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Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

NCT ID: NCT06754085

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-19

Study Completion Date

2026-05-01

Brief Summary

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In this study, 18F-Florastamin PET/CT will be performed in patients with suspected recurrence of prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-Florastamin Injection

Group Type EXPERIMENTAL

Florastamin[18F] Injection

Intervention Type DRUG

The subjects will be intravenously injected with a single dose of 7±1 mCi (259±37 MBq) of Florastamin\[18F\] Injection and undergo PET/CT scan at 60-110 min after the injection.

Interventions

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Florastamin[18F] Injection

The subjects will be intravenously injected with a single dose of 7±1 mCi (259±37 MBq) of Florastamin\[18F\] Injection and undergo PET/CT scan at 60-110 min after the injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
2. Male ≥ 18 years of age.
3. Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.
4. Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions:

1. At least 6 weeks after radical prostatectomy (RP): PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL.; or
2. Post-radiation therapy, after radical radiotherapy (or cryoablation therapy): Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir .
5. Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment;
6. ECOG score 0 or 2.
7. Subjects who meet the following conditions in hematology, renal function, and liver function:

Platelet count\>50 \* 10\^9/L Urea/urea nitrogen and creatinine\<1.5 times upper limits of normal AST and ALT\<2.5 times upper limits of normal.
8. Expected survival time ≥ 6 months.
9. Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration.

Exclusion Criteria

1. Subjects who have participated in other interventional clinical trials before signing ICF and were within the 5 half-lives of the investigational drug, or who are currently participating in other interventional clinical trials or have participated in clinical trials of radioactive drugs before signing ICF and have been discontinued for less than 3 months until the signing date of ICF.
2. Intravenous injection of iodinated contrast medium within 24 hours, or any high-density oral contrast medium (Such as barium sulfate. Oral water contrast is acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior to study drug administration.
3. Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration.
4. If previously taking ADT, it should have been discontinued at least 16 weeks prior to study drug administration.
5. The investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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HTA Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Fan

Role: CONTACT

Phone: +86 13602883007

Email: [email protected]

Facility Contacts

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Wei Fan

Role: primary

Other Identifiers

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BJK-ZX-STM-2203-GK

Identifier Type: -

Identifier Source: org_study_id