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Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

- 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.

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

Exclusion Criteria:

- History of cancer within 5 years, other than prostate cancer and non-melanoma skin

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mary-Ellen Taplin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • Androgen deprivation therapy
  • ADT
  • bevacizumab
  • Prostatic Neoplasms
  • Recurrence



Johns Hopkins UniversityBaltimore, Maryland  21205
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Karmanos Cancer InstituteDetroit, Michigan  48201
The University of Texas M D Anderson Cancer CenterHouston, Texas  77030
Beth-Israel Deaconess Medical CenterBoston, Massachusetts  
University of Wisconsin Carbone Cancer CenterMadison, Wisconsin  53792-5669