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Search / Trial NCT07115277

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

Launched by SINOTAU PHARMACEUTICAL GROUP · Aug 4, 2025

Trial Information

Current as of August 19, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called Flotufolastat F-18 PET, which helps doctors find where prostate cancer might have come back after treatment. The goal is to see how well this test works in detecting signs of prostate cancer returning, and to make sure it is safe for patients. This is especially important for men who have rising PSA levels—a blood marker that can suggest the cancer is back—after treatments like surgery, radiation, or other therapies.

Men who are 18 or older and have had previous prostate cancer treatments may be able to join the study if their PSA levels meet certain criteria showing possible cancer return. Participants will receive an injection of Flotufolastat F-18 and then have a PET/CT scan, which creates detailed images inside the body. If the scan finds suspicious areas, patients might be asked to have further tests to confirm the results. The study is currently looking for eligible men and includes safety checks to make sure the test is appropriate for each person. Overall, this trial aims to improve how prostate cancer recurrence is detected, which can help guide better treatment decisions.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Fully understand the study and voluntarily sign the informed consent form. 2. Male, aged ≥18 years. 3. Has previously received one or more of the following treatments:
  • 1. Radical prostatectomy (RP);
  • 2. RP with adjuvant radiotherapy (RT);
  • 3. RP with adjuvant androgen deprivation therapy (ADT);
  • 4. 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:
  • 1. After RP with or without adjuvant or salvage therapy: PSA≥ 0.2 ng/mL, and subsequent confirmation that PSA ≥ 0.2 ng/mL.
  • 2. After RT as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
  • 3. 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.
  • Exclusion Criteria:
  • 1. Planned to receive an X-ray contrast agent or other radioactive imaging agent within 24 hours before XTR020 PET imaging.
  • 2. 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).
  • 3. Known allergy to the active ingredient or any excipient of XTR020.
  • 4. Claustrophobia or inability to tolerate imaging examinations for any other reason.
  • 5. Poor compliance or deemed unsuitable for participation in this study by the investigator.
  • 6. Any condition that, in the opinion of the investigator, may interfere with data collection or prevent the study requirements.

About Sinotau Pharmaceutical Group

Sinotau Pharmaceutical Group is a leading biopharmaceutical company dedicated to the research, development, and commercialization of innovative therapies for serious health conditions. With a strong focus on advancing healthcare through cutting-edge science, Sinotau specializes in areas such as oncology, autoimmune diseases, and central nervous system disorders. The company prides itself on its commitment to clinical excellence and patient-centric solutions, leveraging a robust pipeline of novel compounds to address unmet medical needs globally. Through strategic partnerships and a dedication to quality, Sinotau aims to enhance patient outcomes and contribute to the advancement of global health.

Locations

Beijing, Beijing Shi, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported