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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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