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

September 12, 2016 updated by: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth-Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Cancer Institute Of New Jersey
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M D Anderson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-5669
        • University of Wisconsin Carbone Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Androgen Deprivation Therapy Plus Bevacizumab
Drug: Androgen Deprivation Therapy
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
Other Names:
  • ADT
Drug: bicalutamide
50mg orally daily for 6 months
Drug: bevacizumab
15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
Experimental: Group 2
Androgen Deprivation Therapy Alone
Drug: Androgen Deprivation Therapy
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
Other Names:
  • ADT
Drug: bicalutamide
50mg orally daily for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse-free Survival
Time Frame: 2 years
To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab.
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Beth Israel Deaconess Medical Center
Genentech, Inc.
Brigham and Women's Hospital
Rutgers Cancer Institute of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 20, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (Estimate)

October 21, 2008

Study Record Updates

Last Update Posted (Estimate)

October 21, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-190

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on Androgen Deprivation Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe