68Ga-P16-093 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18-80
SponsorFirst Affiliated Hospital of Fujian Medical University

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 68Ga-P16-093

Treatment groups

50 Participants
are divided into 1 treatment group