68Ga-P16-093 is a novel radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-P16-093 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI).

68Ga-P16-093 is a novel radiotracer targeting PSMA. Previously, we conducted multiple studies confirming the clinical application of 68Ga-P16-093 PET/CT. However, multi-parametric magnetic resonance imaging (mpMRI) still holds a dominant position in the imaging diagnosis of prostate cancer. In this study, we will further evaluate the diagnostic performance of 68Ga-P16-093 positron emission tomography (PET/CT or PET/MRI) in newly diagnosed and untreated prostate cancer patients, with a head-to-head comparison to mpMRI.

Inclusion Criteria:

• Biopsy-confirmed adenocarcinoma of the prostate.
• No anti-tumor treatment received prior to the PET imaging.
• Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
• Radical prostatectomy scheduled within 28 days after PET imaging.

Exclusion Criteria:

• Patients with other malignant tumors
• Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.