Prostate CancerNCT07365397

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

A study testing 68Ga-GS24-B2-268-T, 68Ga-GS24-B2-250-T and 68Ga-GS24-B2-237-T in people with Prostate Cancer, run by Shanghai Zhongshan Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostate Cancer
What is being tested?: 68Ga-GS24-B2-268-T, 68Ga-GS24-B2-250-T and 68Ga-GS24-B2-237-T
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: No sites listed yet
Study dates: 19 Jan 2026to 26 Jul 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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Platelet count > 90 × 10⁹/L;
Urea/urea nitrogen and serum creatinine < 1.5 × upper limit of normal (ULN);
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN;
Expected survival time ≥ 6 months;
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.

Who cannot join

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.
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.
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.
Planning to adjust anti-tumor medication during the study period.
Being unable to complete the required PET/CT imaging procedures.
Having any medical condition or other circumstances that, in the investigator's judgment, may affect the safety or compliance of the subject.

About this study

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

Conditions: Prostate Cancer
Being tested: 68Ga-GS24-B2-268-T, 68Ga-GS24-B2-250-T, 68Ga-GS24-B2-237-T, 68Ga-PSMA-11
Medical subject headings: Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

68Ga-GS24-B2-268-TDiagnostic test
detect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging
68Ga-GS24-B2-250-TDiagnostic test
detect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging
68Ga-GS24-B2-237-TDiagnostic test
detect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging
68Ga-PSMA-11Diagnostic test
detect prostate cancer lesions via 68Ga-PSMA-11 PET/CT imaging

Study groups in NCT07365397
Study group	Role	What they receive
68Ga-GS24-B2-250-T	Experimental	detect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging Receives: Diagnostic Test: 68Ga-GS24-B2-250-T; Diagnostic Test: 68Ga-PSMA-11
68Ga-GS24-B2-237-T	Experimental	detect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging Receives: Diagnostic Test: 68Ga-GS24-B2-237-T; Diagnostic Test: 68Ga-PSMA-11
68Ga-GS24-B2-268-T	Experimental	detect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging Receives: Diagnostic Test: 68Ga-GS24-B2-268-T; Diagnostic Test: 68Ga-PSMA-11

What is being measured

The primary outcome is the main question the study is designed to answer.

Standardized Uptake Value for major organs (salivary glands, kidneys, bone marrow, etc.) and tumor lesions (primary and metastatic lesions)
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.
Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 202626 Jul 2026

First posted26 Jan 2026
Study start19 Jan 2026 (estimated)
Primary completion14 Jun 2026 (estimated)
Study completion26 Jul 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate CancerStudies of the same condition, open and under way.
More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 9 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07365397
Sponsor's protocol ID: GenSciP153-001
Status last verified: Jan 2026
First submitted: 14 Jan 2026
Last updated: 26 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparative Study on Imaging Characteristics of Different ⁶⁸Ga-Labeled PSMA Probes in Patients With Prostate Cancer
ClinicalTrials.gov ID: NCT07365397
Acronym / sponsor ID: GenSciP153-001
Conditions: Prostate Cancer
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 9 participants (estimated)
Lead sponsor: Shanghai Zhongshan HospitalUniversity, hospital or other
Study start: 19 Jan 2026 (estimated)
Primary completion: 14 Jun 2026 (estimated)
Study completion: 26 Jul 2026 (estimated)
First posted: 26 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
68Ga-GS24-B2-250-T	Experimental	Diagnostic Test: 68Ga-GS24-B2-250-T, Diagnostic Test: 68Ga-PSMA-11detect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging
68Ga-GS24-B2-237-T	Experimental	Diagnostic Test: 68Ga-GS24-B2-237-T, Diagnostic Test: 68Ga-PSMA-11detect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging
68Ga-GS24-B2-268-T	Experimental	Diagnostic Test: 68Ga-GS24-B2-268-T, Diagnostic Test: 68Ga-PSMA-11detect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (6 listed)

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.
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.
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.
Planning to adjust anti-tumor medication during the study period.
Being unable to complete the required PET/CT imaging procedures.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
68Ga-GS24-B2-268-Tdetect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging	Diagnostic test	68Ga-GS24-B2-268-T
68Ga-GS24-B2-250-Tdetect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging	Diagnostic test	68Ga-GS24-B2-250-T
68Ga-GS24-B2-237-Tdetect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging	Diagnostic test	68Ga-GS24-B2-237-T
68Ga-PSMA-11detect prostate cancer lesions via 68Ga-PSMA-11 PET/CT imaging	Diagnostic test	68Ga-GS24-B2-237-T, 68Ga-GS24-B2-250-T, 68Ga-GS24-B2-268-T

Primary outcome

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.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Individual participant dataSharing planned: No

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Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing 68Ga-GS24-B2-268-T, 68Ga-GS24-B2-250-T and 68Ga-GS24-B2-237-T in people with Prostate Cancer, run by Shanghai Zhongshan Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standardized Uptake Value for major organs (salivary glands, kidneys, bone marrow, etc.) and tumor lesions (primary and metastatic lesions) (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07365397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.