCT04102553

Drug / Compound

PSMA-1007

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after prostatectomy)
willing and able to undergo all study procedures
life expectancy of 6 months or more as judged by the investigator
male with original diagnosis of prostate carcinoma with prior definitive therapy

Exclusion

being considered a vulnerable person
close affiliation with the investigational site; e.g. first-degree relative of the investigator
contraindications for F-18-Fluorocholine
mental conditions rendering the subject incapable to understand the nature, scope, and consequences of the trial
being clinically unstable or requiring emergency treatment
at the time of enrolment into this study, participating in another therapeutic clinical trial or has completed study participation in another therapeutic clinical trial within 5 days of enrolment into this trial
contraindications for any of the ingredients of F-18-PSMA-1007
having been previously enrolled in this clinical trial