TheranosticTrials.org

Clinical Trial · NCT07115277

Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer

Overview

The goal of this clinical trial is to evaluate the diagnostic performance and safety of Flotufolastat F-18 injection PET imaging in prostate cancer subjects with biochemical recurrence following prior treatment. The main question it aims to answer is: • What is the correct detection rate of Flotufolastat F 18 injection PET visual reading results compared to the truth standard? Participants will: * Receive Flotufolastat F-18 injection * Undergo PET/CT scanning

Sponsor

Sinotau Pharmaceutical Group

Phase

N/A

Contacts

Ruimin Wang, Doctor (CONTACT)

wrm@yeah.net

010-66938008

ClinicalTrials.gov

NCT07115277

Drug / Compound

Flotufolastat

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

Eligibility

Inclusion

  • RP with adjuvant radiotherapy (RT);
  • After RT as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
  • RP with adjuvant androgen deprivation therapy (ADT);
  • After focal gland therapy as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir. 5\. If positive lesions are detected on the XTR020 PET imaging or conventional imaging, the subject is willing to receive histopathological confirmation or the sequqnce of conventional imaging confirmation. 6\. Male subjects with reproductive potential must use effective contraception during the study period and 6 months after the study completed; their partners should agree to use contraception during the study period and 6 months after the study completed , too.
  • Radical prostatectomy (RP);
  • After RP with or without adjuvant or salvage therapy: PSA≥ 0.2 ng/mL, and subsequent confirmation that PSA ≥ 0.2 ng/mL.
  • Radical RT or focal gland therapy (e.g., brachytherapy, high-intensity focused ultrasound \[HIFU\]). 4\. Clinically suspected BCR, serum PSA levels should meet at least one of the followings:

Exclusion

  • Known allergy to the active ingredient or any excipient of XTR020.
  • Poor compliance or deemed unsuitable for participation in this study by the investigator.
  • Claustrophobia or inability to tolerate imaging examinations for any other reason.
  • Participation in an interventional clinical trial involving a new drug or treatment within 30 days or 5 biological half-lives of the drug prior to XTR020 PET imaging (whichever is longer).
  • Any condition that, in the opinion of the investigator, may interfere with data collection or prevent the study requirements.
  • Planned to receive an X-ray contrast agent or other radioactive imaging agent within 24 hours before XTR020 PET imaging.