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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

No Placebo-Only Group

Pivotal 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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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