Prostate CancerEarly Phase 1NCT06756334
Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in PCa Diagnosis, Recurrence, and Metastasis
A Early Phase 1 study testing [18F]AlF-PSMA-N5 and [18F]F-DCFPyL in people with Prostate Cancer and PET/CT, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [18F]AlF-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [18F]F-DCFPyL. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, PET/CT
- What is being tested?
- [18F]AlF-PSMA-N5 and [18F]F-DCFPyL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2024to 31 Dec 2025
- Phase
- Early Phase 1
- 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 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged from 18 to 90 years old;
- Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
- Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
- simultaneous [18F]AlF-PSMA-N5 and [18F]F-DCFPyL examinations within two weeks;
- Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
- Sign informed consent.
Who cannot join
- Patients who cannot cooperate with the examination;
- Concurrent malignant tumors;
- Previous alcohol allergy;
- Patients with liver and kidney dysfunction;
- Other circumstances deemed by the investigator to be inappropriate for trial participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
Hefei, Anhui, 230000
Qiang Xie, MD, 13721108043, xieqiang1980@ustc.edu.cn
About this study
Official title: Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [18F]AlF-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [18F]F-DCFPyL.
Read the detailed description
[18F]AlF-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [18F]F-DCFPyL PET/CT.
- Conditions
- Prostate Cancer, PET/CT
- Being tested
- [18F]AlF-PSMA-N5, [18F]F-DCFPyL
- 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]AlF-PSMA-N5Drug
Each subject receive a single intravenous injection of [18F]AlF-PSMA-N5, and undergo PET/CT imaging within the specificed time.
[18F]F-DCFPyLDrug
Each subject receive a single intravenous injection of [18F]F-DCFPyL, and undergo PET/CT imaging within the specificed time.
| Study group | Role | What they receive |
|---|---|---|
| [18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan | Experimental | Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of [18F]AlF-PSMA-N5 and [18F]F-DCFPyL. Receives: Drug: [18F]AlF-PSMA-N5; Drug: [18F]F-DCFPyL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard uptake value(SUV)
Standard uptake value(SUV) of [18F]AlF-PSMA-N5 and [18F]F-DCFPyL for each target lesion of subjects.
Measured: 30 days
Secondary outcomes (2)
Diagnostic efficacy
The sensitivity, specificity and accuracy of [18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/CT were calculated.
Measured: 30 days
Number of lesions
The number of lesions detected by [18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/CT.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start19 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Qiang Xie, MD, Study chair, The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756334
- Sponsor's protocol ID
- PSMA PET STUDY -03
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-to-head Comparison of [18F]AlF-PSMA-N5 With [18F]F-DCFPyL PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study
- ClinicalTrials.gov ID
- NCT06756334
- Acronym / sponsor ID
- PSMA PET STUDY -03
- Conditions
- Prostate Cancer, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jan 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.
To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent [18F]AlF-PSMA-N5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with [18F]F-DCFPyL.
Detailed description
[18F]AlF-PSMA-N5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of [18F]F-DCFPyL PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan | Experimental | Drug: [18F]AlF-PSMA-N5, Drug: [18F]F-DCFPyLSubjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of [18F]AlF-PSMA-N5 and [18F]F-DCFPyL. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged from 18 to 90 years old;
- Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
- Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
- simultaneous [18F]AlF-PSMA-N5 and [18F]F-DCFPyL examinations within two weeks;
- Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
Key exclusion criteria (5 listed)
- Patients who cannot cooperate with the examination;
- Concurrent malignant tumors;
- Previous alcohol allergy;
- Patients with liver and kidney dysfunction;
- Other circumstances deemed by the investigator to be inappropriate for trial participation.
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]AlF-PSMA-N5Each subject receive a single intravenous injection of [18F]AlF-PSMA-N5, and undergo PET/CT imaging within the specificed time. | Drug | [18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan |
| [18F]F-DCFPyLEach subject receive a single intravenous injection of [18F]F-DCFPyL, and undergo PET/CT imaging within the specificed time. | Drug | [18F]AlF-PSMA-N5 and [18F]F-DCFPyL PET/ CT scan |
Primary outcome
Standard uptake value(SUV)
Time frame: 30 days
Standard uptake value(SUV) of [18F]AlF-PSMA-N5 and [18F]F-DCFPyL for each target lesion of subjects.
2 secondary outcomes
Diagnostic efficacy
Time frame: 30 days
Number of lesions
Time frame: 30 days
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 3 Jan 2025.
- 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.
Qiang Xie, MD study chair
The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18F]AlF-PSMA-N5 and [18F]F-DCFPyL in people with Prostate Cancer and PET/CT, run by Anhui Provincial Hospital 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 6 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: looking for participants now, as of the sponsor's last update on 3 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Qiang Xie, MD (13721108043, xieqiang1980@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard uptake value(SUV) (time frame: 30 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 3 Jan 2025.