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

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ClinicalTrials.gov Identifier: NCT00776594
Recruitment Status : Completed
First Posted : October 21, 2008
Results First Posted : August 23, 2016
Last Update Posted : October 21, 2016
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

Tracking Information
First Submitted Date  ICMJE October 20, 2008
First Posted Date  ICMJE October 21, 2008
Results First Submitted Date  ICMJE July 29, 2015
Results First Posted Date  ICMJE August 23, 2016
Last Update Posted Date October 21, 2016
Study Start Date  ICMJE October 2008
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
Relapse-free Survival [ Time Frame: 2 years ]
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab. [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • Number of Participants With PSA <0.2 ng/ml at Six Months [ Time Frame: Six months (at completion of treatment) ]
    Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).
  • Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months). [ Time Frame: 6 months ]
    The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.
  • Analysis of Cytokines and Angiogenic Factors in Plasma/Serum [ Time Frame: 6 months ]
    Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
  • Percent of patient PSA <0.2 ng/ml at six months [ Time Frame: 2 years ]
  • Cardiovascular safety including baseline and post therapy measurement of blood pressure, lipid profiles. [ Time Frame: 2 years ]
  • Analysis of Cytokines and Angiogenic Factors in Plasma/Serum [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Official Title  ICMJE Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Brief Summary The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).
Detailed Description
  • Participants will be randomized into one of two study groups. The first group will receive Androgen Deprivation Therapy (ADT) plus bevacizumab. The second group will receive ADT alone.
  • For the Androgen Deprivation therapy either (treating physician discretion)leuprolide or goserelin acetate (given as injections) every 3 months for a total of 6 months. Bicalutamide will also be taken orally daily for a total of 6 months.
  • Bevacizumab will be given intravenously every three weeks for a total of 8 infusions over 6 months.
  • Participants will be evaluated every 7-9 weeks with vitals, physical exam, PS, laboratories including PSA and testosterone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: 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
    Other Name: ADT
  • Drug: bicalutamide
    50mg orally daily for 6 months
  • Drug: bevacizumab
    15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
Study Arms  ICMJE
  • Experimental: Group 1
    Androgen Deprivation Therapy Plus Bevacizumab
    Interventions:
    • Drug: Androgen Deprivation Therapy
    • Drug: bicalutamide
    • Drug: bevacizumab
  • Experimental: Group 2
    Androgen Deprivation Therapy Alone
    Interventions:
    • Drug: Androgen Deprivation Therapy
    • Drug: bicalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 13, 2016)
102
Original Estimated Enrollment  ICMJE
 (submitted: October 20, 2008)
100
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • History of biopsy documented prostate cancer (any Gleason score)
  • Past treatment with prostatectomy with or without salvage prostate/pelvic radiation or primary radiation (external beam or brachytherapy)
  • If past prostatectomy, pathologic stage no greater than T1-3, N1, M0
  • PSA recurrence with PSAdt < 18 months. There is no minimum PSA for prostatectomy patients. For patients treated with primary radiation therapy PSA should be greater than 2.0 ng/ml
  • No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis or CXR
  • Prior ADT allowed if < 6 months and testosterone recovered to within 50 units (ng/dl) of normal range
  • ECOG Performance status of 0-1
  • Absolute neutrophil count of >1,500
  • Platelet count > 100,000
  • Hg > 8g/dl
  • No history of bleeding or thromboses within the last 12 months that required medical intervention

Exclusion Criteria:

  • History of cancer within 5 years, other than prostate cancer and non-melanoma skin cancer
  • Medical condition requiring concomitant corticosteroids
  • Active infection
  • Prior chemotherapy allowed if was < 6 cycles and > 6 months prior to study entry
  • Documented local recurrence or metastatic prostate cancer
  • Inability to comply with study and/or follow-up procedures
  • Life expectancy of less than 2 years
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776594
Other Study ID Numbers  ICMJE 08-190
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Genentech, Inc.
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Rutgers Cancer Institute of New Jersey
Investigators  ICMJE
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP