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

NCT05516329 | Completed Phase 1

• 1 other identifier: FirstAHFujian-PSMA
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

18F-Thretide Injection

EXPERIMENTAL

7±1 mCi (259±37 MBq) IV injection of 18F-Thretide

Drug: A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide

Interventions

A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide DRUG

The patients will be intravenously injected with 18F-Thretide and undergo PET/CT scan at 60\~120 min after the injection.

18F-Thretide Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine Department

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 25, 2022
• Study Start: August 20, 2022
• Primary Completion: March 31, 2023
• Study Completion: September 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)