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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 a small molecule diagnostic imaging agent used in prostate cancer (PCA) to detect the disease via PSMA PET imaging. It is being studied in a Phase 3 clinical trial for the detection of prostate cancer in patients with elevated PSA levels, potentially guiding prostate biopsy decisions.
68Ga-PSMA-11 targets prostate-specific membrane antigen (PSMA), a protein highly expressed on prostate cancer cells. By binding to PSMA, the radiolabeled molecule enables positron emission tomography (PET) imaging to visualize prostate cancer lesions, aiding in diagnosis and detection.
68Ga-PSMA-11 is being developed by Telix Pharmaceuticals Limited, listed on the Australian Securities Exchange under the ticker TLX. The company is conducting a Phase 3 clinical trial to evaluate the agent for prostate cancer detection.
68Ga-PSMA-11 is in Phase 3 clinical development. It is an investigational diagnostic agent, not yet approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants to assess its performance in detecting prostate cancer.
68Ga-PSMA-11 is being evaluated in one active Phase 3 clinical trial, NCT07052214, titled 'PSMA PET Combined With MRI for the Detection of PCa'. This non-randomized, uncontrolled study aims to enroll 338 male participants aged 18 years and older across the United States and Australia.
68Ga-PSMA-11 is a specific radiotracer used in PSMA PET imaging. PSMA PET refers to the imaging technique itself, while 68Ga-PSMA-11 is the diagnostic agent that binds to PSMA to enable the scan. In clinical trials, it is being studied in combination with MRI for prostate cancer detection.