Prostate CancerPhase 3NCT06754085
Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
A Phase 3 study testing Florastamin[18F] Injection in people with Prostate Cancer, run by HTA Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Florastamin[18F] Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2024to 11 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
- Male ≥ 18 years of age.
- Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.
- Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions:
- 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
- Post-radiation therapy, after radical radiotherapy (or cryoablation therapy): Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir .
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- Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment;
- ECOG score 0 or 2.
- 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.
- Expected survival time ≥ 6 months.
- Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration.
Who cannot join
- 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.
- 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.
- Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration.
- If previously taking ADT, it should have been discontinued at least 16 weeks prior to study drug administration.
- The investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Prospective, Open-Label, Single-Arm, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
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.
- Conditions
- Prostate Cancer
- Being tested
- Florastamin[18F] Injection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florastamin[18F] InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Florastamin Injection | Experimental | Not described Receives: Drug: Florastamin[18F] Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Positive Predictive Value of 18F-Florastamin PET/CT in patients with suspected recurrence of prostate cancer on a patient-level.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start19 Dec 2024
- Primary completion11 Jun 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- HTA Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754085
- Sponsor's protocol ID
- BJK-ZX-STM-2203-GK
- Status last verified
- Sep 2026
- First submitted
- 23 Dec 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Prospective, Open-Label, Single-Arm, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
- ClinicalTrials.gov ID
- NCT06754085
- Acronym / sponsor ID
- BJK-ZX-STM-2203-GK
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- HTA Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 11 Jun 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-Florastamin Injection | Experimental | Drug: Florastamin[18F] Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
- Male ≥ 18 years of age.
- Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.
- Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions:
- Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment;
Key exclusion criteria (5 listed)
- 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.
- 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.
- Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration.
- If previously taking ADT, it should have been discontinued at least 16 weeks prior to study drug administration.
- The investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Florastamin[18F] InjectionThe 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. | Drug | 18F-Florastamin Injection |
Primary outcome
The Positive Predictive Value of 18F-Florastamin PET/CT in patients with suspected recurrence of prostate cancer on a patient-level.
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Florastamin[18F] Injection in people with Prostate Cancer, run by HTA Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Positive Predictive Value of 18F-Florastamin PET/CT in patients with suspected recurrence of prostate cancer on a patient-level. (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.