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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Prostate Cancer (Adenocarcinoma)

Treatments: Drug: 68Ga-P16-093

Study type: Interventional

Funder types: Other

Identifiers

NCT07209865

FirstAHFujian-68Ga-P16-093

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

68Ga-P16-093 PET/CT

Experimental group

Description:

Intravenous injection of 68Ga-P16-093 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT or PET/MRI acquisition according to standard methods.

Treatment:

Drug: 68Ga-P16-093