Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed 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: 68-Ga-NYM032.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Diagnosis). Basic parameters: from 18 Days · Female.
- 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 →
Unsure about the terms? Read our patient guide →
Official title
Open-label, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of 68Ga-NYM032 Injection PET/CT in Men With Newly Diagnosed Prostate Cancer.
Overview
The investigators are imaging patients with newly diagnosed prostate cancer using a new Positron Emission Tomography (PET) imaging agent (68Ga-NYM032) in order to evaluate the safety and diagnostic performance.
Detailed description
Imaging and staging of prostate cancer is critical for surgical and treatment planning. Prostate-specific membrane antigen (PSMA) is a transmembrane surface protein highly overexpressed in over 90% of prostate cancer lesions.⁶⁸Ga-NYM032 Injection, a PSMA-targeted radiotracer, is indicated for PET/CT imaging in patients with prostate cancer. Patients will receive 68Ga-NYM032 imaging to identify pelvic lymph node involvement.
Interventions
- Drug 68-Ga-NYM032
IV injection
Primary outcome measures
- sensitivity and specificity [Time frame: up to 30 days]
Eligibility criteria
Inclusion criteria
- Patient is male and aged >18 years old.
- Biopsy proven prostate adenocarcinoma.
- Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
- ECOG performance status 0-2; expected survival ≥ 6 months.
6\. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion criteria
- 1\. Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.
2\. Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
3\. Known hypersensitivity to the active ingredient or excipients of the study drug.
4\. Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
5\. Any medical condition or circumstance that, in the investigator's judgment, may compromise study safety or patient compliance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07615101 · G03202