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Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
This study is currently recruiting participants.
Study NCT00776594   Information provided by Dana-Farber Cancer Institute
First Received: October 20, 2008   Last Updated: December 16, 2008   History of Changes

October 20, 2008
December 16, 2008
October 2008
September 2010   (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
 
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.
Phase II
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Prostate Cancer
  • Drug: Androgen Deprivation Therapy
  • Drug: bicalutamide
  • Drug: bevacizumab
  • Experimental: Androgen Deprivation Therapy Plus Bevacizumab
  • Experimental: Androgen Deprivation Therapy Alone
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
 
September 2010   (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: Mary-Ellen Taplin, MD 617-632-5092
Contact: Peggy Inman 617-632-4420
United States
 
NCT00776594
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
08-190
Dana-Farber Cancer Institute
  • Genentech
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
December 2008

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