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NCT Number: NCT05516329

Study of 18F-Thretide PET/CT in Patients 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Fuzhou, Fujian, 350005, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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