Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00776594
First received: October 20, 2008
Last updated: July 13, 2016
Last verified: July 2016
Results First Received: July 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Androgen Deprivation Therapy
Drug: bicalutamide
Drug: bevacizumab

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months


Participant Flow:   Overall Study
    Androgen Deprivation Therapy Plus Bevacizumab     Androgen Deprivation Therapy Alone  
STARTED     66     36  
COMPLETED     62     34  
NOT COMPLETED     4     2  



  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
Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

bevacizumab: 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy Alone

Androgen Deprivation Therapy: leuprolide: 22.5mg given IM every 3 months for a total of 6 months or, goserelin acetate: 10.8mg given SC every 3 months for a total of 6 months

bicalutamide: 50mg orally daily for 6 months

Total Total of all reporting groups

Baseline Measures
    Androgen Deprivation Therapy Plus Bevacizumab     Androgen Deprivation Therapy Alone     Total  
Number of Participants  
[units: participants]
  66     36     102  
Age  
[units: years]
Median (Inter-Quartile Range)
  66  
  (60 to 69)  
  63  
  (60 to 68)  
  65  
  (65 to 69)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     66     36     102  



  Outcome Measures
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1.  Primary:   Relapse-free Survival   [ Time Frame: 2 years ]

2.  Secondary:   Number of Participants With PSA <0.2 ng/ml at Six Months   [ Time Frame: Six months (at completion of treatment) ]

3.  Secondary:   Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).   [ Time Frame: 6 months ]

4.  Secondary:   Analysis of Cytokines and Angiogenic Factors in Plasma/Serum   [ Time Frame: 6 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
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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 NOT 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.


Results Point of Contact:  
Name/Title: Mary-Ellen Taplin, MD
Organization: Dana Farber Cancer Institute
phone: 617-632-6328
e-mail: Mary_taplin@dfci.harvard.edu



Responsible Party: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00776594     History of Changes
Obsolete Identifiers: NCT01019031
Other Study ID Numbers: 08-190
Study First Received: October 20, 2008
Results First Received: July 29, 2015
Last Updated: July 13, 2016
Health Authority: United States: Institutional Review Board