Prostate CAPhase 1/2NCT07056790
Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer
A Phase 1/2 study testing 68Ga-PSMA-CYC and CYC in people with Prostate CA, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
68Ga-PSMA-CYC is a novel radiotracer targeting PSMA. In this study, we investigated the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate CA
- What is being tested?
- 68Ga-PSMA-CYC and CYC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to May 2027
- Phase
- Phase 1/2
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed treated or untreated prostate cancer patients;
- signed written consent.
Who cannot join
- known allergy against PSMA;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
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 Fujian Medical University
Fuzhou, Fujian, 350005
weibing miao, MD, +86-0591-87981618, miaoweibing@126.com
Jie Zang, MD, 15901495106, 15901495106@163.com
About this study
68Ga-PSMA-CYC is a novel radiotracer targeting PSMA. In this study, we investigated the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.
Read the detailed description
Prostate cancer (PCa) is one of the most common malignant tumors among men worldwide. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein that is highly expressed in PCa and its metastatic lesions, making it an ideal target for the precise diagnosis and treatment of PCa. Various low-molecular-weight radiopharmaceuticals targeting PSMA have been developed, such as PSMA-11 and PSMA-617, which can be labeled with 68Ga or 177Lu. 68Ga-PSMA-CYC is a novel radiotracer that has demonstrated favorable in vivo and in vitro stability in preliminary studies, with specific accumulation in PCa, high binding affinity, and good safety profile, making it a promising candidate for further investigation. This prospective study aims to investigate the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.
- Conditions
- Prostate CA
- Being tested
- 68Ga-PSMA-CYC, CYC
- Keywords
- psma, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMA-CYCDrug
Each prostate cancer patient underwent a 68Ga-PSMA-CYC (3-4 mCi) PET/CT scan, as well as a 68Ga-PSMA-617 (3-4 mCi) or 68Ga-PSMA-11 (3-4 mCi) PET/CT scan, with the time interval between the two scans not exceeding one week.
CYCDrug
The dose will be 3-4mCi given intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Patients will undergo a 68Ga-PSMA-CYC PET/CT 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT | Active comparator | Prostate Patients received 68Ga-PSMA-CYC 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT imaging within one week. Tracer doses of 68Ga-PSMA-CYC、68Ga-PSMA-617 or 68Ga-PSMA-11 will be used to image lesions of prostate cancer by PET/CT Receives: Drug: 68Ga-PSMA-CYC |
| 68Ga-PSMA-CYC | Experimental | Experimental: dynamic PET scans PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection Receives: Drug: CYC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and Specificity of 68Ga-PSMA-CYC for prostate cancer in comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 PET/CT.
Measured: through study completion, an average of 1year
Adverse events
The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Measured: Within 7 days following PET/CT
Secondary outcomes (1)
Dosimetry data
Calculate the absorbed dose of 68Ga-PSMAcyc in normal organs.
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start15 May 2025
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CAStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056790
- Sponsor's protocol ID
- FAHFJ-68Ga-PSMAcyc
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 9 Jul 2025
- 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 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer
- ClinicalTrials.gov ID
- NCT07056790
- Acronym / sponsor ID
- FAHFJ-68Ga-PSMAcyc
- Conditions
- Prostate CA
- Keywords
- psma, prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Jul 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.
68Ga-PSMA-CYC is a novel radiotracer targeting PSMA. In this study, we investigated the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.
Detailed description
Prostate cancer (PCa) is one of the most common malignant tumors among men worldwide. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein that is highly expressed in PCa and its metastatic lesions, making it an ideal target for the precise diagnosis and treatment of PCa. Various low-molecular-weight radiopharmaceuticals targeting PSMA have been developed, such as PSMA-11 and PSMA-617, which can be labeled with 68Ga or 177Lu. 68Ga-PSMA-CYC is a novel radiotracer that has demonstrated favorable in vivo and in vitro stability in preliminary studies, with specific accumulation in PCa, high binding affinity, and good safety profile, making it a promising candidate for further investigation. This prospective study aims to investigate the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients will undergo a 68Ga-PSMA-CYC PET/CT 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT | Active comparator | Drug: 68Ga-PSMA-CYCProstate Patients received 68Ga-PSMA-CYC 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT imaging within one week. Tracer doses of 68Ga-PSMA-CYC、68Ga-PSMA-617 or 68Ga-PSMA-11 will be used to image lesions of prostate cancer by PET/CT |
| 68Ga-PSMA-CYC | Experimental | Drug: CYCExperimental: dynamic PET scans PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- confirmed treated or untreated prostate cancer patients;
- signed written consent.
Key exclusion criteria (2 listed)
- known allergy against PSMA;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
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 |
|---|---|---|
| 68Ga-PSMA-CYCEach prostate cancer patient underwent a 68Ga-PSMA-CYC (3-4 mCi) PET/CT scan, as well as a 68Ga-PSMA-617 (3-4 mCi) or 68Ga-PSMA-11 (3-4 mCi) PET/CT scan, with the time interval between the two scans not exceeding one week. | Drug | Patients will undergo a 68Ga-PSMA-CYC PET/CT 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT |
| CYCThe dose will be 3-4mCi given intravenously. | Drug | 68Ga-PSMA-CYC |
Primary outcome
Diagnostic value
Time frame: through study completion, an average of 1year
Sensitivity and Specificity of 68Ga-PSMA-CYC for prostate cancer in comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 PET/CT.
Adverse events
Time frame: Within 7 days following PET/CT
The safety will be assessed by the number and percentage of patients with adverse events; Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
1 secondary outcome
Dosimetry data
Time frame: through study completion, an average of 3 months
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 9 Jul 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.
Weibing Miao, MD principal investigator
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-PSMA-CYC and CYC in people with Prostate CA, run by First Affiliated Hospital of Fujian Medical 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 2 inclusion and 2 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 9 Jul 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Weibing Miao, MD (059187981618, miaoweibing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value (time frame: through study completion, an average of 1year). The study lists 2 primary outcomes in all. 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 9 Jul 2025.