Clinical trial · Interventional
68Ga-PSMA-11 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI
68Ga-PSMA-11 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI
NCT07209878CI-TRIAL-00096354recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Adenocarcinoma) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-PSMA-11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-PSMA-11 PET/CT
- description
- Intravenous injection of 68Ga-PSMA-11 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT or PET/MRI acquisition according to standard methods
- interventionNames
- Drug: 68Ga-PSMA-11
Primary outcomes (2)
- measure
- Sensitivity of 68Ga-PSMA-11 Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants
- timeFrame
- Within 28 days of imaging, radical prostatectomy will occur.
- description
- Using histopathology from radical prostatectomy as the reference standard, validate the true positive detection rate of PET for prostate lesions. Two experienced nuclear medicine physicians, blinded to all other imaging and clinical history of the patients, independently assessed the PET images. Any disagreements were resolved by consensus.
- measure
- Specificity of 68Ga-PSMA-11 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.