Prostate CancerNCT07115277
Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer
A study testing Flotufolastat F-18 Injection in people with Prostate Cancer, run by Sinotau Pharmaceutical Group at 1 site in China.
Trial 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. 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?
- Flotufolastat F-18 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2025to 27 Jan 2026
- Phase
- Interventional
- 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
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- Flotufolastat F-18 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.
Flotufolastat F-18 InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| All prostate cancer subjects will undergo PET imaging using Flotufolastat F-18 Injection | Experimental | Not described Receives: Drug: Flotufolastat F-18 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Positive predictive value (PPV) of Flotufolastat F-18 Injection PET imaging at the individual level in prostate cancer subjects with BCR.
PPV and CDR of Flotufolastat F-18 Injection PET imaging in the prostate bed, pelvic lymph nodes, and three other regions in Chinese prostate cancer subjects with BCR.
Measured: 90 days
To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in different subgroups of Chinese prostate cancer subjects with BCR
Individual-level PPV and CDR of Flotufolastat F-18 Injection PET imaging in subjects whose baseline conventional imaging is negative.
Individual-level PPV and CDR of Flotufolastat F-18 Injection PET imaging at different PSA levels.
Measured: 90 days
To evaluate inter-reader and intra-reader interpretative consistency among independent blinded readers.
Kappa values for inter-reader and intra-reader agreement in the interpretation of the same Flotufolastat F-18 Injection PET imaging by different independent blinded readers and by the same reader at different times.
Measured: 90 days
To evaluate the safety of Flotufolastat F-18 Injection .
The types, severity, frequency, and outcomes of adverse events/serious adverse events reported during the study period.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start19 Feb 2025
- Primary completion18 Dec 2025
- Study completion27 Jan 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115277
- Sponsor's protocol ID
- XTR020-301
- Status last verified
- Nov 2026
- First submitted
- 4 Aug 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07115277
- Acronym / sponsor ID
- XTR020-301
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 11 Aug 2025 (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.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All prostate cancer subjects will undergo PET imaging using Flotufolastat F-18 Injection | Experimental | Drug: Flotufolastat F-18 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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]).
Key exclusion criteria (6 listed)
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 |
|---|---|---|
| Flotufolastat F-18 InjectionAll 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. | Drug | All prostate cancer subjects will undergo PET imaging using Flotufolastat F-18 Injection |
Primary outcome
To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with biochemical recurrence (BCR)
Time frame: 90 days
Correct Detection Rate (CDR) at the individual level of Flotufolastat F-18 Injection PET imaging in prostate cancer subjects with BCR
4 secondary outcomes
To evaluate other diagnostic performance parameters of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with BCR
Time frame: 90 days
To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in different subgroups of Chinese prostate cancer subjects with BCR
Time frame: 90 days
To evaluate inter-reader and intra-reader interpretative consistency among independent blinded readers.
Time frame: 90 days
To evaluate the safety of Flotufolastat F-18 Injection .
Time frame: 3 days
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 6 Nov 2026.
- Individual participant dataSharing planned: No
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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 study testing Flotufolastat F-18 Injection in people with Prostate Cancer, run by Sinotau Pharmaceutical Group 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 11 inclusion and 6 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 6 Nov 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.
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?
To evaluate the diagnostic performance of Flotufolastat F-18 Injection PET imaging in Chinese prostate cancer subjects with biochemical recurrence (BCR) (time frame: 90 days). 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 6 Nov 2026.