# PREVAIL

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

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: PREVAIL; MDV3100-04
- Registry id: NCT01212991
- Phase: 3
- Setting: Metastatic castration-resistant prostate cancer progressing despite androgen deprivation and not yet treated with chemotherapy: enzalutamide 160 mg daily against placebo, with co-primary endpoints of radiographic progression-free survival and overall survival
- Sponsor: Medivation and Astellas
- Enrolled: 1717
- Result: Radiographic progression-free survival at 12 months 65 against 14 percent (hazard ratio 0.19, 95 percent confidence interval 0.15 to 0.23) and hazard ratio for death 0.71 (0.60 to 0.84) before chemotherapy.
- Outcomes: Radiographic progression-free survival at 12 months: Enzalutamide 160 mg daily 65% vs Placebo 14%, HR 0.19; Overall survival: Enzalutamide 160 mg daily vs Placebo, HR 0.71; PSA decline of 50 percent or more: Enzalutamide 160 mg daily 78% vs Placebo 3%
- Replication: COU-AA-302 found the same for abiraterone before chemotherapy in 1,088 men.

## Sources

- ClinicalTrials.gov NCT01212991: https://clinicaltrials.gov/study/NCT01212991
- PREVAIL (New England Journal of Medicine 2014): https://doi.org/10.1056/NEJMoa1405095
- NICE TA377: enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated: https://www.nice.org.uk/guidance/ta377

## Connected records

- cancers: [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [Androgen deprivation & AR pathway inhibitors](https://onco.cc/technologies/androgen-deprivation/)
- targets: [Androgen receptor](https://onco.cc/targets/androgen-receptor/)
- drugs: [Enzalutamide](https://onco.cc/drugs/enzalutamide/)
- companies: [Astellas](https://onco.cc/companies/astellas/), [Pfizer (incl. Seagen)](https://onco.cc/companies/pfizer/)
- terms: [Androgen receptor pathway inhibitor (ARPI)](https://onco.cc/terms/arpi/), [Castration-resistant prostate cancer (CRPC)](https://onco.cc/terms/castration-resistance/), [PSA50 / PSA90 response](https://onco.cc/terms/psa50/), [What follows what in castration-resistant prostate cancer](https://onco.cc/terms/prostate-crpc-sequencing/)
- trials: [AFFIRM](https://onco.cc/trials/affirm/), [ARMOR3-SV](https://onco.cc/trials/armor3-sv/), [COU-AA-302](https://onco.cc/trials/cou-aa-302/)

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