← Back to Search

Hormone Therapy

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

Q: What medical conditions are commonly treated with androgen-deprivation therapy?

Malignant neoplasms are most commonly treated with androgen-deprivation therapy. However, this treatment method can also be effective against other conditions, such as <a href="https://www.withpower.com/clinical-trials/sarcoma">sarcoma</a>, esophageal neoplasms, and advance directives.

Q: Has the androgen-deprivation therapy been cleared by the FDA?

There is some data supporting androgen-deprivation therapy's efficacy and multiple rounds of data supporting safety, so the Power team gave it a score of 3.

Q: Is this study active in numerous locations across the United States?

The trial is being conducted at Saint Helena Hospital in <a href="https://www.withpower.com/clinical-trials/california">California</a>, Saint Joseph Mercy <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in <a href="https://www.withpower.com/clinical-trials/michigan">Michigan</a>, and Mercy and Unity Cancer Center at Mercy Hospital in <a href="https://www.withpower.com/clinical-trials/minnesota">Minnesota</a>. There are 100 other locations where the trial is also taking place.

Q: Are new participants still being recruited for this experiment?

According to the latest information on clinicaltrials.gov, this clinical trial is not currently recruiting patients. The trial was originally posted on 7/28/2006 and was last updated on 3/7/2022. Even though this trial is no longer looking for patients, there are 1842 other studies that are.

Q: How many individuals can participate in this clinical trial?

This particular trial is no longer recruiting patients, as the most recent update was on March 7th, 2022. However, there are presently 1507 clinical trials actively searching for patients with hypersensitivity and 335 studies for androgen-deprivation therapy actively searching for participants.

Q: What is the background of androgen-deprivation therapy in terms of clinical research?

As of now, there are 335 androgen-deprivation therapy trials ongoing with 132 in Phase 3. And while a good portion of these androgen-deprivation therapy trials are based in Fuzhou, Fujian, there are 22962 clinical trial locations in total for this research topic.

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 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

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,932,877 Total Patients Enrolled

561 Trials studying Prostate Cancer

507,173 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions are commonly treated with androgen-deprivation therapy?

"Malignant neoplasms are most commonly treated with androgen-deprivation therapy. However, this treatment method can also be effective against other conditions, such as sarcoma, esophageal neoplasms, and advance directives."

Answered by AI

Has the androgen-deprivation therapy been cleared by the FDA?

"There is some data supporting androgen-deprivation therapy's efficacy and multiple rounds of data supporting safety, so the Power team gave it a score of 3."

Answered by AI

Is this study active in numerous locations across the United States?

"The trial is being conducted at Saint Helena Hospital in California, Saint Joseph Mercy Cancer Center in Michigan, and Mercy and Unity Cancer Center at Mercy Hospital in Minnesota. There are 100 other locations where the trial is also taking place."

Answered by AI

Are new participants still being recruited for this experiment?

"According to the latest information on clinicaltrials.gov, this clinical trial is not currently recruiting patients. The trial was originally posted on 7/28/2006 and was last updated on 3/7/2022. Even though this trial is no longer looking for patients, there are 1842 other studies that are."

Answered by AI

How many individuals can participate in this clinical trial?

"This particular trial is no longer recruiting patients, as the most recent update was on March 7th, 2022. However, there are presently 1507 clinical trials actively searching for patients with hypersensitivity and 335 studies for androgen-deprivation therapy actively searching for participants."

Answered by AI

What is the background of androgen-deprivation therapy in terms of clinical research?

"As of now, there are 335 androgen-deprivation therapy trials ongoing with 132 in Phase 3. And while a good portion of these androgen-deprivation therapy trials are based in Fuzhou, Fujian, there are 22962 clinical trial locations in total for this research topic."

Answered by AI

Recent research and studies

Prostate Cancer and Prostatic DiseasesJournal

Surrogate Endpoints for Overall Survival for Patients with Metastatic Hormone-sensitive Prostate Cancer in the CHAARTED Trial

Martini, Alberto, John Pfail, Francesco Montorsi, Matthew D. Galsky, and William K. Oh. 2020. “Surrogate Endpoints for Overall Survival for Patients with Metastatic Hormone-sensitive Prostate Cancer in the CHAARTED Trial”. Prostate Cancer and Prostatic Diseases. Springer Science and Business Media LLC. doi:10.1038/s41391-020-0231-5.

Journal of Clinical OncologyJournal

Seven-month Prostate-specific Antigen Is Prognostic in Metastatic Hormone-sensitive Prostate Cancer Treated with Androgen Deprivation with or Without Docetaxel

Harshman, Lauren C., Yu-Hui Chen, Glenn Liu, Michael A. Carducci, David Jarrard, Robert Dreicer, Noah Hahn, et al.. 2018. “Seven-month Prostate-specific Antigen Is Prognostic in Metastatic Hormone-sensitive Prostate Cancer Treated with Androgen Deprivation with or Without Docetaxel”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2017.75.3921.

New England Journal of MedicineJournal

Chemohormonal Therapy in Metastatic Hormone-sensitive Prostate Cancer

Sweeney, Christopher J., Yu-Hui Chen, Michael Carducci, Glenn Liu, David F. Jarrard, Mario Eisenberger, Yu-Ning Wong, et al.. 2015. “Chemohormonal Therapy in Metastatic Hormone-sensitive Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1503747.

New England Journal of MedicineJournal