68Ga-PSMA-11 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI
Recruiting
Phase 2
Phase 3
Interventional Study
Prostate Cancer (Adenocarcinoma)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Male
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 100 (estimated)
- Sponsor
- First Affiliated Hospital of Fujian Medical University · Other
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About This Trial
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).
Trial Locations
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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 withi…
Contacts