Prostate Cancer
Conditions
Brief summary
This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of prostate cancer.
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. Patients with suspected metastatic prostate cancer will undergo imaging with ⁶⁸Ga NYM032 Injection, a PSMA targeted radiotracer.
Interventions
DIAGNOSTIC_TEST68-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. Participants with histopathologically confirmed prostate adenocarcinoma, who present with elevated PSA and suspected recurrence following radical prostatectomy and/or radiotherapy and/or other radical prostate cancer treatments (e.g., proton therapy, cryoablation, high-intensity focused ultrasound, etc.). (PSA must be measured within 30 days prior to screening.). (Meeting any one of the following criteria): 1. Post-radical prostatectomy (RP): PSA ≥0.2 ng/mL on two consecutive measurements obtained ≥6 weeks after surgery; 2. Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng/mL above the PSA nadir; 3. Participants with recurrence after other treatments: PSA rise ≥2 ng/mL above the PSA nadir. 3. ECOG performance status 0-2; expected survival ≥ 6 months. 4. 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 |
|---|---|---|
| PPV | up to12 months | Positive predictive value (PPV)were calculated on a per-patient basis on 68Ga-NYM032 PET/CT for detection of tumor location confirmed by the composite truth standard. |
Countries
China
Outcome results
None listed