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Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer (CHAARTED)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier:
NCT00309985
First received: March 29, 2006
Last updated: February 1, 2016
Last verified: February 2016
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Hormone-sensitive Prostate Cancer
Interventions: Drug: androgen-deprivation therapy
Drug: docetaxel

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was activated on July 28, 2006 and closed to accrual on November 21, 2012, after accrual of 790 patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Androgen-Deprivation Therapy and Docetaxel 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.
Androgen-Deprivation Therapy Alone Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).

Participant Flow:   Overall Study
    Androgen-Deprivation Therapy and Docetaxel     Androgen-Deprivation Therapy Alone  
STARTED     397     393  
Toxicity Analysis     390     392  
Both Baseline and 3-month FACT-P Evals     334     299  
COMPLETED     335     392 [1]
NOT COMPLETED     62     1  
Disease progression                 12                 0  
Adverse Event                 30                 0  
Death                 2                 0  
Withdrawal by Subject                 5                 1  
Physician Decision                 3                 0  
Never started treatment                 7                 0  
Complicating disease                 1                 0  
Non-compliance                 1                 0  
Chemotherapy discontinued only                 1                 0  
[1] Arm B tx info was not collected so only 1 patient w/o follow-up data was considered "not completed".



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized patients

Reporting Groups
  Description
Androgen-Deprivation Therapy and Docetaxel 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.
Androgen-Deprivation Therapy Alone Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
Total Total of all reporting groups

Baseline Measures
    Androgen-Deprivation Therapy and Docetaxel     Androgen-Deprivation Therapy Alone     Total  
Number of Participants  
[units: participants]
  397     393     790  
Age  
[units: years]
Median (Full Range)
  64  
  (36 to 88)  
  63  
  (39 to 91)  
  63  
  (36 to 91)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     397     393     790  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: 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 ]

2.  Secondary:   Time to Clinical Progression   [ Time Frame: 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 ]

3.  Secondary:   Time to Castration Resistant Prostate Cancer (Hormone Refractory Disease)   [ Time Frame: 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 ]

4.  Secondary:   Proportion of Patients With PSA Complete Response (CR) at 6 Months   [ Time Frame: Assessed at 6 months ]

5.  Secondary:   Proportion of Patients With PSA Complete Response (CR) at 12 Months   [ Time Frame: Assessed at 12 months ]

6.  Secondary:   QOL Change From Baseline to 3 Months   [ Time Frame: Assessed at baseline and 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012


Publications of Results:

Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier: NCT00309985     History of Changes
Other Study ID Numbers: E3805
E3805 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA180794 ( US NIH Grant/Contract Award Number )
Study First Received: March 29, 2006
Results First Received: December 17, 2015
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration