# COU-AA-302

Source: https://onco.cc/trials/cou-aa-302/  
OnCo record `cou-aa-302` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Moved abiraterone in front of chemotherapy, doubling the time before scans showed the cancer growing and putting off the day chemotherapy and opiates were needed.

## Summary

COU-AA-302 randomised 1,088 men with metastatic castration-resistant prostate cancer and no previous chemotherapy to abiraterone acetate 1000 mg with prednisone or placebo with prednisone. The study was unblinded after a planned interim analysis at 43 percent of expected deaths.

Median radiographic progression-free survival was 16.5 months with abiraterone against 8.3 months with prednisone alone, hazard ratio 0.53 (95 percent confidence interval 0.45 to 0.62, p<0.001). Over a median 22.2 months, overall survival was improved, median not reached against 27.2 months, hazard ratio 0.75 (0.61 to 0.93, p=0.01), but did not cross the prespecified efficacy boundary at that analysis.

The endpoints that describe daily life all favoured abiraterone: time to starting cytotoxic chemotherapy, time to opiate use for cancer-related pain, time to PSA progression and time to decline in performance status. Grade 3 or 4 mineralocorticoid-related adverse events and liver function abnormalities were more common with abiraterone.

In England NICE TA387 recommends abiraterone with prednisone or prednisolone for metastatic hormone-relapsed prostate cancer in men with no or mild symptoms after androgen deprivation has failed and before chemotherapy is indicated, subject to the commercial access arrangement.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-25
- Also known as: COU-AA-302; abiraterone before chemotherapy
- Registry id: NCT00887198
- Phase: 3
- Setting: Metastatic castration-resistant prostate cancer with no previous chemotherapy: abiraterone acetate 1000 mg with prednisone 5 mg twice daily against placebo with prednisone, with co-primary endpoints of radiographic progression-free survival and overall survival
- Sponsor: Janssen Research and Development, formerly Cougar Biotechnology
- Enrolled: 1088
- Result: Median radiographic progression-free survival 16.5 against 8.3 months (hazard ratio 0.53, 95 percent confidence interval 0.45 to 0.62) and overall survival not reached against 27.2 months (0.75, 0.61 to 0.93) before chemotherapy.
- Outcomes: Radiographic progression-free survival (median): Abiraterone acetate with prednisone 16.5 months vs Placebo with prednisone 8.3 months, HR 0.53; Overall survival (median): Abiraterone acetate with prednisone vs Placebo with prednisone 27.2 months, HR 0.75
- Replication: PREVAIL found the same for enzalutamide before chemotherapy in 1,717 men, with an overall survival hazard ratio of 0.71.

## Sources

- ClinicalTrials.gov NCT00887198: https://clinicaltrials.gov/study/NCT00887198
- COU-AA-302 (New England Journal of Medicine 2013): https://doi.org/10.1056/NEJMoa1209096
- NICE TA387: abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated: https://www.nice.org.uk/guidance/ta387

## 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: [Abiraterone acetate](https://onco.cc/drugs/abiraterone/), [Prednisone](https://onco.cc/drugs/prednisone/)
- companies: [Johnson & Johnson](https://onco.cc/companies/johnson-johnson/)
- terms: [Androgen receptor pathway inhibitor (ARPI)](https://onco.cc/terms/arpi/), [Castration-resistant prostate cancer (CRPC)](https://onco.cc/terms/castration-resistance/), [What follows what in castration-resistant prostate cancer](https://onco.cc/terms/prostate-crpc-sequencing/)
- trials: [COU-AA-301](https://onco.cc/trials/cou-aa-301/), [ELM-PC 4](https://onco.cc/trials/elm-pc-4-orteronel/), [PREVAIL](https://onco.cc/trials/prevail/)

---
JSON: https://onco.cc/api/v1/entities/cou-aa-302.json