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

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Criteria

Inclusion Criteria:

• Male ≥ 18 years of age;

• Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy;

• 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.