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Blocking the survival protein clusterin did not make chemotherapy work better for advanced prostate cancer.
SYNERGY randomised 1,022 men with chemotherapy-naive metastatic castration-resistant prostate cancer to docetaxel and prednisone with or without custirsen, an antisense oligonucleotide against the chaperone protein clusterin. Randomisation was stratified by opioid use for cancer-related pain and by radiographic evidence of progression.
Median overall survival was 23.4 months (95 percent confidence interval 20.9 to 24.8) with custirsen and 22.0 months (19.5 to 24.0) without, hazard ratio 0.93 (0.79 to 1.10, p=0.415).
The commonest grade 3 or worse events with custirsen against control were neutropenia (grade 3 in 13 against 6 percent, grade 4 in 20 against 15 percent), febrile neutropenia (grade 3 in 10 against 6 percent) and fatigue (grade 3 in 11 against 8 percent). Serious adverse events were reported for 214 of 501 men (43 percent) on custirsen and 181 of 499 (36 percent) on control, and adverse events were attributed to 23 and 24 deaths respectively.
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.
1,022 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Docetaxel, prednisone and custirsen | 510 | 23.4 months | 0.93 (0.79 to 1.1) | 0.415 | link |
| Docetaxel and prednisone | 512 | 22 months |
Shares TAX 327, Prostate cancer programmes that failed, and what each failure taught, Prednisone, Castration-resistant prostate cancer (CRPC).
Shares TAX 327, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares TAX 327, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares AFFINITY, TAX 327, Prednisone, Castration-resistant prostate cancer (CRPC).
Shares Prostate cancer programmes that failed, and what each failure taught, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares Prostate cancer programmes that failed, and what each failure taught, Prednisone, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares TAX 327, Prostate cancer programmes that failed, and what each failure taught, Castration-resistant prostate cancer (CRPC), Docetaxel.
Shares Prednisone, Docetaxel, Metastatic castration-resistant prostate cancer, Prostate cancer.