Prescribing information

This page/content is for Great Britain healthcare professionals only.

Pluvicto® is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.2



When patients progress to mCRPC their prognosis decreases significantly3,4

Graphic illustrating the prognosis of patients with mCRPC

>80% of patients with mCRPC are PSMA-positive, making PSMA an actionable therapeutic and diagnostic target1,10–11

PSMA scanning enables you to see and target PSMA-positive mCRPC12–14

Icon of an arrow on the bulls-eye of a target.

The high sensitivity of PSMA scanning detects PSMA-positive bone, nodal, or visceral metastases13–16


Icon of a magnifying glass.

PSMA imaging establishes patient eligibility for PSMA-targeted RLT1


The most common ADRs (≥20%) occurring at a higher incidence in patients who received Pluvicto + BSoC compared to BSoC alone include: fatigue, dry mouth, nausea, anaemia, decreased appetite and constipation. For the full list of ADRs, please refer to the Pluvicto® Summary of Product Characteristics.

Prescribing information for Locametz®▼ (gozetotide) and adverse event reporting details can be found here.


*In VISION, a randomised, open-label, multicentre, Phase III clinical trial (n=831), Pluvicto prolonged overall survival, imaging-based progression-free survival, and maintained quality of life for longer when used alongside best standard of care compared to best standard of care alone.

Alternate primary endpoints: Overall survival was improved by 4 months vs BSoC (HR 0.62, 95% CI, 0.52–0.74; p<0.001), radiographic progression-free survival was improved by 5.3 months vs BSoC (HR 0.40, 99.2% CI, 0.29–0.57; p<0.001).

Secondary endpoint: Quality of life measured as FACT-P total score was maintained by 3.5 months more vs BSoC (HR 0.54, 95% CI, 0.45–0.66; nominal p-value with non-inferential analysis <0.001), quality of life measured as BPI-SF pain intensity was maintained by 3.7 months more vs BSoC (HR 0.52, 95% CI, 0.43–0.63, nominal p-value with non-inferential analysis <0.001).

ADR, adverse drug reaction; AR, androgen receptor; BPI-SF, brief pain inventory (short form); BSoC, best standard of care; CI, confidence interval; FACT-P, functional assessment of cancer therapy – prostate; HR, hazard ratio; mCRPC, metastatic castration-resistant prostate cancer; PSMA, prostate-specific membrane antigen; RLT, radioligand therapy.


  1. Sartor O, et al. N Engl J Med 2021;385(12):1091–1103.
  2. Pluvicto® Great Britain Summary of Product Characteristics. Available at: [Accessed March 2023].
  3. Kyriakopoulos CE, et al J Clin Oncol. 2018;36(11):1080–1087.
  4. Kirby M, et al. Int J Clin Pract 2011;65(11):1180–1192.
  5. Zhao F, et al. Clin Transl Med 2019;8(1):30.
  6. Fizazi K, et al. Lancet Oncol 2012;13(10):983–992. Erratum in: Lancet Oncol 2012;13(11):e464. Erratum in: Lancet Oncol. 2014;15(9):e365.
  7. Scher HI, et al. N Engl J Med 2012;367(13):1187–1197.
  8. Hoskin P, et al. Lancet Oncol 2014;15(12):1397–1406.
  9. de Wit R, et al. N Engl J Med 2019;381(26):2506–2518.
  10. Sartor O, et al. N Engl J Med 2021;385(12):1091–1103. Supplementary appendix.
  11. Pomykala KL et al, J Nucl Med 2020;61(3):405–411.
  12. Hofman MS, et al. Lancet Oncol 2018;19(6):825–833.
  13. Maffey-Steffan J, et al. Eur J Nucl Med Mol Imaging 2020;47(3):695–712. Erratum in: Eur J Nucl Med Mol Imaging 2019; PMID: 31776632; PMCID: PMC7005064.
  14. Vlachostergios PJ, et al. Front Oncol 2021;11:630589.
  15. Woythal N, et al. J Nucl Med 2018;59(2):238–243.
  16. Schmuck S, et al. J Nucl Med 2017;58(12):1962–1968.
AAA-PSMA-UK-0272 | March 2023

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