In this longer follow-up, adding six cycles of docetaxel chemotherapy to hormone therapy in men with widespread (high-volume) prostate cancer increased median survival by about 17 months; but in low-volume disease no survival benefit was seen.
Metastatic hormone-sensitive prostate cancer (outside the FDA label)
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Docetaxel | 75 mg/m² | IV | Day 1, every 21 days |
| Androgen deprivation therapy (ADT) | As scheduled | Continuous |
Dose from the CHAARTED trial. In ARASENS, darolutamide 600 mg twice daily was added to ADT and docetaxel.
Metastatic hormone-sensitive prostate cancer, especially high-volume
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Docetaxel | 75 mg/m² | IV | Day 1 |
| Hormone therapy (ADT) | Continuous |
As in CHAARTED. Today it is usually given with a newer hormonal tablet (darolutamide or abiraterone).
Dose source:.
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
ADT (LHRH agonist or antagonist, or surgical castration) with docetaxel 75 mg/m² IV over 1 hour on day 1 every 3 weeks (21 days) for 6 cycles, with oral dexamethasone premedication 8 mg at 12, 3 and 1 hours before the infusion; daily prednisone was not required and growth factor was at the physician's discretion.
ADT (LHRH agonist or antagonist, or surgical castration) alone.
Source of the regimen details: Full text of the original report (PMC4562797) and ClinicalTrials.gov NCT00309985
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
790 men with metastatic hormone-sensitive prostate cancer who had started ADT no more than 120 days before randomisation (without evidence of progression); ECOG performance status 0 to 2 (2 only if due to cancer), neutrophils ≥1500, platelets ≥100 thousand, bilirubin ≤ upper limit of normal, ALT ≤2.5 times the upper limit, creatinine clearance ≥30 mL/min. Prior adjuvant ADT (no more than 24 months and completed at least 12 months earlier) was allowed. Stratified by disease volume; high volume = visceral metastases or 4 or more bone lesions with at least one outside the vertebral column and pelvis.
Primary endpoint: overall survival; analyses of the prespecified low-volume and high-volume subgroups.
No new safety data are presented in this long-term report. In the original report, the combination group had grade 3 or 4 febrile neutropenia in 6.2%, grade 3 or 4 infection with neutropenia in 2.3%, and grade 3 sensory and motor neuropathy in 0.5% each.
This analysis showed that the benefit of docetaxel with ADT is confined to high-volume disease. Today the ESMO 2026 guideline generally does not recommend ADT + docetaxel without an ARPI and, in de novo high-volume disease, prefers triplet therapy (ADT + docetaxel + ARPI).
The trial was open-label; the disease-volume analysis is a subgroup analysis (although prespecified), and the comparator, ADT alone, is no longer standard.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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