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Recruiting Phase 1, Phase 2 NCT07209865

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

Trial Parameters

Condition Prostate Cancer (Adenocarcinoma)
Sponsor First Affiliated Hospital of Fujian Medical University
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 50
Sex MALE
Min Age 18 Years
Max Age 80 Years
Start Date 2024-10-01
Completion 2025-12-31
Interventions
68Ga-P16-093

Brief Summary

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

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.

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