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Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00283062
First received: January 26, 2006
Last updated: January 25, 2012
Last verified: December 2010
History of Changes
Results First Received: December 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostatic Neoplasms
Interventions: Drug: Docetaxel (TAXOTERE®) Chemotherapy
Drug: Leuprolide acetate ( ELIGARD®) Hormonal 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
Originally, the study was planned for 1696 participants to be randomized. However, enrollment was not met and in September 2007, the Steering Committee decided to stop recruitment. Only participants who had signed Informed Consent by then and met eligibility criteria were randomized. 228 participants were randomized to this study.

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
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Leuprolide Acetate - Immediate Treatment (I-HT) Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
Leuprolide Acetate - Deferred Treatment (D-HT) Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.

Participant Flow:   Overall Study
    Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)     Leuprolide Acetate - Immediate Treatment (I-HT)     Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)     Leuprolide Acetate - Deferred Treatment (D-HT)  
STARTED     55     55     56     62  
ADMINISTERED STUDY TREATMENT     50     51     20     17  
COMPLETED HORMONAL THERAPY (6 Cycles)     44     48     15     13  
COMPLETED CHEMOTHERAPY (6 Cycles)     43     0 [1]   15     0 [1]
COMPLETED     43     48     15     13  
NOT COMPLETED     12     7     41     49  
Did not receive any study medication                 5                 4                 36                 45  
Adverse Event                 2                 0                 1                 0  
Lost to Follow-up                 1                 0                 1                 0  
Progressive disease                 0                 0                 1                 0  
Participant did not wish to continue                 3                 2                 1                 0  
Undefined                 0                 1                 1                 4  
chemotherapy not completed (cycle 6)                 1                 0                 0                 0  
[1] Not applicable, since participants in this arm did not receive chemotherapy.



  Baseline Characteristics
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Reporting Groups
  Description
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Leuprolide Acetate - Immediate Treatment (I-HT) Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
Leuprolide Acetate - Deferred Treatment (D-HT) Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
Total Total of all reporting groups

Baseline Measures
    Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)     Leuprolide Acetate - Immediate Treatment (I-HT)     Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)     Leuprolide Acetate - Deferred Treatment (D-HT)     Total  
Number of Participants  
[units: participants]
 		  55     55     56     62     228  
Age  
[units: years]
Mean ± Standard Deviation 		  61.2  ± 7.4     61.6  ± 7.0     62.1  ± 7     62.9  ± 7.5     61.9  ± 7.2  
Age, Customized  
[units: participants]
 		         
<65 years     37     34     35     35     141  
>=65 years     18     21     21     27     87  
Gender  
[units: participants]
 		         
Female     0     0     0     0     0  
Male     55     55     56     62     228  
Race/Ethnicity, Customized  
[units: participants]
 		         
White     48     49     43     59     199  
Black     6     3     7     2     18  
Asian/Oriental     0     1     4     0     5  
Multiracial     0     0     2     0     2  
Other     1     2     0     1     4  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression   [ Time Frame: from the date of surgery up to 3 years after randomization of the last participant ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression
Measure Description

PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of

  • first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks
  • date of the nadir, if PSA nadir did not reach < 0.4 ng/mL (for deferred arm)
  • first radiological/ histological evidence of tumor progression
  • death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression.
Time Frame from the date of surgery up to 3 years after randomization of the last participant  
Safety Issue No  

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.
Intent-to-treat (ITT) population: all randomized participants, regardless of whether or not they received any study drug.

Reporting Groups
  Description
Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Leuprolide Acetate - Immediate Treatment (I-HT) Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
Leuprolide Acetate - Deferred Treatment (D-HT) Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.

Measured Values
    Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)     Leuprolide Acetate - Immediate Treatment (I-HT)     Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)     Leuprolide Acetate - Deferred Treatment (D-HT)  
Number of Participants Analyzed  
[units: participants]
 		  55     55     56     62  
Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression  
[units: participants]
 		  10     14     9     8  

No statistical analysis provided for Progression-free Survival (PFS) Assessment - Number of Participants With Disease Progression



2.  Secondary:   Median Overall Survival (OS)   [ Time Frame: from the date of surgery up to 3 years after randomization of the last participant ]
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3.  Secondary:   Median Cancer-specific Survival (CSS)   [ Time Frame: from the date of surgery up to 3 years after randomization of the last participant ]
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4.  Secondary:   Median Metastasis-free Survival (MFS)   [ Time Frame: from the date of surgery up to 3 years after randomization of the last participant ]
  Show Outcome Measure 4

5.  Secondary:   To Evaluate Quality of Life (QoL) as Measured Using a Functional Assessment of Cancer Therapy-Prostate (FACT-P) Questionnaire   [ Time Frame: from 30 days before randomization (baseline) and 18 months after treatment initiation (for change from baseline) ]
  Show Outcome Measure 5

6.  Secondary:   Assessment of Safety and Tolerability - Number of Participants With Adverse Events (AE)   [ Time Frame: from treatment initiation up to 19 months after treatment initiation ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  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.


Limitations and Caveats
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
The study had difficulties in meeting enrollment goals within a reasonable time frame. The final sample size allowed for the safety analyses but was underpowered for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.  


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-Us@sanofi.com


No publications provided


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00283062     History of Changes
Obsolete Identifiers: NCT00343967
Other Study ID Numbers: XRP6976J_3501, EudraCT # : 2004-002203-32
Study First Received: January 26, 2006
Results First Received: December 16, 2011
Last Updated: January 25, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)