Not yet recruiting NCT07365397
Imaging Characteristics of Different ⁶⁸Ga-PSMA Probes in Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-GS24-B2-268-T, 68Ga-GS24-B2-250-T, 68Ga-GS24-B2-237-T, 68Ga-PSMA-11.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Study on Imaging Characteristics of Different ⁶⁸Ga-Labeled PSMA Probes in Patients With Prostate Cancer
Overview
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.
Interventions
- Diagnostic test 68Ga-GS24-B2-268-T
detect prostate cancer lesions via 68Ga-GS24-B2-268-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-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
Primary outcome measures
- Standardized Uptake Value for major organs (salivary glands, kidneys, bone marrow, etc.) and tumor lesions (primary and metastatic lesions) [Time frame: 5 days]
Eligibility criteria
Inclusion criteria
- 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:
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07365397 · GenSciP153-001