Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07052214 | PSMA PET Combined With MRI for the Detection of PCa | PHASE3 | RECRUITING | 204 | — | — | Aug 18, 2025 | Nov 1, 2026 | Sep 10, 2025 | 1 | Australia |
To evaluate the diagnostic performance of combined 68Ga-PSMA-11 PET and MRI targeted biopsy for the detection of PCa, using histopathological confirmation as the SOT.
To assess the sensitivity and specificity of 68Ga-PSMA-11 PET as adjunct to MRI or the detection of PCa, confirmed by predefined standard of truth (SOT).
| Arm | Type | Description |
|---|---|---|
| Illuccix: 68Ga-PSMA-11/Gallium Ga 68 Gozetotide | OTHER | This is a single arm study. All participants will first undergo mpMRI and PSMA PET scans (one single IV bolus of Gallium Ga 68 Gozetotide administered) |
| Name | Type | Description |
|---|---|---|
| 68Ga-PSMA-11 | DRUG | The radioconjugate 68Ga-PSMA-11 is composed of a human PSMA-targeting ligand peptide conjugated via the acyclic radiometal chelator, N, N'-bis \[2-hydroxy-5-(carboxyethyl)benzyl\] ethylenediamine-N, N'-diacetic acid (HBED-CC) to the radioisotope Gallium68 ( 68Ga); which binds to PSMA on the surface of cells expressing PSMA, including malignant prostate cancer cells, which usually overexpress PSMA. 68Ga is a β+ (beta) ray emitting radionuclide that allows precise imaging via PET. |
Inclusion Criteria: 1. Male, at least 18 years old. 2. Have a clinical suspicion of PCa, and will undergo template biopsy, based on either: an initial MRI examination (PI-RADS 3-4) within 3 months (92 days) before enrollment, or no MRI evidence (PI-RADs 1-2) within 3 months (92 days) before enrollm...