Prostate CancerPhase 3NCT06011304
Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer
A Phase 3 study testing [18F]Florastamin 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 at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging. This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry). 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?
- [18F]Florastamin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2023to 16 Apr 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 subjects aged 18 or older.
- Subjects with histopathological diagnosis of prostate adenocarcinoma.
- According to clinical judgment, radical prostatectomy and pelvic lymph node dissection (which can include patients with localized, regional lymph node metastasis or oligometastatic prostate cancer) are planned, and there is no surgical contraindication.
- If it is localized prostate cancer, according to the Prostate Cancer Diagnosis and Treatment Guidelines of 2021 Chinese Society of Clinical Oncology, it is necessary to meet any of the following criteria:
- Intermediate Risk: Has at least one intermediate risk factor: T2b-T2c; Gleason pattern 2 or 3; PSA 10-20 ng/mL, and does not include feature of high-risk or very-high-risk groups.
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- High Risk: Has no very-high-risk features and has at least one high-risk feature: T3a; Gleason Grade Group 4 or 5; PSA >20 ng/mL.
- Very High Risk: Has at least one of the following: T3b-T4; Primary Gleason pattern 5; More than 4 punctures with Gleason Grade Group 4 or 5.
- ECOG score 0 or 1.
- Subjects who meet the following conditions in hematology, renal function, and liver function:
- Platelet count>100 * 10^9/L
- 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 within 1 year 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.
- Patients with prior androgen deprivation therapy or any other neoadjuvant agent.
- 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, Open-Label, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer
In this study, 18F-Florastamin PET/CT will be performed in patients with at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.
This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).
- Conditions
- Prostate Cancer
- Being tested
- [18F]Florastamin 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.
[18F]Florastamin InjectionDrug
The subjects who participate in phase 3 study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 110 min after the injection.
Subjects who participate in pilot study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 5 min, 30 min, 60 min, 110 min, 160 min after the injection.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Florastamin Injection | Experimental | Not described Receives: Drug: [18F]Florastamin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity
The specificity of 18F-Florastamin PET/CT in patients with negative pelvic lymph node metastasis compared with the histopathology.
The subjects underwent RP (radical prostatectomy) with PLND (pelvic lymph node dissection) within 28 days after the administration of 18F-Florastamin Injection. The histopathology results of the pelvic lymph node tissue collected from the subjects will be used as the standard of truth for this study.
Measured: Within 28 days following 18F-Florastamin PET/CT
Secondary outcomes (1)
Sensitivity
The sensitivity of 18F-Florastamin PET/CT in patients with positive pelvic lymph node metastasis compared with the histopathology.
Measured: Within 28 days following 18F-Florastamin PET/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start20 Oct 2023
- Primary completion16 Apr 2026
- Study completion16 Apr 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
- 287 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
- NCT06011304
- Sponsor's protocol ID
- BJK-ZX-STM-2202-GK
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2023
- Last updated
- 29 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open-Label, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT06011304
- Acronym / sponsor ID
- BJK-ZX-STM-2202-GK
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- HTA Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 25 Aug 2023 (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 at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.
This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).
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: [18F]Florastamin Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
- Male subjects aged 18 or older.
- Subjects with histopathological diagnosis of prostate adenocarcinoma.
- According to clinical judgment, radical prostatectomy and pelvic lymph node dissection (which can include patients with localized, regional lymph node metastasis or oligometastatic prostate cancer) are planned, and there is no surgical contraindication.
- If it is localized prostate cancer, according to the Prostate Cancer Diagnosis and Treatment Guidelines of 2021 Chinese Society of Clinical Oncology, it is necessary to meet any of the following criteria:
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 within 1 year 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.
- Patients with prior androgen deprivation therapy or any other neoadjuvant agent.
- 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 |
|---|---|---|
| [18F]Florastamin InjectionThe subjects who participate in phase 3 study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 110 min after the injection. Subjects who participate in pilot study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 5 min, 30 min, 60 min, 110 min, 160 min after the injection. | Drug | 18F-Florastamin Injection |
Primary outcome
Specificity
Time frame: Within 28 days following 18F-Florastamin PET/CT
The specificity of 18F-Florastamin PET/CT in patients with negative pelvic lymph node metastasis compared with the histopathology. The subjects underwent RP (radical prostatectomy) with PLND (pelvic lymph node dissection) within 28 days after the administration of 18F-Florastamin Injection. The histopathology results of the pelvic lymph node tissue collected from the subjects will be used as the standard of truth for this study.
1 secondary outcome
Sensitivity
Time frame: Within 28 days following 18F-Florastamin PET/CT
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 29 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 [18F]Florastamin 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 15 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 29 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?
Specificity (time frame: Within 28 days following 18F-Florastamin PET/CT). 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 29 Sep 2026.