Prostate CancerPhase 1/2NCT05516329
Study of 18F-Thretide PET/CT in Patients With Prostate Cancer
A Phase 1/2 study testing A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide in people with Prostate Cancer, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2022to 1 Sep 2023
- Phase
- Phase 1/2
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ≥ 18 years of age;
- For patients with newly diagnosed prostate cancer : (1) adult patients with PCa confirmed by biopsy; (2) no any form of therapy against PCa within last three months; (3) planned surgical treatment;
- For patients with suspected recurrence of prostate cancer: (1)Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy; (2)Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of: Post-radical prostatectomy: Detectable or rising PSA level ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL ; or Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir;
- Life expectancy ≥3 months as determined by the investigator;
- Able and willing to provide informed consent and comply with protocol requirements.
Who cannot join
- Known allergic history to fluoride 18F-Thretide injection and/or 99mTc-MDP or its excipients;
- Patients who cannot tolerate intravenous administration (such as a history of needle sickness or blood sickness);
- Those who are not suitable for or unable to complete PET or other imaging examinations due to special reasons, including claustrophobia and radiophobia, etc.
- Practitioners requiring prolonged exposure to radioactive conditions;
- Serious diseases of the heart, kidney, lung, vascular, nervous and psychiatric systems, immune deficiency diseases and hepatitis/cirrhosis;
- Have been diagnosed with clinical recurrence of prostate cancer;
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- Patients receiving ADT treatment or chemotherapy;
- Patients who participated in clinical trials of radiopharmaceuticals within the previous 1 year;
- Participated in other interventional clinical trials within 1 month prior to screening;
- There are other conditions that the researcher considers inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
About this study
Official title: A Study to Assess the Diagnostic Performance of 18F-Thretide PET/CT in Men With Prostate Cancer
This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
Read the detailed description
Prostate-specific membrane antigen (PSMA) is overexpressed in most cases of prostate cancer and is potentially associated with metastasis and progression of prostate cancer. Compared with 68Ga, the PET radionuclide 18F exhibits several advantages. 18F-Thretide (18F-labeled PSMA ligand) has been studied for preclinical evaluation and Pilot Clinical Study. This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
- Conditions
- Prostate Cancer
- Being tested
- A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-ThretideDrug
The patients will be intravenously injected with 18F-Thretide and undergo PET/CT scan at 60~120 min after the injection.
| Study group | Role | What they receive |
|---|---|---|
| 18F-Thretide Injection | Experimental | 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide Receives: Drug: A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate at the patient level
The Difference in detection rate of 18F-Thretide PET/CT at the patient level compared with MRI, CT, or bone scanning. Within 60 days following 18F-Thretide PET/CT imaging, either MRI, CT, or bone scanning will be performed.
Measured: Within 60 days following 18F-Thretide PET/CT
detection rate at the lesion level
The difference in detection rate of 18F-Thretide PET/CT at the lesion level compared with MRI, CT, or bone scanning. Within 60 days following 18F-Thretide PET/CT, either MRI, CT, or bone scan will be performed
Measured: Within 60 days following 18F-Thretide PET/CT
sensitivity and specificity
The sensitivity and specificity of 18F-Thretide PET/CT in the diagnosis of prostate cancer compared with the composite truth standard. Within 60 days following 18F-Thretide PET/CT, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the 18F-Thretide-suspected lesion(s) will be performed
Measured: Within 60 days following 18F-Thretide PET/CT
positive predictive value
The positive predictive value (PPV) of 18F-Thretide PET/CT in the diagnosis of prostate cancer compared with the composite truth standard. Within 60 days following 18F-Thretide PET/CT, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the 18F-Thretide-suspected lesion(s) will be performed.
Measured: Within 60 days following 18F-Thretide PET/CT
Correct detection rate
The correct detection rate (CDR) of 18F-Thretide PET/CT imaging in the diagnosis of prostate cancer compared with the composite truth standard. Within 60 days following 18F-Thretide PET/CT, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the 18F-Thretide-suspected lesion(s) will be performed
Measured: Within 60 days following 18F-Thretide PET/CT
Safety evaluation
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 18F-Thretide 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 2022
- Study start20 Aug 2022
- Primary completion31 Mar 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516329
- Sponsor's protocol ID
- FirstAHFujian-PSMA
- Status last verified
- Sep 2023
- First submitted
- 4 Aug 2022
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zang J, Yang Y, Chen S, Wang C, Chen S, Hu S, Cai H, Li X, Xu N, Chen X, Zhang J, Miao W. Diagnostic Performance of [18F]AlF-Thretide PET/CT in Patients with Newly Diagnosed Prostate Cancer Using Histopathology as Reference Standard. J Nucl Med. 2024 Jul 1;65(7):1021-1026. doi: 10.2967/jnumed.123.266940.
PubMed 38724276
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Diagnostic Performance of 18F-Thretide PET/CT in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT05516329
- Acronym / sponsor ID
- FirstAHFujian-PSMA
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 Aug 2022 (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.
This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
Detailed description
Prostate-specific membrane antigen (PSMA) is overexpressed in most cases of prostate cancer and is potentially associated with metastasis and progression of prostate cancer. Compared with 68Ga, the PET radionuclide 18F exhibits several advantages. 18F-Thretide (18F-labeled PSMA ligand) has been studied for preclinical evaluation and Pilot Clinical Study. This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-Thretide Injection | Experimental | Drug: A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide7±1 mCi (259±37 MBq) IV injection of 18F-Thretide |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male ≥ 18 years of age;
- For patients with newly diagnosed prostate cancer : (1) adult patients with PCa confirmed by biopsy; (2) no any form of therapy against PCa within last three months; (3) planned surgical treatment;
- For patients with suspected recurrence of prostate cancer: (1)Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy; (2)Suspected recurrence of prostate cancer based on rising PSA after definitive therapy on the basis of: Post-radical prostatectomy: Detectable or rising PSA level ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL ; or Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir;
- Life expectancy ≥3 months as determined by the investigator;
- Able and willing to provide informed consent and comply with protocol requirements.
Key exclusion criteria (10 listed)
- Known allergic history to fluoride 18F-Thretide injection and/or 99mTc-MDP or its excipients;
- Patients who cannot tolerate intravenous administration (such as a history of needle sickness or blood sickness);
- Those who are not suitable for or unable to complete PET or other imaging examinations due to special reasons, including claustrophobia and radiophobia, etc.
- Practitioners requiring prolonged exposure to radioactive conditions;
- Serious diseases of the heart, kidney, lung, vascular, nervous and psychiatric systems, immune deficiency diseases and hepatitis/cirrhosis;
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 |
|---|---|---|
| A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-ThretideThe patients will be intravenously injected with 18F-Thretide and undergo PET/CT scan at 60~120 min after the injection. | Drug | 18F-Thretide Injection |
Primary outcome
detection rate at the patient level
Time frame: Within 60 days following 18F-Thretide PET/CT
The Difference in detection rate of 18F-Thretide PET/CT at the patient level compared with MRI, CT, or bone scanning. Within 60 days following 18F-Thretide PET/CT imaging, either MRI, CT, or bone scanning will be performed.
detection rate at the lesion level
Time frame: Within 60 days following 18F-Thretide PET/CT
The difference in detection rate of 18F-Thretide PET/CT at the lesion level compared with MRI, CT, or bone scanning. Within 60 days following 18F-Thretide PET/CT, either MRI, CT, or bone scan will be performed
sensitivity and specificity
Time frame: Within 60 days following 18F-Thretide PET/CT
The sensitivity and specificity of 18F-Thretide PET/CT in the diagnosis of prostate cancer compared with the composite truth standard. Within 60 days following 18F-Thretide PET/CT, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the 18F-Thretide-suspected lesion(s) will be performed
positive predictive value
Time frame: Within 60 days following 18F-Thretide PET/CT
The positive predictive value (PPV) of 18F-Thretide PET/CT in the diagnosis of prostate cancer compared with the composite truth standard. Within 60 days following 18F-Thretide PET/CT, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the 18F-Thretide-suspected lesion(s) will be performed.
Correct detection rate
Time frame: Within 60 days following 18F-Thretide PET/CT
The correct detection rate (CDR) of 18F-Thretide PET/CT imaging in the diagnosis of prostate cancer compared with the composite truth standard. Within 60 days following 18F-Thretide PET/CT, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the 18F-Thretide-suspected lesion(s) will be performed
Safety evaluation
Time frame: Within 7 days following 18F-Thretide 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.
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 21 Sep 2023.
- Derived from this study: PubMed 38724276Zang J, Yang Y, Chen S, Wang C, Chen S, Hu S, Cai H, Li X, Xu N, Chen X, Zhang J, Miao W. Diagnostic Performance of [18F]AlF-Thretide PET/CT in Patients with Newly Diagnosed Prostate Cancer Using Histopathology as Reference Standard. J Nucl Med. 2024 Jul 1;65(7):1021-1026. doi: 10.2967/jnumed.123.266940.
- 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 Phase 1/2 study testing A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide in people with Prostate Cancer, 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 5 inclusion and 10 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 21 Sep 2023. 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?
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?
detection rate at the patient level (time frame: Within 60 days following 18F-Thretide PET/CT). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516329, which also lists 1 linked publication.
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 21 Sep 2023.