TheranosticTrials.org

Clinical Trial · NCT05516329

Study of 18F-Thretide PET/CT in Patients With Prostate Cancer

Overview

This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

Sponsor

First Affiliated Hospital of Fujian Medical University

Phase

Phase 1/2

ClinicalTrials.gov

NCT05516329

Drug / Compound

Thretide

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • For patients with suspected recurrence of prostate cancer: (1)Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy; (2)Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of: Post-radical prostatectomy: Detectable or rising PSA level ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL ; or Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir;
  • Life expectancy ≥3 months as determined by the investigator;
  • For patients with newly diagnosed prostate cancer : (1) adult patients with PCa confirmed by biopsy; (2) no any form of therapy against PCa within last three months; (3) planned surgical treatment;

Exclusion

  • Patients receiving ADT treatment or chemotherapy;
  • Serious diseases of the heart, kidney, lung, vascular, nervous and psychiatric systems, immune deficiency diseases and hepatitis/cirrhosis;
  • Patients who participated in clinical trials of radiopharmaceuticals within the previous 1 year;
  • Patients who cannot tolerate intravenous administration (such as a history of needle sickness or blood sickness);
  • Participated in other interventional clinical trials within 1 month prior to screening;
  • Those who are not suitable for or unable to complete PET or other imaging examinations due to special reasons, including claustrophobia and radiophobia, etc.
  • There are other conditions that the researcher considers inappropriate to participate in this study.
  • Practitioners requiring prolonged exposure to radioactive conditions;
  • Known allergic history to fluoride 18F-Thretide injection and/or 99mTc-MDP or its excipients;
  • Have been diagnosed with clinical recurrence of prostate cancer;