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Label indication ILLUCCIX, after radiolabeling with Ga 68, is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level For selection of patients who are indicated for PSMA-directed therapy…
Also known as Illuccix, Gallium Ga 68 Gozetotide
68Ga-PSMA-11 · 1 trial · 9 indications
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 csPCa, and indicated for template biopsy after having received an MRI demonstrating PI-RADs 1 to 4 within 6 months of enrollment and/or have non-imaging risk factors (including but not exclusive to): a) Persiste...
68Ga-PSMA-11 is an investigational small-molecule imaging agent being developed by Telix Pharmaceuticals for prostate cancer. It is used in positron emission tomography (PET) imaging to visualize PSMA-expressing tissue, and it is being studied in combination with MRI for the detection of prostate cancer.
68Ga-PSMA-11 is used for PET imaging in prostate cancer, including detection of disease in men with elevated PSA undergoing prostate biopsy evaluation. Telix Pharmaceuticals is studying it combined with MRI for prostate cancer detection in a Phase 3 trial enrolling men aged 18 and older in the United States and Australia.
68Ga-PSMA-11 targets PSMA, or prostate-specific membrane antigen, a protein target. The agent is a small molecule labeled with gallium-68 that binds PSMA, allowing PET imaging to visualize PSMA-expressing tissue in prostate cancer.
68Ga-PSMA-11 is being developed by Telix Pharmaceuticals Limited, which trades under the ticker TLX. The company is advancing the imaging agent in oncology, specifically for prostate cancer imaging applications.
68Ga-PSMA-11 is in Phase 3 clinical development and is investigational. It has not been established as approved for commercial use based on the development information available, and its Phase 3 program is ongoing.
68Ga-PSMA-11 is being studied in the Phase 3 trial NCT07052214, titled PSMA PET Combined With MRI for the Detection of PCa. The trial is active but not recruiting, has an enrollment of 338 participants, is uncontrolled, and is conducted in the United States and Australia in male participants aged 18 years and older.