Ga-68 PSMA PET/CT vs mpMRI in Cognitive Prostate Biopsy (NCT07533344)
Summary
The NIH ClinicalTrials.gov registry has registered observational study NCT07533344, an NCI-affiliated trial conducted by Stanford University comparing Ga-68 PSMA PET/CT imaging with multiparametric MRI (mpMRI) in cognitive prostate biopsy for prostate cancer diagnosis. The single-arm study will enroll approximately 100 participants and is estimated to begin enrollment on April 16, 2026.
What changed
The NIH has registered observational study NCT07533344 on ClinicalTrials.gov. The study will compare Ga-68 PSMA PET/CT and mpMRI imaging modalities for guiding cognitive prostate biopsy in prostate cancer diagnosis. This is an observational study, not an interventional trial, and does not impose regulatory compliance obligations on any party.
Healthcare providers and clinical investigators interested in prostate cancer diagnostics should monitor this trial for potential impact on diagnostic imaging practices. The study addresses a clinical question about whether PSMA PET/CT, now FDA-approved for staging, can improve targeted biopsy outcomes compared to mpMRI alone. Results may inform future diagnostic protocols but do not create any immediate compliance requirements.
What to do next
- Monitor ClinicalTrials.gov for study updates
- Review inclusion/exclusion criteria if considering participation
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Ga-68 PSMA PET/CT vs mpMRI in Cognitive Prostate Biopsy
Observational NCT07533344 Kind: OBSERVATIONAL Apr 16, 2026
Abstract
Prostate cancer is the most common malignancy among elderly men. With the routine use of prostate-specific antigen (PSA) testing since the 1980s, the incidence of prostate cancer has significantly increased. The diagnosis of prostate cancer is established through prostate biopsy, and several biopsy techniques have been developed in recent years.
Prostate biopsy can be broadly classified into systematic and targeted biopsy techniques. Systematic biopsy is performed under transrectal or transperineal ultrasound guidance without the use of prior imaging. Targeted biopsy techniques include cognitive biopsy, multiparametric magnetic resonance imaging (mpMRI) fusion biopsy, in-bore MRI biopsy, and robotic biopsy.
Cognitive biopsy is defined as the targeting of lesions identified on pre-biopsy imaging, usually multiparametric prostate MRI. MRI-fusion biopsy integrates mpMRI images with real-time ultrasound images, while in-bore biopsy is performed directly under MRI guidance. Although MRI-fusion biopsy is considered the gold standard technique, cognitive biopsy is more commonly used in developing countries due to lower cost and reasonable diagnostic accuracy.
Recently, Ga-68 prostate-specific membrane antigen (PSMA) PET/CT has become the gold standard imaging modality for staging prostate cancer after receiving FDA approval. PSMA is a type II transmembrane protein highly expressed on prostate cancer cells. PSMA PET/CT has high sensitivity and specificity for the detection, sta...
Conditions: Prostate Cancer
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