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Hormone Therapy

Androgen Ablation Therapy + Chemotherapy for Prostate Cancer (CHAARTED Trial)

Phase 3
Waitlist Available
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Awards & highlights

CHAARTED Trial Summary

This trial is studying androgen-ablation therapy and docetaxel to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer.

Who is the study for?
This trial is for men with metastatic prostate cancer who have not been on androgen-deprivation therapy for more than 120 days. They should be in good enough health to participate, as indicated by specific blood counts and organ function tests. Men must agree to use contraception, and they can't join if they've had certain other cancers or heart problems, severe allergies to docetaxel components, or prior hormone therapy in the metastatic setting.Check my eligibility
What is being tested?
The study is testing whether adding chemotherapy (docetaxel) to standard hormone treatment (androgen-ablation therapy) improves outcomes for men with advanced prostate cancer. Participants are randomly assigned to receive either both treatments or just the hormonal therapy alone.See study design
What are the potential side effects?
Possible side effects include allergic reactions to docetaxel, nerve damage (neuropathy), fatigue, digestive issues like nausea and diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, liver function changes, and heart complications.

CHAARTED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Proportion of Patients With PSA Complete Response (CR) at 12 Months
Proportion of Patients With PSA Complete Response (CR) at 6 Months
QOL Change From Baseline to 3 Months
+2 more

CHAARTED Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Androgen-Deprivation Therapy and DocetaxelExperimental Treatment2 Interventions
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Group II: Androgen-Deprivation Therapy aloneActive Control1 Intervention
Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration) alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
docetaxel
2015
Completed Phase 3
~7230

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,952,574 Total Patients Enrolled
565 Trials studying Prostate Cancer
529,064 Patients Enrolled for Prostate Cancer
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,132 Total Patients Enrolled
5 Trials studying Prostate Cancer
1,922 Patients Enrolled for Prostate Cancer
Christopher Sweeney, MBBSStudy ChairDana-Farber Cancer Institute
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Prostate Cancer
27 Patients Enrolled for Prostate Cancer

Media Library

Androgen-deprivation therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00309985 — Phase 3
~42 spots leftby May 2025
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