NCT04419402: ENZA-p

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

Status unknown Phase 2 Last updated 7 February 2024

What this trial tests

Phase 2 trial testing Lu-PSMA in Metastatic Castration-Resistant Prostate Cancer in 162 participants. Status unknown.

Timeline

17 August 2020

Primary endpoint
31 July 2024

1 January 2025

Quick facts

Lead sponsor	Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	162
Start date	17 August 2020
Primary completion	31 July 2024
Estimated completion	1 January 2025
Sites	15 locations across Australia

Drugs / interventions tested

• Lu-PSMA — full drug profile →
• Enzalutamide (enzalutamide) — full drug profile →

Conditions studied

• Metastatic Castration-Resistant Prostate Cancer — all drugs for Metastatic Castration-Resistant Prostate Cancer →

Sponsor

Australian and New Zealand Urogenital and Prostate Cancer Trials Group — full company profile →

Who can join

18 and older, male only, with Metastatic Castration-Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Radiotheranostics in oncology: current challenges and emerging opportunities.
   Bodei L, Herrmann K, Schöder H, Scott AM, et al · · 2022 · cited 251× · PMID 35725926 · DOI 10.1038/s41571-022-00652-y
2. <sup>177</sup>Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial.
   Morris MJ, Castellano D, Herrmann K, de Bono JS, et al · · 2024 · cited 170× · PMID 39293462 · DOI 10.1016/s0140-6736(24)01653-2
3. [<sup>177</sup>Lu]Lu-PSMA-617 plus enzalutamide in patients with metastatic castration-resistant prostate cancer (ENZA-p): an open-label, multicentre, randomised, phase 2 trial.
   Emmett L, Subramaniam S, Crumbaker M, Nguyen A, et al · · 2024 · cited 104× · PMID 38621400 · DOI 10.1016/s1470-2045(24)00135-9
4. Targeted Therapy for Cancers: From Ongoing Clinical Trials to FDA-Approved Drugs.
   Choi HY, Chang JE. · · 2023 · cited 77× · PMID 37686423 · DOI 10.3390/ijms241713618
5. Status of PSMA-targeted radioligand therapy in prostate cancer: current data and future trials.
   Jang A, Kendi AT, Sartor O. · · 2023 · cited 63× · PMID 36895851 · DOI 10.1177/17588359231157632
6. Lutetium Lu 177 Vipivotide Tetraxetan: First Approval.
   Keam SJ. · · 2022 · cited 62× · PMID 35553387 · DOI 10.1007/s40291-022-00594-2
7. Peptide Drug Conjugates and Their Role in Cancer Therapy.
   Heh E, Allen J, Ramirez F, Lovasz D, et al · · 2023 · cited 54× · PMID 36614268 · DOI 10.3390/ijms24010829
8. PSMA-Targeted Radiopharmaceuticals in Prostate Cancer: Current Data and New Trials.
   Ramnaraign B, Sartor O. · · 2023 · cited 49× · PMID 36806966 · DOI 10.1093/oncolo/oyac279