CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 790 enrolled
Drug / intervention
androgen-deprivation therapy +1 moredrug
Likely dose
Docetaxel IV (specific dose not provided in interventions description)AI-extracted
Key inclusion· 7
  • Histologically or cytologically confirmed prostate cancer
  • Metastatic disease documented
  • On androgen-deprivation therapy for less than 120 days at enrollment
  • ECOG performance status 0–2 (PS 2 only if decline is due to metastatic prostate cancer)
Key exclusion· 9
  • PSA progression since start of androgen-deprivation therapy (rise from nadir meeting progression criteria)
  • Prior malignancy within 5 years except nonmelanoma skin cancer
  • Peripheral neuropathy greater than grade 1
  • History of severe hypersensitivity to docetaxel or polysorbate 80–formulated drugs

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00309985
NCT00309985Phase 3Completed

CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer

ECOG-ACRIN Cancer Research Group·interventional·Posted Apr 3, 2006·Updated Dec 11, 2025

In Brief

A Phase 3 clinical trial evaluating androgen-deprivation therapy and docetaxel for Metastatic Hormone-sensitive Prostate Cancer. Completed, enrolled 790 participants across 343 sites.

Detailed Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen ablation therapy may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer. PURPOSE: This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 3, 2006
Enrollment StartSep 26, 2006
Primary CompletionDec 23, 2013
Study CompletionJan 31, 2025
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.2 years ago

Interventions

androgen-deprivation therapydrug

LHRH analogs are administered with a variety of techniques such as subcutaneously, intramuscularly, or insertion, while antiandrogens (flutamide and bicalutamide) were given orally.

docetaxeldrug

Given IV