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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.
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.
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.
1,088 enrolled.
not reached Did not cross the prespecified efficacy boundary at the interim analysis.
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survival (median)primary | Abiraterone acetate with prednisone | - | 16.5 months | 0.53 (0.45 to 0.62) | <0.001 | link |
| Placebo with prednisone | - | 8.3 months | ||||
| Overall survival (median)primary | Abiraterone acetate with prednisone | - | not reached Did not cross the prespecified efficacy boundary at the interim analysis. | 0.75 (0.61 to 0.93) | 0.01 | link |
| Placebo with prednisone | - | 27.2 months |
Shares COU-AA-301, PREVAIL, Androgen receptor pathway inhibitor (ARPI), What follows what in castration-resistant prostate cancer.
Shares ELM-PC 4, Androgen receptor pathway inhibitor (ARPI), Castration-resistant prostate cancer (CRPC), Metastatic castration-resistant prostate cancer.
Shares Androgen receptor pathway inhibitor (ARPI), What follows what in castration-resistant prostate cancer, Abiraterone acetate, Prednisone.
Shares Abiraterone acetate, Prednisone, Androgen deprivation & AR pathway inhibitors, Metastatic castration-resistant prostate cancer.
Shares Abiraterone acetate, Prednisone, Androgen deprivation & AR pathway inhibitors, Johnson & Johnson.
Shares PREVAIL, Androgen receptor pathway inhibitor (ARPI), Castration-resistant prostate cancer (CRPC), Androgen receptor.
Shares Androgen receptor pathway inhibitor (ARPI), Castration-resistant prostate cancer (CRPC), Androgen receptor, Metastatic castration-resistant prostate cancer.
Shares Androgen receptor pathway inhibitor (ARPI), What follows what in castration-resistant prostate cancer, Castration-resistant prostate cancer (CRPC), Androgen deprivation & AR pathway inhibitors.