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Gallium-68 PSMA-11 was the first PSMA PET tracer approved in the US (2020), and is made on site from a generator or cyclotron.
Gallium-68 gozetotide (PSMA-11) is a 68Ga-labelled urea-based ligand that binds prostate-specific membrane antigen, lighting up prostate cancer on PET wherever it has spread. It is made on site from a germanium-68 generator or cyclotron and used for initial staging of higher-risk disease, for biochemical recurrence, and to confirm PSMA expression before 177Lu-PSMA-617 therapy. The UCLA/UCSF academic NDA (2020) established PSMA PET in the US, followed by Telix's Illuccix kit (2021) and Gozellix (2025, longer shelf-life) and Novartis' Locametz (2022, companion for Pluvicto). It competes with 18F agents (Pylarify, Posluma) that offer central distribution and a longer half-life. Whether findings on PSMA PET should change treatment in the absence of outcome trials remains debated. In plain terms, it was the first PSMA PET tracer approved in the US.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
68Ga-labelled urea-based PSMA ligand. Connects to PSMA.
1.Gallium-68 gozetotide (PSMA-11) slips into a pocket on PSMA.
Diagnostic radiopharmaceutical billed with the PET/CT scan under Part B. Since 2025, Medicare's hospital outpatient system pays separately for diagnostic radiopharmaceuticals whose per-day cost exceeds a threshold, which covers PSMA agents. Medicare Administrative Contractors decide PET coverage for prostate cancer; all now cover PSMA PET for initial staging of unfavourable risk disease and biochemical recurrence.
PSMA PET is covered by most commercial plans for staging and recurrence with prior authorisation for the imaging procedure; radiology benefit managers apply appropriateness criteria.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Diagnostic non-laboratory tests (imaging). Not medical or financial advice; verify with your plan.
Sources: NICE search: gallium-68 PSMA-11 PET. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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| Region | Year | Indication |
|---|---|---|
| US | 2020 | PSMA PET (UCLA/UCSF NDA); kits 2021-2022 |
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Query for this drug: (TITLE:"Gallium-68 gozetotide" OR ABSTRACT:"Gallium-68 gozetotide" OR TITLE:"PSMA-11" OR ABSTRACT:"PSMA-11" OR TITLE:"Illuccix" OR ABSTRACT:"Illuccix" OR TITLE:"Gozellix" OR ABSTRACT:"Gozellix" OR TITLE:"Locametz" OR ABSTRACT:"Locametz") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gallium-68 gozetotide (PSMA-11), not a curated reading list.
Shares Diagnostic accuracy of 68Ga-PSMA-11 PET for pelvic nodal metastasis detection prior to radical prostatectomy and pelvic lymph node dissection: a multicenter prospective phase 3 imaging trial, PSMA-PreRP, UCSF Helen Diller Family Comprehensive Cancer Center, PSMA.
Shares UCLA Jonsson Comprehensive Cancer Center, PSMA, PSMA PET, Prostate cancer.
Shares UCLA Jonsson Comprehensive Cancer Center, PSMA, PSMA PET, Prostate cancer.
Shares PSMA expression by PET (PSMA-positive), PSMA, PSMA PET, Prostate cancer.
Shares UCSF Helen Diller Family Comprehensive Cancer Center, PSMA, PSMA PET, Prostate cancer.
Shares PSMA expression by PET (PSMA-positive), PSMA, PSMA PET, Prostate cancer.
Shares Illuccix (kit for Ga-68 gozetotide), PSMA expression by PET (PSMA-positive), PSMA, PSMA PET.
Shares PSMA expression by PET (PSMA-positive), PSMA, PSMA PET, Prostate cancer.