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ERLEADA®

(apalutamide)

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ERLEADA® (apalutamide)
Medical Information

ERLEADA - Concomitant Use of ERLEADA With Radioligands

Last Updated: 10/16/2026

SUMMARY

  • ERLEADA has been studied in combination with radioligands, including lutetium 177Lu vipivotide tetraxetan (Lu-177-PSMA-617).
  • Lu-177-PSMA-617 is US FDA-approved in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer, based on the phase 3 PSMAddition (NCT04720157) study.1,2
    • In PSMAddition, patients were randomized 1:1 to receive either Lu-177-PSMA-617 in combination with an ARPI (n=572) or an ARPI alone (n=572). Treatment with an ARPI in both groups could be continued until progressive disease or unacceptable toxicity. Patients also received concurrent gonadotropin-releasing hormone agonist or antagonist or had a bilateral orchiectomy. Administered ARPIs were per investigator’s choice. ERLEADA was used as the first concomitant ARPI in 32.9% (372/1129) of enrolled patients and as a concomitant ARPI at any time in 34.3% (387/1129) of enrolled patients. Results were not delineated per concomitant ARPI.3
  • Additional phase 24,5 and 36 studies and real-world analyses7,8 are evaluating concomitant use of Lu-177-PSMA-617 with standard of care including ARPIs such as ERLEADA; however, results are either not delineated per ARPI or are not available.

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 31 August 2026.

References

Show
1 FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer. Food and Drug Administration (FDA). Accessed 2026-10-13. Available via: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-vipivotide-tetraxetan-androgen-receptor-pathway-inhibitor-therapy
2 Tagawa ST, Sartor O, Piulats JM, et al. [177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial. Lancet. 2026;408(10557):793-807.  
3 Tagawa ST, Sartor O, Piulats JM, et al. Supplement to: [177Lu]Lu-PSMA-617 in patients with PSMA-positive metastatic androgen pathway modulator-naive/sensitive prostate cancer (PSMAddition): a phase 3 randomised, controlled trial. Lancet. 2026;408(10557):793-807.  
4 Novartis Pharmaceuticals. A phase II study of AAA617 alone and AAA617 in combination with ARPI in patients with PSMA PET scan positive CRPC (PSMACare). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 August 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT05849298 NLM Identifier: NCT05849298.  
5 Novartis Pharmaceuticals. An open-label study of lutetium (177Lu) vipivotide tetraxetan (AAA617) in combination with ARPI versus AAA617 in PSMA positive first-line mCRPC (PSMAndARPI). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2026 August 31]. Available from: https://clinicaltrials.gov/ct2/show/NCT06894511 NLM Identifier: NCT06894511.  
6 Sartor O, Bono J de, Chi KN, et al. Lutetium-177–PSMA-617 for metastatic castration-resistant prostate cancer. N Engl J Med. 2021;385(12):1091-1103.  
7 Heath EI, George DJ, Sartor AO, et al. [177Lu]Lu-PSMA-617 (177Lu-PSMA-617) in combination with an androgen receptor pathway inhibitor (ARPI) versus 177Lu-PSMA-617 alone for the treatment of metastatic castration-resistant prostate cancer (mCRPC): a real-world prostate cancer disease observation (PRECISION) data platform analysis [abstract]. J Clin Oncol. 2026;44 (Suppl. 7). Abstract 78.  
8 Muniz M, Sartor O, Orme JJ, et al. Outcomes for [177Lu]Lu-PSMA-617 with and without concurrent use of androgen receptor pathway inhibitors in patients with metastatic castration-resistant prostate cancer. Eur Urol Oncol. 2025;8(4):1087-1093.  

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