ENZA-p

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Official title

ENZA-p: A Randomised Phase II Trial Using PSMA as a Therapeutic Agent and Prognostic Indicator in Men With Metastatic Castration-resistant Prostate Cancer Treated With Enzalutamide (ANZUP 1901)

Phase

Phase 2

Status

Active not recruiting

Conditions

Metastatic Castration-Resistant Prostate Cancer

Interventions

Lu-PSMA; Enzalutamide

Arms

• Lu-PSMA + Enzalutamide · Experimental
• Enzalutamide · Active comparator

Enrollment

162

Primary outcomes

• Prostate Specific Antigen (PSA) Progression-Free Survival

Sponsor

Australian and New Zealand Urogenital and Prostate Cancer Trials Group with National Health and Medical Research Council, Clinical Trials Centre, Prostate Cancer Research Alliance, Endocyte, Astellas Pharma Inc

Start

Aug 17, 2020

Primary completion

Apr 12, 2024

Results posted

No

Registry record

NCT04419402 · updated Jun 22, 2026

• 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. PubMed 42048586
• 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. PubMed 41986500
• 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. PubMed 41956861
• 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. PubMed 40752515
• 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. PubMed 39956124
• 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. PubMed 38621400