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: January 20, 2014
Last verified: January 2014

October 20, 2008
January 20, 2014
October 2008
June 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00776594 on ClinicalTrials.gov Archive Site
  • Percent of patient PSA <0.2 ng/ml at six months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cardiovascular safety including baseline and post therapy measurement of blood pressure, lipid profiles. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Analysis of cytokines and angiogenic factors in plasma/serum [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

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).

  • 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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2014
June 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00776594
08-190
Yes
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Genentech, Inc.
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Rutgers Cancer Institute of New Jersey
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
January 2014

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