# ENZAMET

Source: https://onco.cc/trials/enzamet/  
OnCo record `enzamet` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ENZAMET showed that adding enzalutamide to hormone therapy from the moment prostate cancer is found to have spread helped men live longer, and it did so in an academic trial that also allowed chemotherapy, which made its results widely applicable.

## Summary

ENZAMET, run by the Australian and New Zealand ANZUP group with the Canadian Cancer Trials Group and others, randomised 1125 men with metastatic hormone-sensitive prostate cancer to testosterone suppression with enzalutamide or with a conventional non-steroidal antiandrogen (bicalutamide, nilutamide or flutamide). Early docetaxel was permitted at the investigator's discretion and stratified for. The primary endpoint was overall survival.

Enzalutamide improved overall survival, with the benefit clearest in men who did not receive docetaxel and in low-volume disease, and the advantage persisted in the long-term analysis. Alongside ARCHES, TITAN, LATITUDE and STAMPEDE it made intensified hormone therapy the standard for newly metastatic disease.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Also known as: ANZUP 1304
- Tags: subtype-trials
- Registry id: NCT02446405
- Phase: 3
- Setting: Metastatic hormone-sensitive prostate cancer: testosterone suppression with enzalutamide against testosterone suppression with a standard non-steroidal antiandrogen, with docetaxel allowed in both arms
- Sponsor: University of Sydney (ANZUP Cancer Trials Group)
- Enrolled: 1125
- Result: Enzalutamide added to testosterone suppression improved overall survival compared with a standard non-steroidal antiandrogen.
- Outcomes: Overall survival at 3 years (Kaplan-Meier): Enzalutamide + testosterone suppression 80% vs Standard nonsteroidal antiandrogen + testosterone suppression 72%, HR 0.67; PSA progression-free survival: Enzalutamide + testosterone suppression vs Standard nonsteroidal antiandrogen + testosterone suppression, HR 0.39; Clinical progression-free survival: Enzalutamide + testosterone suppression vs Standard nonsteroidal antiandrogen + testosterone suppression, HR 0.4; Seizures: Enzalutamide + testosterone suppression 1% vs Standard nonsteroidal antiandrogen + testosterone suppression 0%

## Notes

- In England NICE TA712 recommends enzalutamide with androgen deprivation within its marketing authorisation for hormone-sensitive metastatic prostate cancer, subject to the commercial arrangement, with no restriction to men who cannot have docetaxel. The committee's stated reasoning was that enzalutamide is taken by mouth and so more convenient than intravenous docetaxel, that it lengthens the time until progression and how long people live compared with androgen deprivation alone, and that an indirect comparison suggests longer time to progression than docetaxel plus androgen deprivation although the survival comparison is unclear.

## Sources

- ClinicalTrials.gov NCT02446405: https://clinicaltrials.gov/study/NCT02446405
- NICE TA712: enzalutamide for treating hormone-sensitive metastatic prostate cancer: https://www.nice.org.uk/guidance/ta712

## Connected records

- cancers: [Metastatic hormone-sensitive prostate cancer](https://onco.cc/cancers/prostate-mhspc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Androgen deprivation & AR pathway inhibitors](https://onco.cc/technologies/androgen-deprivation/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Enzalutamide](https://onco.cc/drugs/enzalutamide/)
- companies: [Astellas](https://onco.cc/companies/astellas/), [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- terms: [Prostate cancer drugs in England: what NICE recommends, and what it refuses](https://onco.cc/terms/prostate-uk-drug-approvals/)
- trials: [A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC](https://onco.cc/trials/nct02489318/), [ARCHES](https://onco.cc/trials/arches/), [KEYNOTE-991](https://onco.cc/trials/keynote-991/)
- people: [Ian Davis](https://onco.cc/people/ian-davis/)
- key papers: [Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer](https://onco.cc/key-papers/paper-enzamet-n-engl-j-med-2019/)

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