Prostate Cancer (Diagnosis)
Conditions
Brief summary
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
DRUG68-Ga-NYM032
IV injection
Sponsors
Norroy Bioscience Co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is male and aged \>18 years old. 2. Biopsy proven prostate adenocarcinoma. 3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND). 4. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity and specificity | up to 30 days | Assessing the sensitivity and specificity of 68Ga-NYM032 Injection positron emission tomography (PET) on a patient level compared to the histopathology of pelvic lymphatic tissue removed during RP and PLND. |
Countries
China
Outcome results
None listed