PSMAddition trial is a Phase 3 study testing 177Lu-PSMA-617, known as Pluvicto, for metastatic hormone-sensitive prostate cancer (mHSPC).

In June it was announced that the trial met its primary endpoint, showing Pluvicto, when combined with standard treatments like androgen deprivation therapy and androgen receptor pathway inhibitors, significantly extended radiographic progression-free survival (rPFS) compared to standard care alone.

This means it delayed the time until the cancer worsened on imaging, which is a key measure of treatment success. There’s also a positive trend in overall survival, but the data aren’t fully mature yet, so we don’t have final numbers.

No new safety concerns were reported, with side effects like fatigue and dry mouth consistent with what’s known from earlier studies.  These results will be submitted for regulatory review in the second half of 2025, and full details are expected to be shared at a medical meeting this fall (maybe ESMO 2025). This is promising news for patients, as it suggests Pluvicto could play a role earlier in the disease, potentially improving outcomes.

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