Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in PCa Diagnosis, Recurrence, and Metastasis

Early Phase 1

Recruiting

• Conditions: Prostate Cancer; PET/CT
• Interventions: Drug: [68Ga]Ga-PSMA-D5; Drug: [68Ga]Ga-PSMA-11

• Registration Number: NCT05955677
• Lead Sponsor: Anhui Provincial Hospital

Brief Summary

To prospectively evaluate the radiodrug biodistribution of a novel PET imaging agent \[68Ga\]Ga-PSMA-D5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[68Ga\]Ga-PSMA-11.

Detailed Description

\[68Ga\]Ga-PSMA-D5 PET/CT was used for initial assessment of prostate cancer or detection of recurrence. The maximum standardized uptake value (SUVmax) was used to evaluate tumor uptake. The sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[68Ga\]Ga-PSMA-11 PET/CT.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-10
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-19
• Last Update Submitted: 2023-07-19
• Study First Posted: 2023-07-21
• Last Update Posted: 2023-07-21
• Primary Completion: 2024-07-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• Aged from 18 to 90 years old;
• Complete MRI images and clinical data (such as PSA level, Gleason grade, etc.);
• Prostate cancer detected by PSA or imaging examination, or clinically suspected recurrence after standardized treatment;
• simultaneous [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 examinations within two weeks;
• Willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment;
• Sign informed consent.

Exclusion Criteria

• Patients who cannot cooperate with the examination;
• Concurrent malignant tumors;
• Previous alcohol allergy;
• Patients with liver and kidney dysfunction;
• Other circumstances deemed by the investigator to be inappropriate for trial participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan	[68Ga]Ga-PSMA-D5	Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11.
[68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan	[68Ga]Ga-PSMA-11	Subjects PET/CT imaging: On any two days for two consecutive weeks, each subject underwent a PET/ CT scan after intravenous injection of \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11.

Primary Outcome Measures

Name	Time	Method
Standard uptake value(SUV)	30 days	Standard uptake value(SUV) of \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 for each target lesion of subjects.

Secondary Outcome Measures

Name	Time	Method
Number of lesions	30 days	The number of lesions detected by \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 PET/CT.
Diagnostic efficacy	30 days	The sensitivity, specificity and accuracy of \[68Ga\]Ga-PSMA-D5 and \[68Ga\]Ga-PSMA-11 PET/CT were calculated.

Trial Locations

Locations (1)

The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）; 🇨🇳 Hefei, Anhui, China