CHAARTED (E3805)

CHAARTED, ECOG-ACRIN trial E3805, NCT00309985, reported in 2015, was the first trial to show that giving docetaxel at the start of hormone therapy prolongs life in metastatic hormone-sensitive prostate cancer. It randomised 790 men to androgen deprivation with or without docetaxel and met its primary overall survival endpoint, but in long-term follow-up the benefit was confined to men with high-volume disease. OnCo links it to prostate cancer, docetaxel and Christopher J. Sweeney, and the result was replicated by arm C of the STAMPEDE platform, with the concentration of benefit in high-volume disease shaping how that distinction is used. Whether chemotherapy still earns its place now that triplet regimens and PSMA radioligands have entered this setting is the open question. Docetaxel has its own page.

Setting

Metastatic hormone-sensitive prostate cancer: ADT + docetaxel vs ADT

Phase

Phase 3

Sponsor

ECOG-ACRIN

Registry

NCT00309985

Headline result

OS HR 0.61 overall; high-volume HR 0.63; low-volume no benefit.

Started

2006-09-26

Reported

2015

Enrolled

790 enrolled

Replication

Replicated by STAMPEDE arm C; benefit concentrated in high-volume disease.

Outcomes

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In plain words

What these results mean for people, not percentages

790 enrolled

Overall survivalprimarysurvival endpoint

Median 57.6 vs 44 months with ADT + docetaxel compared with ADT alone; about 13.6 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 39 percent lower chance of the event at any given time (hazard ratio 0.61, likely range 0.47 to 0.8).

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Overall survival (median)primarysurvival endpoint

Median 57.6 vs 44 months with Androgen deprivation with docetaxel compared with Androgen deprivation alone; about 13.6 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 39 percent lower chance of the event at any given time (hazard ratio 0.61, likely range 0.47 to 0.8).

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Time to biochemical, symptomatic or radiographic progression (median)other endpoint

Median 20.2 vs 11.7 months with Androgen deprivation with docetaxel compared with Androgen deprivation alone; about 8.5 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 39 percent lower chance of the event at any given time (hazard ratio 0.61, likely range 0.51 to 0.72).

This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.

Caveats

These results apply to the people the trial enrolled: Metastatic hormone-sensitive prostate cancer: ADT + docetaxel vs ADT. People in a different situation may not see the same effect.

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.

790 enrolled.

Overall survivalprimary

HR 0.61 (0.47 to 0.8) · p <0.001

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Source

Overall survival (median)primary

HR 0.61 (0.47 to 0.8) · p <0.001

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Source

Time to biochemical, symptomatic or radiographic progression (median)

HR 0.61 (0.51 to 0.72) · p <0.001

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Source

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Overall survivalprimary	ADT + docetaxel	397	57.6 months	0.61 (0.47 to 0.8)	<0.001	link
Overall survivalprimary	ADT alone	393	44 months	0.61 (0.47 to 0.8)	<0.001	link
Overall survival (median)primary	Androgen deprivation with docetaxel	-	57.6 months	0.61 (0.47 to 0.8)	<0.001	link
Overall survival (median)primary	Androgen deprivation alone	-	44 months	0.61 (0.47 to 0.8)	<0.001	link
Time to biochemical, symptomatic or radiographic progression (median)	Androgen deprivation with docetaxel	-	20.2 months	0.61 (0.51 to 0.72)	<0.001	link
	Androgen deprivation alone	-	11.7 months	0.61 (0.51 to 0.72)	<0.001	link

Replication

Replicated by STAMPEDE arm C; benefit concentrated in high-volume disease.

Notes

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CHAARTED randomised 790 men, median age 63, to androgen deprivation with or without docetaxel 75 mg/m2 every 3 weeks for six cycles. At a median 28.9 months, median overall survival was 13.6 months longer with the combination, 57.6 against 44.0 months. A PSA below 0.2 ng/mL at 12 months was reached by 27.7 against 16.8 percent (p<0.001). In the combination group grade 3 or 4 febrile neutropenia occurred in 6.2 percent, grade 3 or 4 infection with neutropenia in 2.3 percent and grade 3 sensory and motor neuropathy in 0.5 percent each (New England Journal of Medicine 2015).
GETUG-AFU 15, with 385 men, had tested the same question first and found nothing (hazard ratio 1.01). The difference is sample size and metastatic volume, and the pair is the standard example in prostate cancer of a negative trial that was simply too small.

Key papers

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rctNew England Journal of Medicine 2015changed practice2,127 citations

CHAARTED: chemohormonal therapy in metastatic hormone-sensitive prostate cancer

Docetaxel with androgen deprivation is a standard for high-volume metastatic hormone-sensitive prostate cancer, now usually combined with an androgen receptor pathway inhibitor as triplet therapy.

Connected

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cancers

Metastatic hormone-sensitive prostate cancer Prostate cancer

technologies

Cytotoxic chemotherapy

drugs

ApprovedCytotoxic chemotherapy (taxane)

Docetaxel · Taxotere (generic)

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