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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; PET/CT
• Intervention / Treatment: Drug: [68Ga]Ga-PSMA-D5; Drug: [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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Qiang Xie, MD; Phone Number: +8613721108043; Email: xieqiang1980@ustc.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • The First Affiliated Hospital of China University of Science and Technology（Anhui Provincial Hospital）
      • Contact: Qiang Xie, MD; Phone Number: +8613721108043; Email: xieqiang1980@ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Investigators: Study Chair: Qiang Xie, The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Disease Attributes; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Recurrence; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: First D5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No