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

NCT07056790 | Recruiting Phase 1

• 1 other identifier: FAHFJ-68Ga-PSMAcyc
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate CA

Keywords

psma; prostate cancer

Outcome Measures

Primary Outcomes (2)

• Diagnostic value

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

  through study completion, an average of 1year

• Adverse events

  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 PET/CT

Secondary Outcomes (1)

• Dosimetry data

  through study completion, an average of 3 months

Study Arms (2)

Patients will undergo a 68Ga-PSMA-CYC PET/CT 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT

ACTIVE COMPARATOR

Prostate Patients received 68Ga-PSMA-CYC 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT imaging within one week. Tracer doses of 68Ga-PSMA-CYC、68Ga-PSMA-617 or 68Ga-PSMA-11 will be used to image lesions of prostate cancer by PET/CT

Drug: 68Ga-PSMA-CYC

68Ga-PSMA-CYC

EXPERIMENTAL

Experimental: dynamic PET scans PET imaging will begin at 3 minutes, 15 minutes, 30min minutes, 60 minutes and 150 minutes after injection

Drug: CYC

Interventions

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.

Patients will undergo a 68Ga-PSMA-CYC PET/CT 、68Ga-PSMA-617 or 68Ga-PSMA-11 PET/CT

CYC DRUG

The dose will be 3-4mCi given intravenously.

68Ga-PSMA-CYC

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

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 Officials

• Weibing Miao, MD

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibing Miao, MD

CONTACT

059187981618; miaoweibing@126.com

Jie Zang, MD

CONTACT

15901495106; 15901495106@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 9, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)