Imaging Characteristics of Different ⁶⁸Ga-PSMA Probes in Prostate Cancer

January 23, 2026 updated by: Shanghai Zhongshan Hospital

Comparative Study on Imaging Characteristics of Different ⁶⁸Ga-Labeled PSMA Probes in Patients With Prostate Cancer

This study aims to evaluate the imaging characteristics of [⁶⁸Ga]Ga-GS24-B2-250-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-250-T), [⁶⁸Ga]Ga-GS24-B2-268-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-268-T), [⁶⁸Ga]Ga-GS24-B2-237-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-237-T), and [⁶⁸Ga]Ga-PSMA-11 Injection (abbreviated as ⁶⁸Ga-PSMA-11) as PET/CT imaging agents in patients with prostate cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The subject has fully understood the trial content, process, and potential risks, and has voluntarily signed the informed consent form;
  2. Male subjects aged ≥ 18 years;
  3. Clinically or radiologically assessed as metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC);
  4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
  5. Presence of positive lesions on ⁶⁸Ga-PSMA-11 PET/CT scan;

  6. Blood routine, renal function, and liver function tests meeting the following criteria:

    1. Platelet count > 90 × 10⁹/L;
    2. Urea/urea nitrogen and serum creatinine < 1.5 × upper limit of normal (ULN);
    3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN;
  7. Expected survival time ≥ 6 months;
  8. From the date of signing the informed consent form until 3 months after administration, the subject and his partner must use effective contraceptive measures, and the subject must avoid sperm donation.

Exclusion Criteria:

  1. Having participated in another interventional clinical trial prior to signing the informed consent form and being within 5 half-lives of the investigational product of that trial; or currently participating in another interventional clinical trial; or having participated in a clinical trial involving radiopharmaceuticals prior to signing the informed consent form with an interval of less than 3 months between the last dose and the informed consent signing date.
  2. Having received any intravenous iodine-containing contrast agent within 24 hours prior to administration, or any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to administration. Oral water-soluble contrast agents (e.g., compound meglumine diatrizoate oral solution) are acceptable.
  3. Having received high-energy γ-ray-emitting agents (>300 KeV, e.g., radiopharmaceuticals labeled with radionuclides such as [¹³¹I]I, [¹⁸F]F, [⁶⁸Ga]Ga, [⁶⁴Cu]Cu, etc.) within a period equivalent to either 5 half-lives of the agent or 2 days, whichever is longer, prior to administration.
  4. Planning to adjust anti-tumor medication during the study period.
  5. Being unable to complete the required PET/CT imaging procedures.
  6. Having any medical condition or other circumstances that, in the investigator's judgment, may affect the safety or compliance of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-GS24-B2-250-T
detect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging
Diagnostic test: 68Ga-GS24-B2-250-T
detect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging
Diagnostic test: 68Ga-PSMA-11
detect prostate cancer lesions via 68Ga-PSMA-11 PET/CT imaging
Experimental: 68Ga-GS24-B2-237-T
detect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging
Diagnostic test: 68Ga-PSMA-11
detect prostate cancer lesions via 68Ga-PSMA-11 PET/CT imaging
Diagnostic test: 68Ga-GS24-B2-237-T
detect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging
Experimental: 68Ga-GS24-B2-268-T
detect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging
Diagnostic test: 68Ga-PSMA-11
detect prostate cancer lesions via 68Ga-PSMA-11 PET/CT imaging
Diagnostic test: 68Ga-GS24-B2-268-T
detect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Uptake Value for major organs (salivary glands, kidneys, bone marrow, etc.) and tumor lesions (primary and metastatic lesions)
Time Frame: 5 days
The Standardized Uptake Value (SUVmax and SUVmin) of major organs (salivary glands, kidneys, bone marrow, etc) and tumor lesions (primary and metastatic lesions) is measured by using Positron Emission Tomography/Computed Tomography (PET/CT) imaging technology for both 68Ga-PSMA-11 and other tested tracers.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 19, 2026

Primary Completion (Estimated)

June 14, 2026

Study Completion (Estimated)

July 26, 2026

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenSciP153-001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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