Clinical trial NCT00776594: Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Official title: Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Androgen deprivation therapy
ADT
bevacizumab
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Rutgers Cancer Institute of New Jersey
First posted: 2008-10-21
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relapse-free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants With PSA <0.2 ng/ml at Six Months
timeFrame: Six months (at completion of treatment)
measure: Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).
timeFrame: 6 months
measure: Analysis of Cytokines and Angiogenic Factors in Plasma/Serum
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Beth-Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: The University of Texas M D Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary-Ellen Taplin, MD
role: PRINCIPAL_INVESTIGATOR
References: