Lutetium (177Lu) vipivotide tetraxetan (Pluvicto): radioactive drug that delivers radiation directly to prostate cancer cells expressing PSMA. Used in metastatic castration-resistant prostate cancer.
177Lu-PSMA-617, Pluvicto, lutetium Lu 177 vipivotide tetraxetan, Lu-PSMA-617
Regulatory status
FDA (US): Approved (2022, Pluvicto) for PSMA-positive metastatic castration-resistant prostate cancer after an androgen receptor pathway inhibitor and a taxane; expanded (March 2025) to patients who have not yet received a taxane when it is appropriate to delay it.
EMA (EU): Approved (December 2022, Pluvicto) for progressive, PSMA-positive metastatic castration-resistant prostate cancer after an androgen pathway inhibitor and taxane chemotherapy. No approved expansion to taxane-naive patients.
Dose
7.4 GBq (200 mCi) intravenously every 6 weeks, up to 6 doses or until progression or unacceptable toxicity (FDA label 2025; VISION and PSMAfore trials).
Safety
Exposes to radiation; may cause myelosuppression (anemia, low platelets and white blood cells), kidney toxicity, dry mouth, fatigue, and nausea. In VISION, serious adverse effects (grade ≥3) were more frequent than with standard treatment alone (52.7% versus 38.0%). May affect fertility. Administered only in nuclear medicine departments under specialized supervision.
Interactions
Given together with androgen deprivation therapy. Caution with other treatments that damage the bone marrow or kidney.
Differences between women and men
Indication exclusively for men (prostate cancer). The label warns of possible male infertility and requires effective contraception during and after treatment because of radiation exposure.
Effect by goal · level of evidence
Survival in metastatic prostate cancer after chemotherapy
improvesHighRCT (AA)in people
+4 months of life
VISION trial (831 men already treated with hormone therapy and a taxane): adding 177Lu-PSMA-617 to standard treatment extended overall survival from 11.3 to 15.3 months (HR 0.62) and radiographic progression-free survival from 3.4 to 8.7 months (HR 0.40).
PSMAfore trial (468 taxane-naive men): versus switching hormone therapy, radiographic progression-free survival was 9.3 versus 5.6 months (HR 0.41). Serious adverse effects were less frequent (36% versus 48%).
The molecule has one part that binds to PSMA, a protein highly abundant on the surface of prostate cancer cells, and another that carries lutetium-177, a radioactive isotope. Once bound, the beta radiation damages the DNA of the tumor cell and its neighbors. Before treatment, a PET scan is used to confirm that the tumor expresses PSMA.
What the evidence says
In people
Survival in metastatic prostate cancer after chemotherapy. VISION trial (831 men already treated with hormone therapy and a taxane): adding 177Lu-PSMA-617 to standard treatment extended overall survival from 11.3 to 15.3 months (HR 0.62) and radiographic progression-free survival from 3.4 to 8.7 months (HR 0.40). PubMed 34161051
Tumor control before chemotherapy. PSMAfore trial (468 men with no prior taxane): compared with switching hormone therapy, radiographic progression-free survival was 9.3 vs 5.6 months (HR 0.41). Serious adverse effects were less frequent (36% vs 48%). PubMed 39293462