Clinical trial · Interventional
Study of 18F-Thretide PET/CT in Patients With Prostate Cancer
A Study to Assess the Diagnostic Performance of 18F-Thretide PET/CT in Men With Prostate Cancer
NCT05516329CI-TRIAL-00069827completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-Thretide Injection
- description
- 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide
- interventionNames
- Drug: A single dose of 7±1 mCi (259±37 MBq) IV injection of 18F-Thretide
Primary outcomes (6)
- measure
- detection rate at the patient level
- timeFrame
- Within 60 days following 18F-Thretide PET/CT
- description
- 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.
- measure
- detection rate at the lesion level
- timeFrame
- Within 60 days following 18F-Thretide PET/CT
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZang 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. PMID 38724276