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Moved enzalutamide in front of chemotherapy, cutting the risk of the cancer showing on scans by four fifths and the risk of death by a third.
PREVAIL randomised 1,717 men with metastatic castration-resistant prostate cancer who had not had chemotherapy to enzalutamide 160 mg daily or placebo. It was stopped at a planned interim analysis after 540 deaths.
Radiographic progression-free survival at 12 months was 65 percent with enzalutamide against 14 percent with placebo, an 81 percent risk reduction, hazard ratio 0.19 (95 percent confidence interval 0.15 to 0.23, p<0.001). At the data cutoff, 626 of the enzalutamide group (72 percent) and 532 of the placebo group (63 percent) were alive, hazard ratio for death 0.71 (0.60 to 0.84, p<0.001).
Secondary endpoints all favoured enzalutamide: time to starting cytotoxic chemotherapy (hazard ratio 0.35), time to first skeletal-related event (0.72), complete or partial soft-tissue response (59 against 5 percent), time to PSA progression (0.17) and a PSA decline of at least 50 percent (78 against 3 percent), all p<0.001. Fatigue and hypertension were the most common clinically relevant adverse events.
In England NICE TA377 recommends enzalutamide within its marketing authorisation for metastatic hormone-relapsed prostate cancer in men with no or mild symptoms after androgen deprivation has failed and before chemotherapy is indicated, with the patient access scheme discount.
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.
1,717 enrolled.
72 percent alive at data cutoff · 63 percent alive at data cutoff
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survival at 12 monthsprimary | Enzalutamide 160 mg daily | - | 65% | 0.19 (0.15 to 0.23) | <0.001 | link |
| Placebo | - | 14% | ||||
| Overall survivalprimary | Enzalutamide 160 mg daily | - | 72 percent alive at data cutoff | 0.71 (0.6 to 0.84) | <0.001 | link |
| Placebo | - | 63 percent alive at data cutoff | ||||
| PSA decline of 50 percent or more | Enzalutamide 160 mg daily | - | 78% | - | <0.001 | link |
| Placebo | - | 3% |
Shares COU-AA-302, AFFIRM, PSA50 / PSA90 response, Androgen receptor pathway inhibitor (ARPI).
Shares ARMOR3-SV, Androgen receptor pathway inhibitor (ARPI), Castration-resistant prostate cancer (CRPC), Androgen receptor.
Shares AFFIRM, Androgen receptor pathway inhibitor (ARPI), What follows what in castration-resistant prostate cancer, Enzalutamide.
Shares Androgen receptor pathway inhibitor (ARPI), What follows what in castration-resistant prostate cancer, Enzalutamide, Castration-resistant prostate cancer (CRPC).
Shares COU-AA-302, Androgen receptor pathway inhibitor (ARPI), Castration-resistant prostate cancer (CRPC), Androgen deprivation & AR pathway inhibitors.
Shares Androgen receptor pathway inhibitor (ARPI), Enzalutamide, Castration-resistant prostate cancer (CRPC), Androgen receptor.
Shares Enzalutamide, Androgen deprivation & AR pathway inhibitors, Pfizer (incl. Seagen), Metastatic castration-resistant prostate cancer.
Shares Astellas, Enzalutamide, Androgen deprivation & AR pathway inhibitors, Prostate cancer.