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NCT Number: NCT07056790

Research on the Application of 68Ga-PSMA-CYC PET Imaging in the Diagnosis, Staging, and Restaging of Prostate Cancer

68Ga-PSMA-CYC is a novel radiotracer targeting PSMA. In this study, we investigated the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.

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Key information

Conditions

Prostate CA 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

About this study

Prostate cancer (PCa) is one of the most common malignant tumors among men worldwide. Prostate-specific membrane antigen (PSMA) is a transmembrane glycoprotein that is highly expressed in PCa and its metastatic lesions, making it an ideal target for the precise diagnosis and treatment of PCa. Various low-molecular-weight radiopharmaceuticals targeting PSMA have been developed, such as PSMA-11 and PSMA-617, which can be labeled with 68Ga or 177Lu. 68Ga-PSMA-CYC is a novel radiotracer that has demonstrated favorable in vivo and in vitro stability in preliminary studies, with specific accumulation in PCa, high binding affinity, and good safety profile, making it a promising candidate for further investigation. This prospective study aims to investigate the safety, biodistribution, radiation dosimetry of 68Ga-PSMA-CYC PET/CT in patients with prostate cancer, and performed a head-to-head comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 to evaluate its diagnostic performance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed treated or untreated prostate cancer patients;
  • signed written consent.

Exclusion criteria

  • known allergy against PSMA;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Treatment and study plan

68Ga-PSMA-CYC

Drug

Each prostate cancer patient underwent a 68Ga-PSMA-CYC (3-4 mCi) PET/CT scan, as well as a 68Ga-PSMA-617 (3-4 mCi) or 68Ga-PSMA-11 (3-4 mCi) PET/CT scan, with the time interval between the two scans not exceeding one week.

CYC

Drug

The dose will be 3-4mCi given intravenously.

Primary outcomes

  1. Diagnostic value

    Time frame: through study completion, an average of 1year

    Sensitivity and Specificity of 68Ga-PSMA-CYC for prostate cancer in comparison with 68Ga-PSMA-617 and 68Ga-PSMA-11 PET/CT.

  2. Adverse events

    Time frame: Within 7 days following 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.

Secondary outcomes

  1. Dosimetry data

    Time frame: through study completion, an average of 3 months

    Calculate the absorbed dose of 68Ga-PSMAcyc in normal organs.

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Zang, MD

CONTACT

[email protected]

15901495106

Weibing Miao, MD

CONTACT

[email protected]

059187981618

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

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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