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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.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,125 enrolled.
102 vs 143 deaths; median follow-up 34 months; 1125 randomised
Source7 patients
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival at 3 years (Kaplan-Meier)primary | Enzalutamide + testosterone suppression | - | 80% | 0.67 (0.52 to 0.86) | 0.002 | link |
| Standard nonsteroidal antiandrogen + testosterone suppression | - | 72% | ||||
| PSA progression-free survival | Enzalutamide + testosterone suppression | - | 174 events | 0.39 | <0.001 | link |
| Standard nonsteroidal antiandrogen + testosterone suppression | - | 333 events | ||||
| Clinical progression-free survival | Enzalutamide + testosterone suppression | - | 167 events | 0.4 | <0.001 | link |
| Standard nonsteroidal antiandrogen + testosterone suppression | - | 320 events | ||||
| Seizures | Enzalutamide + testosterone suppression | - | 1% | - | - | link |
| Standard nonsteroidal antiandrogen + testosterone suppression | - | 0% |
Shares Prostate cancer drugs in England: what NICE recommends, and what it refuses, Astellas, Enzalutamide, Androgen deprivation & AR pathway inhibitors and the tag subtype-trials.
Shares A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Metastatic hormone-sensitive prostate cancer, Androgen deprivation & AR pathway inhibitors and the tag subtype-trials.
Shares Prostate cancer drugs in England: what NICE recommends, and what it refuses, Androgen deprivation & AR pathway inhibitors, Prostate cancer and the tag subtype-trials.
Shares Docetaxel and the tag subtype-trials.
Shares Pfizer (incl. Seagen) and the tag subtype-trials.
Shares Docetaxel and the tag subtype-trials.
Shares Pfizer (incl. Seagen) and the tag subtype-trials.
Shares Docetaxel and the tag subtype-trials.