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Randomised phase 2 BULLSEYE trial: ¹⁷⁷Lu-PSMA-617 in oligometastatic HSPC

Long-term outcomes and delayed toxic effects remain under investigation, but investigators report the trial suggests ¹⁷⁷Lu-PSMA-617 could delay disease progression in high-risk oligometastatic hormone-sensitive prostate cancer.

  • Bastiaan M Privé, MD PhD; Walter Noordzij, MD PhD; Constantijn H J Muselaers, MD PhD; Igle J de Jong, MD PhD; Inge M van Oort, MD PhD; Marcel J R Janssen, MD PhD; et al.

  • April 1, 2026

  • The Lancet Oncology
  • The Lancet Oncology, Volume 27, Issue 4, Pages 461–469
  • 10.1016/S1470-2045(25)00762-4

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Evidence before this study

We searched PubMed and MEDLINE using the MeSH terms “lutetium” AND “prostate-specific membrane antigen,” AND “prostatic neoplasms” for studies from database inception up to the finalisation of the protocol on Feb 20, 2020, with no language restrictions. Although some retrospective cohorts and single-arm studies reported encouraging outcomes in patients with end-stage castration resistant prostate cancer, there were no prospective randomised studies reported at that time investigating the use of Lu-PSMA-617 in prostate cancer, particularly not in those with hormone-sensitive or oligometastatic disease. Therefore, we initiated a randomised phase 2 trial using the results of our phase 1 study. The trial design was based on previous randomised studies evaluating metastases-directed therapies (eg, external beam radiotherapy or surgery) in oligometastatic prostate cancer.

Added value of this study

To our knowledge, this randomised phase 2 study is the first to apply Lu-PSMA-617 in high-risk oligometastatic hormone-sensitive prostate cancer (HSPC) and shows that Lu-PSMA-617 effectively delays disease progression, with treatment being well tolerated and health-related quality of life being maintained. Moreover, the study provides preliminary evidence that receptor-targeted radionuclide therapy could result in durable remissions.

Implications of all the available evidence

The findings from the BULLSEYE trial, along with results from other studies, suggest that after surgery and radiotherapy, Lu-PSMA-617 could offer an additional treatment option for patients with oligometastatic HSPC to delay disease progression and thereby initiation of androgen deprivation therapy. However, long-term outcomes, including delayed toxic effects, require further investigation, along with improvements in patient selection.

Source: The Lancet Oncology

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