# PSMA in prostate cancer

1 EU-approved indication in prostate cancer needs a PSMA result: lutetium (177Lu) vipivotide tetraxetan (3rd line+, metastatic).

## Approved indications

### PSMA-positive

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Lutetium (177Lu) vipivotide tetraxetan](https://oncolabels.com/drugs/lutetium-177lu-vipivotide-tetraxetan) (Pluvicto) | PSMA-positive | + androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition | 3rd line+, metastatic | Castration-resistant only; After AR pathway inhibition and taxane-based chemotherapy; Progressive disease |

## Label wording

- **Lutetium (177Lu) vipivotide tetraxetan** (Pluvicto), Prostate cancer, 3rd line+, metastatic: “Pluvicto in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition is indicated for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/pluvicto-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/prostate-cancer/psma