Enzalutamide With Lu PSMA-617 Versus Enzalutamide Alone in Men With Metastatic Castration-resistant Prostate Cancer

Summary

This phase 2 randomised clinical trial will investigate the activity and safety of adding Lu-PSMA to enzalutamide in patients with metastatic castrate resistant prostate cancer (mCRPC) not previously treated with chemotherapy.

Timeline

Start

2020-08-17

Primary completion

2024-04-12

Completion

2026-12-01

Publications

• Ayati N, Papa N, Crumbaker M, Subramaniam S, Joshua AM, Alipour R, Iravani A, Askari E, Khan S, Yadav S, Eiber M, Weickhardt A, Lee ST, Ng S, Francis RJ, Goh JC, Pattison DA, Tan TH, Kirkwood ID, Nguyen A, Hofman MS, Sandhu S, Hioki T, van Oorschodt JCJ, Devitt K, Willowson K, Sharma S, Stancu A, Chauvie S, Wilson P, Martin AJ, Thomas H, Stockler MR, Davis ID, Emmett L; Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group. 177Lu-PSMA-617 SPECT/CT for Early Prediction of Overall Survival in Participants with Metastatic Castration-Resistant Prostate Cancer. Radiology. 2026 Apr;319(1):e252672. doi: 10.1148/radiol.252672.
• Emmett L, Swiha M, Papa N, Subramaniam S, Crumbaker M, Joshua AM, Nguyen A, Weickhardt A, Lee ST, Ng S, Francis RJ, Goh JC, Pattison DA, Pathmanandavel S, Hope T, Ayati N, Hofman MS, Sandhu S, Niu C, Martin AJ, Thomas H, Stockler MR, Davis ID; Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group. Predictive value of early PSMA upregulation for the response to enzalutamide +/- 177Lu-PSMA-617 in poor-risk, metastatic, castration-resistant prostate cancer: substudy of the randomized, phase 2 ENZA-p trial. Nat Cancer. 2026 Apr;7(4):622-630. doi: 10.1038/s43018-026-01140-3. Epub 2026 Apr 15.
• Emmett L, Papa N, Sartor O, Morris MJ, Subramaniam S, Crumbaker M, Ayati N, Chen J, Herrmann K, Gafita A, Swiha M, Joshua AM, Weickhardt A, Lee ST, Ng S, Francis RJ, Goh JC, Pattison DA, Ho B, Khan S, Tan TH, Bills M, Nguyen A, Thein T, Sidhom G, Wong K, Martin AJ, Hofman MS, Sandhu S, Thomas H, Stockler MR, Davis ID; ENZA-p Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Prognostic Value of Interim PSMA-PET Total Tumor Volume for Overall Survival Within ENZA-p, A Randomized Phase 2 Trial of Enzalutamide Versus Enzalutamide Plus [177Lu] Lu-PSMA-617 (ANZUP1901). Eur Urol. 2026 Apr 8:S0302-2838(26)02063-4. doi: 10.1016/j.eururo.2026.03.026. Online ahead of print.
• Emmett L, Papa N, Subramaniam S, Crumbaker M, Nguyen A, Joshua AM, Sandhu S, Weickhardt A, Lee ST, Ng S, Francis RJ, Goh JC, Pattison DA, Tan TH, Kirkwood ID, Ayati N, Niu C, Hofman MS, Martin AJ, Thomas H, Davis ID, Stockler MR; ENZA-p Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Prognostic and predictive value of baseline PSMA-PET total tumour volume and SUVmean in metastatic castration-resistant prostate cancer in ENZA-p (ANZUP1901): a substudy from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Sep;26(9):1168-1177. doi: 10.1016/S1470-2045(25)00339-0. Epub 2025 Jul 30.
• Emmett L, Subramaniam S, Crumbaker M, Joshua AM, Sandhu S, Nguyen A, Weickhardt A, Lee ST, Ng S, Francis RJ, Goh JC, Pattison DA, Tan TH, Kirkwood ID, Gedye C, Rutherford NK, Kumar ASR, Pook D, Ramdave S, Nadebaum DP, Voskoboynik M, Redfern AD, Macdonald W, Krieger L, Schembri G, Chua W, Lin P, Horvath L, Bastick P, Butler P, Zhang AY, McJannett M, Thomas H, Langford A, Hofman MS, Martin AJ, Davis ID, Stockler MR; ENZA-p Trial Investigators; Australian and New Zealand Urogenital and Prostate Cancer Trials Group. Overall survival and quality of life with [177Lu]Lu-PSMA-617 plus enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer (ENZA-p): secondary outcomes from a multicentre, open-label, randomised, phase 2 trial. Lancet Oncol. 2025 Mar;26(3):291-299. doi: 10.1016/S1470-2045(25)00009-9. Epub 2025 Feb 13.
• Emmett L, Subramaniam S, Crumbaker M, Nguyen A, Joshua AM, Weickhardt A, Lee ST, Ng S, Francis RJ, Goh JC, Pattison DA, Tan TH, Kirkwood ID, Gedye C, Rutherford NK, Sandhu S, Kumar AR, Pook D, Ramdave S, Nadebaum DP, Voskoboynik M, Redfern AD, Macdonald W, Krieger L, Schembri G, Chua W, Lin P, Horvath L, Bastick P, Butler P, Zhang AY, Yip S, Thomas H, Langford A, Hofman MS, McJannett M, Martin AJ, Stockler MR, Davis ID; ENZA-p Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. [177Lu]Lu-PSMA-617 plus enzalutamide in patients with metastatic castration-resistant prostate cancer (ENZA-p): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2024 May;25(5):563-571. doi: 10.1016/S1470-2045(24)00135-9. Epub 2024 Apr 12.

Drugs

Indications