Study of 18F-Thretide PET/CT in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Study to Assess the Diagnostic Performance of 18F-Thretide PET/CT in Men With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516329
• Other study ID #: FirstAHFujian-PSMA
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 20, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 1, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• A single dose of 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.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 60 days following 18F-Thretide PET/CT
Primary	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	Within 60 days following 18F-Thretide PET/CT
Primary	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	Within 60 days following 18F-Thretide PET/CT
Primary	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.	Within 60 days following 18F-Thretide PET/CT
Primary	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	Within 60 days following 18F-Thretide PET/CT
Primary	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.	Within 7 days following 18F-Thretide PET/CT