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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Androgen Deprivation Therapy
bicalutamide
bevacizumab
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Androgen deprivation therapy, ADT, bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University
  • Beth-Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Karmanos Cancer Institute
  • Cancer Institute of New Jersey
  • Memorial Sloan-Kettering Cancer Center
  • The University of Texas M D Anderson Cancer Center
  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Androgen Deprivation Therapy Plus Bevacizumab

Androgen Deprivation Therapy Alone

Outcomes

Primary Outcome Measures

Relapse-free Survival
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.

Secondary Outcome Measures

Number of Participants With PSA <0.2 ng/ml at Six Months
Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).
Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).
The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.
Analysis of Cytokines and Angiogenic Factors in Plasma/Serum
Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).

Full Information

First Posted
October 20, 2008
Last Updated
September 12, 2016
Sponsor
Dana-Farber Cancer Institute
Collaborators
Genentech, Inc., Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Rutgers Cancer Institute of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00776594
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Genentech, Inc., Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Androgen deprivation therapy, ADT, bevacizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Androgen Deprivation Therapy Plus Bevacizumab
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Androgen Deprivation Therapy Alone
Intervention Type
Drug
Intervention Name(s)
Androgen Deprivation Therapy
Other Intervention Name(s)
ADT
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
bicalutamide
Intervention Description
50mg orally daily for 6 months
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
Primary Outcome Measure Information:
Title
Relapse-free Survival
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants With PSA <0.2 ng/ml at Six Months
Description
Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment).
Time Frame
Six months (at completion of treatment)
Title
Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).
Description
The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period.
Time Frame
6 months
Title
Analysis of Cytokines and Angiogenic Factors in Plasma/Serum
Description
Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment).
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary-Ellen Taplin, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Beth-Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
The University of Texas M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-5669
Country
United States

12. IPD Sharing Statement

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

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