Flotufolastat F-18 PET scan to find recurrent prostate cancer

A Single-arm, Multicenter, Phase III Clinical Trial , Evaluate the Diagnostic Performance and Safety of Flotufolastat F-18 Injection PET Imaging in Prostate Cancer Subjects With Biochemical Recurrence Following Prior Treatment

This will test whether a Flotufolastat F-18 PET scan can find prostate cancer that has come back in men with rising PSA after prior treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 121 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Sinotau Pharmaceutical Group (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07115277 on ClinicalTrials.gov

What this trial studies

Men with biochemical recurrence after prostatectomy, radiotherapy, or focal therapy receive an injection of Flotufolastat F-18 followed by PET/CT imaging to identify sites of recurrent disease. Images will be read visually and compared to a truth standard, which may include histopathology or conventional imaging, to determine the correct detection rate. Safety of the tracer will be monitored through adverse event reporting. The study is conducted at Chinese PLA General Hospital and asks participants to agree to confirmation (for example, biopsy) if positive lesions are seen.

Who should consider this trial

Good fit: Men aged 18 or older with biochemical recurrence by the trial's PSA criteria after prior prostatectomy, radiotherapy, or focal gland therapy who are willing to have follow-up confirmation of positive findings.

Not a fit: Patients without a confirmed PSA rise, those unwilling to undergo additional confirmation such as biopsy, or those with contraindications to PET/CT are unlikely to receive benefit from this imaging test.

Why it matters

Potential benefit: If successful, the scan could find recurrent prostate cancer earlier and more accurately, helping doctors target salvage treatments.

How similar studies have performed: Other PSMA-targeted PET tracers have shown improved detection rates in biochemical recurrence, so similar imaging approaches have demonstrated clinical usefulness.

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.

Where this trial is running

Beijing, Beijing Municipality

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Ruimin Wang, Doctor

Conditions Prostate Cancer