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

Study Overview
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Brief Summary
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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
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[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.

Official Title
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Head-to-head Comparison of [68Ga]Ga-PSMA-D5 With [68Ga]Ga-PSMA-11 PET/CT in Prostate Cancer Diagnosis, Recurrence, and Metastasis: a Prospective Study

Conditions
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PET/CT, Prostate Cancer

Intervention / Treatment
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* Drug: [68Ga]Ga-PSMA-D5
* Drug: [68Ga]Ga-PSMA-11


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/ CT scan<br>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. | Drug: [68Ga]Ga-PSMA-D5<br>* Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-D5, and undergo PET/CT imaging within the specificed time.<br>* Other names: [68Ga]Ga-PSMA-D5 injection;Drug: [68Ga]Ga-PSMA-11<br>* Each subject receive a single intravenous injection of [68Ga]Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.<br>* Other names: [68Ga]Ga-PSMA-11 injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard uptake value(SUV) | Standard uptake value(SUV) of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 for each target lesion of subjects. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic efficacy | The sensitivity, specificity and accuracy of [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/CT were calculated. | 30 days | 
| Number of lesions | The number of lesions detected by [68Ga]Ga-PSMA-D5 and [68Ga]Ga-PSMA-11 PET/CT. | 30 days |