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

NCT07115277 | Recruiting

• 1 other identifier: XTR020-301
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with biochemical recurrence (BCR)

  Correct Detection Rate (CDR) at the individual level of Flotufolastat F-18 Injection PET imaging in prostate cancer subjects with BCR

  90 days

Secondary Outcomes (4)

• To evaluate other diagnostic performance parameters of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with BCR

  90 days

• To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in different subgroups of Chinese prostate cancer subjects with BCR

  90 days

• To evaluate inter-reader and intra-reader interpretative consistency among independent blinded readers.

  90 days

• To evaluate the safety of Flotufolastat F-18 Injection .

  3 days

Study Arms (1)

All prostate cancer subjects will undergo PET imaging using Flotufolastat F-18 Injection

EXPERIMENTAL

Drug: Flotufolastat F-18 Injection

Interventions

Flotufolastat F-18 Injection DRUG

All patients will receive one injection of Flotufolastat F-18 Injection, a PET radiopharmaceutical selective for PSMA. For the injection, subjects will receive a target dose of 8 mCi (296 MBq) ± 20% IV as a bolus injection. Flotufolastat F-18 Injection will be followed by a 10 ml saline flush.

All prostate cancer subjects will undergo PET imaging using Flotufolastat F-18 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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:
• 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 \[HIFU\]).
• \. Clinically suspected BCR, serum PSA levels should meet at least one of the followings:
• After RP with or without adjuvant or salvage therapy: PSA≥ 0.2 ng/mL, and subsequent confirmation that PSA ≥ 0.2 ng/mL.
• After RT as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
• After focal gland therapy as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
• \. 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.
• \. 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.

You may not qualify if:

• 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.
• Poor compliance or deemed unsuitable for participation in this study by the investigator.
• Any condition that, in the opinion of the investigator, may interfere with data collection or prevent the study requirements.

Sponsors & Collaborators

• Sinotau Pharmaceutical Group: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100089, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Ruimin Wang, Doctor

CONTACT

010-66938008; wrm@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)