68Ga-PSMA-11 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI

Fujian Medical University (FJMU)

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Prostate Cancer (Adenocarcinoma)

Treatments

Drug: 68Ga-PSMA-11

Study type

Interventional

Funder types

Other

Identifiers

NCT07209878

FirstAHFujian-68Ga-PSMA-11

Details and patient eligibility

About

68Ga-PSMA-11 is a widely used radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-PSMA-11 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-PSMA-11 is a radiotracer targeting PSMA. Previously, multiple clinical trials have validated the clinical applications of 68Ga-PSMA-11 PET. Meanwhile, 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-PSMA-11 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

100 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.