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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorSinotau Pharmaceutical Group

About this trial

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

Eligibility criteria

Qualifiers

Radical prostatectomy (RP);

RP with adjuvant radiotherapy (RT);

RP with adjuvant androgen deprivation therapy (ADT);

Radical RT or focal gland therapy (e.g., brachytherapy, high-intensity focused ultrasound [HIFU]).

Disqualifiers

Planned to receive an X-ray contrast agent or other radioactive imaging agent within 24 hours before XTR020 PET imaging.

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).

Known allergy to the active ingredient or any excipient of XTR020.

Claustrophobia or inability to tolerate imaging examinations for any other reason.

Trial design

Treatments tested in this trial

  • Flotufolastat F-18 Injection

Treatment groups

121 Participants
are divided into 1 treatment group

Sponsors and collaborators