Prostate CancerNCT06723665
The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients
A study testing 18F-PSMA-1007 and 18F-FDG in people with Prostate Cancer, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
micro-PET imaging showed that 18F-PSMA-1007 had similar or even better pharmacokinetics and imaging performance than 18F-DCFPyL. Due to the convenience of synthesis and good imaging performance, 18F-PSMA-1007 is expected to be popularized in clinical practice.The purpose of this study is to evaluate the performance of… Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 18F-PSMA-1007 and 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostate cancer is clinically suspected. The patient was diagnosed with prostate cancer by biopsy. Prostate cancer needs to be evaluated after treatment.
Who cannot join
- Patients who did not meet the requirements as assessed by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
micro-PET imaging showed that 18F-PSMA-1007 had similar or even better pharmacokinetics and imaging performance than 18F-DCFPyL. Due to the convenience of synthesis and good imaging performance, 18F-PSMA-1007 is expected to be popularized in clinical practice.The purpose of this study is to evaluate the performance of 18F-PSMA-1007 in diagnosis, differential diagnosis and efficacy monitoring of prostate cancer.
Read the detailed description
- Visual analysis of images: describe the location, size, shape and degree of uptake of lesions;
- Semi-quantitative analysis: the ratio of lesion site uptake to liver uptake was measured by area of interest method (ROI);
- Comparative analysis: Compared with clinical routine 18F-FDG PET/CT imaging, the advantages of PSMA PET/CT imaging were clarified;
- Evaluation and analysis of efficacy: before and after treatment, to clarify the early treatment evaluation value of PSMA PET/CT imaging, and compare it with 18F-FDG PET/CT imaging;
- Prognostic study: Through multi-factor analysis, the relationship between the level of PSMA PET/CT imaging uptake and the prognosis of patients was clarified.
- Conditions
- Prostate Cancer
- Being tested
- 18F-PSMA-1007, 18F-FDG
- Keywords
- prostate cancer, PET/CT, PSMA-1007, 18F
- 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-PSMA-1007Drug
18F-PSMA-1007 is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg
18F-FDGDrug
18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg
| Study group | Role | What they receive |
|---|---|---|
| 18F-PSMA-1007 | Experimental | Subjects: Patients with suspected or diagnosed prostate cancer, or biochemical recurrence of prostate cancer.
Over 40 years old (including 40 years old); Informed consent and access to follow-up; To exclude patients who are difficult to receive further diagnosis and treatment because of their serious condition.
PSMA PET/CT was reviewed 7 days and 3 months after surgery. All patients were followed up once every 3 months to understand the progression and survival of the lesions. Receives: Drug: 18F-PSMA-1007 |
| 18F-FDG | Active comparator | The corresponding patients underwent PSMAPET/CT examination within one week before and after routine 18F-FDGPCT/CT imaging (control examination). PCT/CT whole body scan was performed 45min-1h after intravenous injection of the developer, and the image processing was as usual. Receives: Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-PSMA-1007 PET/CT and 18F-FDG PCT/CT imaging were compared to determine the advantages of 18F-PSMA-PSMA PET/CT imaging for prostate cancer
For patients receiving 18F-PSMA-1007 PET/CT, 18F-FDG PET/CT imaging was performed, and image visual analysis, semi-quantitative analysis and prognostic study were performed on PET/CT images. To evaluate the diagnosis, staging and prognosis of 18F-PSMA-1007
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start25 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723665
- Sponsor's protocol ID
- LS2024279
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06723665
- Acronym / sponsor ID
- LS2024279
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, PET/CT, PSMA-1007, 18F
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 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.
micro-PET imaging showed that 18F-PSMA-1007 had similar or even better pharmacokinetics and imaging performance than 18F-DCFPyL. Due to the convenience of synthesis and good imaging performance, 18F-PSMA-1007 is expected to be popularized in clinical practice.The purpose of this study is to evaluate the performance of 18F-PSMA-1007 in diagnosis, differential diagnosis and efficacy monitoring of prostate cancer.
Detailed description
- Visual analysis of images: describe the location, size, shape and degree of uptake of lesions;
- Semi-quantitative analysis: the ratio of lesion site uptake to liver uptake was measured by area of interest method (ROI);
- Comparative analysis: Compared with clinical routine 18F-FDG PET/CT imaging, the advantages of PSMA PET/CT imaging were clarified;
- Evaluation and analysis of efficacy: before and after treatment, to clarify the early treatment evaluation value of PSMA PET/CT imaging, and compare it with 18F-FDG PET/CT imaging;
- Prognostic study: Through multi-factor analysis, the relationship between the level of PSMA PET/CT imaging uptake and the prognosis of patients was clarified.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18F-PSMA-1007 | Experimental | Drug: 18F-PSMA-1007Subjects: Patients with suspected or diagnosed prostate cancer, or biochemical recurrence of prostate cancer. Over 40 years old (including 40 years old); Informed consent and access to follow-up; To exclude patients who are difficult to receive further diagnosis and treatment because of their serious condition. PSMA PET/CT was reviewed 7 days and 3 months after surgery. All patients were followed up once every 3 months to understand the progression and survival of the lesions. |
| 18F-FDG | Active comparator | Drug: 18F-FDGThe corresponding patients underwent PSMAPET/CT examination within one week before and after routine 18F-FDGPCT/CT imaging (control examination). PCT/CT whole body scan was performed 45min-1h after intravenous injection of the developer, and the image processing was as usual. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prostate cancer is clinically suspected. The patient was diagnosed with prostate cancer by biopsy. Prostate cancer needs to be evaluated after treatment.
Key exclusion criteria (1 listed)
- Patients who did not meet the requirements as assessed by the investigator.
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-PSMA-100718F-PSMA-1007 is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg | Drug | 18F-PSMA-1007 |
| 18F-FDG18F-FDG is administered through a superficial dorsal vein, and the patient is given a dose of about 0.1-0.15mCi/kg | Drug | 18F-FDG |
Primary outcome
18F-PSMA-1007 PET/CT and 18F-FDG PCT/CT imaging were compared to determine the advantages of 18F-PSMA-PSMA PET/CT imaging for prostate cancer
Time frame: 1 day
For patients receiving 18F-PSMA-1007 PET/CT, 18F-FDG PET/CT imaging was performed, and image visual analysis, semi-quantitative analysis and prognostic study were performed on PET/CT images. To evaluate the diagnosis, staging and prognosis of 18F-PSMA-1007
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
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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.
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 18F-PSMA-1007 and 18F-FDG in people with Prostate Cancer, run by Affiliated Hospital of Jiangnan University 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 24 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
18F-PSMA-1007 PET/CT and 18F-FDG PCT/CT imaging were compared to determine the advantages of 18F-PSMA-PSMA PET/CT imaging for prostate cancer (time frame: 1 day). 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 24 Jan 2025.