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



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/27/2013
Start Date:October 2008
End Date:June 2013
Contact:Mary-Ellen Taplin, MD
Phone:617-632-5092

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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


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.

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
We found this trial at
8
sites
4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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from
Boston, MA
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1275 York Avenue
New York, New York 10065
212-639-2000
Memorial Sloan-Kettering Cancer Center Memorial Sloan-Kettering Cancer Center — the world's oldest and largest private...
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from
New York, NY
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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from
Boston, MA
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from
Houston, TX
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600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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Madison, WI
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195 Little Albany St
New Brunswick, New Jersey 08903
(732) 235-2465
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School As New...
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from
New Brunswick, NJ
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