RecruitingPhase 1Phase 2NCT07209865

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

68Ga-P16-093 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI

Sponsor

First Affiliated Hospital of Fujian Medical University

Enrollment

50 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer (Adenocarcinoma)

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

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new PET imaging agent called 68Ga-P16-093 to the standard MRI scan (mpMRI) in men with confirmed prostate cancer, to see which scan better shows the extent of the disease before surgery. **You may be eligible if...** - You have biopsy-confirmed prostate cancer (adenocarcinoma) - You have not yet received any treatment for prostate cancer - You are scheduled for radical prostatectomy (surgical removal of the prostate) within 28 days of the PET scan - You can provide informed consent and attend all required study visits **You may NOT be eligible if...** - You have another active cancer - You have a medical condition that would interfere with obtaining reliable scan results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-P16-093

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

Locations(1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

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NCT07209865

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