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PROSPER showed that enzalutamide delayed the appearance of metastases by about two years, and later helped men live longer, when given at the point where prostate cancer is rising on hormone therapy but has not yet spread on scans.
PROSPER randomised 1401 men with castration-resistant prostate cancer, no metastases on conventional imaging and a PSA doubling time of ten months or less two to one to enzalutamide or placebo alongside androgen deprivation. The primary endpoint was metastasis-free survival.
Enzalutamide lengthened metastasis-free survival substantially and delayed the time to PSA progression and to further antineoplastic therapy; with longer follow-up overall survival was also improved. Fatigue, hypertension and falls were the main added toxicities. It was approved for this indication in July 2018 and, with SPARTAN (apalutamide) and ARAMIS (darolutamide), defined androgen receptor pathway inhibition as the standard for high-risk non-metastatic castration-resistant disease, a group that PSMA PET imaging has since shrunk.
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.
1,401 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Metastasis-free survivalprimary | Enzalutamide | 933 | 36.6 months | 0.29 (0.24 to 0.35) | <0.001 | link |
| Placebo | 468 | 14.7 months | ||||
| Time to PSA progression | Enzalutamide | 933 | 37.2 months | 0.07 | <0.001 | link |
| Placebo | 468 | 3.9 months | ||||
| Time to first subsequent antineoplastic therapy | Enzalutamide | 933 | 39.6 months | 0.21 | <0.001 | link |
| Placebo | 468 | 17.7 months | ||||
| Grade 3 or higher adverse events | Enzalutamide | - | 31% | - | - | link |
| Placebo | - | 23% |
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 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 Pfizer (incl. Seagen) and the tag subtype-trials.
Shares Pfizer (incl. Seagen) and the tag subtype-trials.
Shares Pfizer (incl. Seagen) and the tag subtype-trials.
Shares Pfizer (incl. Seagen) and the tag subtype-trials.
Shares Metastasis-free survival (MFS), Prostate cancer drugs in England: what NICE recommends, and what it refuses, Astellas, Enzalutamide.
Shares Astellas, Enzalutamide, Androgen deprivation & AR pathway inhibitors, Prostate cancer.