Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01076335
First received: February 24, 2010
Last updated: June 28, 2016
Last verified: June 2016
Results First Received: June 28, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Neoadjuvant Hormonal 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
Recruitment Period: Enrollment took place from 21 April 2005 to 31 March 2008. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 40 enrolled, one participant (2.5%) declined presurgical therapy after enrollment and was excluded from subsequent analyses.

Reporting Groups
  Description
Neoadjuvant Hormones + Docetaxel One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy

Participant Flow:   Overall Study
    Neoadjuvant Hormones + Docetaxel  
STARTED     40  
COMPLETED     36  
NOT COMPLETED     4  
Withdrawal by Subject                 4  



  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.
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Reporting Groups
  Description
Neoadjuvant Hormones + Docetaxel One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy

Baseline Measures
    Neoadjuvant Hormones + Docetaxel  
Number of Participants  
[units: participants]
  40  
Age  
[units: years]
Median (Full Range)
  61.5  
  (38 to 75)  
Gender  
[units: participants]
 
Female     0  
Male     40  
Region of Enrollment  
[units: participants]
 
United States     40  



  Outcome Measures

1.  Primary:   Number of Participants Progression Free at 1 Year   [ Time Frame: 1 Year ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lance Pagliaro, MD
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 1-877-632-6789
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01076335     History of Changes
Other Study ID Numbers: 2004-0273
P50CA090270 ( US NIH Grant/Contract Award Number )
NCI-2010-01369 ( Registry Identifier: NCI CTRP )
Study First Received: February 24, 2010
Results First Received: June 28, 2016
Last Updated: June 28, 2016
Health Authority: United States: Institutional Review Board
United States: Federal Government