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Radiation Therapy, Androgen Suppression, and Docetaxel in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00528866
First received: September 10, 2007
Last updated: June 2, 2017
Last verified: June 2017
Results First Received: November 23, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: bicalutamide
Drug: docetaxel
Drug: flutamide
Drug: LHRH agonist
Radiation: 3-dimensional conformal radiation therapy
Radiation: radiation therapy

  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
No text entered.

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 Suppression + RT + Docetaxel Luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel

Participant Flow:   Overall Study
    Androgen Suppression + RT + Docetaxel
STARTED   80 
COMPLETED   74 [1] 
NOT COMPLETED   6 
Protocol Violation                6 
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  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.
Eligible and started protocol treatment

Reporting Groups
  Description
Androgen Suppression + RT + Docetaxel LHRH agonist and oral antiandrogen (flutamide or bicalutamide), radiation therapy (RT), and docetaxel

Baseline Measures
   Androgen Suppression + RT + Docetaxel 
Overall Participants Analyzed 
[Units: Participants]
 74 
Age 
[Units: Years]
Median (Full Range)
 62 
 (43 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      74 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Free From Progression at 3 Years   [ Time Frame: From registration to 3 years. ]

2.  Secondary:   Local-regional Progression (3 Year Rate)   [ Time Frame: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.) ]

3.  Secondary:   Distant Metastasis (3-year Rate)   [ Time Frame: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.) ]

4.  Secondary:   Prostate Cancer Death (3-year Rate)   [ Time Frame: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.) ]

5.  Secondary:   Non-prostate Cancer Death (3-year Rate)   [ Time Frame: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.) ]

6.  Secondary:   Overall Survival (3-year Rate)   [ Time Frame: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.) ]

7.  Secondary:   Time to Biochemical (PSA) Failure (3-year Rate)   [ Time Frame: Analysis occurs after all patients have been on study for at least 3 years. (Patients are followed from registration to death or study termination whichever occurs first.) ]

8.  Secondary:   Number of Patients With “Acute” Adverse Events (Based on CTCAE, v3.0)   [ Time Frame: From start of treatment to 90 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed until death or study termination whichever occurs first. ]

9.  Secondary:   Time to “Late” Grade 3+ Adverse Events (Based on CTCAE, v3.0)   [ Time Frame: From 91 to 730 days after the planned end of treatment (21 days after last docetaxel dose). Analysis occurs at the time of the primary analysis. (Patients are followed from registration to death or study termination whichever occurs first.) ]

10.  Secondary:   Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints   [ Time Frame: Analysis can occur at the same time as the primary endpoint if data is available. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00528866     History of Changes
Other Study ID Numbers: RTOG-0621
CDR0000563917
NCI-2009-00740 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: September 10, 2007
Results First Received: November 23, 2016
Last Updated: June 2, 2017