- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05516329
Study of 18F-Thretide PET/CT in Patients With Prostate Cancer
September 16, 2023 updated by: Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jie Zang, PhD, MD
- Phone Number: 86-0591-87981619
- Email: 15901495106@163.com
Study Contact Backup
- Name: weibing miao, MD
- Phone Number: 86-0591-87981618
- Email: miaoweibing@126.com
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China, 350005
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
-
Contact:
- Jie Zang, PhD, MD
- Phone Number: 86-0591-87981619
- Email: 15901495106@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 18F-Thretide Injection
7±1 mCi (259±37 MBq) IV injection of 18F-Thretide
|
The patients will be intravenously injected with 18F-Thretide and undergo PET/CT scan at 60~120 min after the injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Within 60 days following 18F-Thretide PET/CT
|
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
|
Within 60 days following 18F-Thretide PET/CT
|
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
|
Within 60 days following 18F-Thretide PET/CT
|
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.
|
Within 60 days following 18F-Thretide PET/CT
|
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
|
Within 60 days following 18F-Thretide PET/CT
|
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.
|
Within 7 days following 18F-Thretide PET/CT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2022
Primary Completion (Actual)
March 31, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
August 4, 2022
First Submitted That Met QC Criteria
August 23, 2022
First Posted (Actual)
August 25, 2022
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 16, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FirstAHFujian-PSMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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