LOCAMETZ (gallium (68Ga) gozetotide) - Prostate cancer

First assessment.

Key points

Favourable opinion on reimbursement in the MA indication: "for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with positron emission tomography (PET) in adults with prostate cancer (PC) in the following clinical settings:

• primary staging of patients with high-risk PC prior to primary curative therapy,
• suspected PC recurrence in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy,
• identification of patients with PSMA-positive, progressive, metastatic, castration-resistant prostate cancer (mCRPC), for whom PSMA-targeted therapy is indicated."

Role in the diagnostic strategy?

LOCAMETZ (gallium (68Ga) gozetotide) plays a role in the diagnostic strategy:

• for the primary staging of patients presenting with high-risk PC before a primary curative treatment. It is an additional alternative as an optional examination, according to current recommendations.
• in case of suspected PC recurrence in patients with increasing levels of serum PSA after a primary curative treatment. It is a first-line examination, in the same way as RADELUMIN.
• for the identification of patients with PSMA-positive, progressive, mCRPC, for whom PSMA-targeted therapy is indicated. It is a first-line examination, for the identification of PSMA-positive patients.