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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Flotufolastat F-18 Injection
  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.

Первичные конечные точки

• To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with biochemical recurrence (BCR) [Срок оценки: 90 days]

Вторичные конечные точки (4)

• To evaluate other diagnostic performance parameters of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with BCR [Срок оценки: 90 days]
• To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in different subgroups of Chinese prostate cancer subjects with BCR [Срок оценки: 90 days]
• To evaluate inter-reader and intra-reader interpretative consistency among independent blinded readers. [Срок оценки: 90 days]
• To evaluate the safety of Flotufolastat F-18 Injection . [Срок оценки: 3 days]

Критерии участия

Критерии включения

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:

• 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 \[HIFU\]).

4\. 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.

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07115277 · XTR020-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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