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

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ClinicalTrials.gov Identifier: NCT00776594
Recruitment Status : Completed
First Posted : October 21, 2008
Results First Posted : August 23, 2016
Last Update Posted : October 21, 2016
Sponsor:
Collaborators:
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

Study Description
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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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Androgen Deprivation Therapy Drug: bicalutamide Drug: bevacizumab Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Study Start Date : October 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Bevacizumab

Arms and Interventions
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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 Name: 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 Name: ADT

Drug: bicalutamide
50mg orally daily for 6 months


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776594


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Texas
The University of Texas M D Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792-5669
Sponsors and Collaborators
Dana-Farber Cancer Institute
Genentech, Inc.
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Rutgers Cancer Institute of New Jersey
Investigators
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Principal Investigator: Mary-Ellen Taplin, MD Dana-Farber Cancer Institute
More Information
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Responsible Party: Mary-Ellen Taplin, MD, Associate Professor of Medicine, HMS, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00776594    
Obsolete Identifiers: NCT01019031
Other Study ID Numbers: 08-190
First Posted: October 21, 2008    Key Record Dates
Results First Posted: August 23, 2016
Last Update Posted: October 21, 2016
Last Verified: September 2016
Keywords provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:
Androgen deprivation therapy
ADT
bevacizumab
Additional relevant MeSH terms:
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Prostatic Neoplasms
Recurrence
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Disease Attributes
Pathologic Processes
Bevacizumab
Bicalutamide
Androgens
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones