Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01656304
Recruitment Status : Completed
First Posted : August 2, 2012
Results First Posted : July 8, 2014
Last Update Posted : April 20, 2015
Genentech, Inc.
Information provided by (Responsible Party):
Ulka Vaishampayan, Barbara Ann Karmanos Cancer Institute

Brief Summary:
This pilot phase II trial studies how well giving bevacizumab works in treating patients with relapsed prostate cancer that did not respond to hormone therapy. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or tumor-killing substances to them. Bevacizumab may also stop the growth of prostate cancer by blocking blood flow to the tumor

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Biological: bevacizumab Other: laboratory biomarker analysis Phase 2

Detailed Description:


I. The rate of prostate-specific antigen (PSA) response with avastin (bevacizumab) therapy in androgen independent non-metastatic prostate cancer.

II. Toxicities associated with avastin therapy. III. Time to PSA progression.


I. Overall survival of androgen independent non-metastatic prostate cancer patients treated with avastin.

II. The change in PSA velocity with avastin therapy in androgen-independent non-metastatic prostate cancer.

III. Time to distant metastatic disease. IV. Circulating tumor cell count. V. Changes in levels of N terminal collagen peptide and bone-specific alkaline phosphatase with avastin therapy.

VI. Correlation of crosslinked N-telopeptide of type I collagen (NTX) and serum B-Cell-Specific Activator Protein (BSAP) levels with time to PSA progression.


Patients receive bevacizumab intravenously (IV) over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Bevacizumab in PSA Relapse Androgen Independent Prostate Cancer (AVF3952sn)
Study Start Date : May 2007
Actual Primary Completion Date : January 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment (monoclonal antibody, antiangiogenesis)
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer [ Time Frame: An average every 6 weeks for up to 3 months ]
    Response rates will be summarized by point estimates and Wilson type 80% confidence intervals.

  2. Toxicities Associated With Bevacizumab Therapy [ Time Frame: An average of every 2 weeks while on therapy ]
    Toxicity rates will be summarized by point estimates and Wilson type 80% confidence intervals. Toxicities will be graded per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and PSA response will be determined as per PSA Working Group response criteria. Censored time to PSA progression will be estimated with standard Kaplan-Meier methodology.

  3. Time to PSA Progression (TTPP) [ Time Frame: An average every 6 weeks for up to 3 months ]
    TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved. PSA velocity will also be calculated as change in PSA doubling time pre and post therapy and the rate of PSA rise pre- and post-therapy.

Secondary Outcome Measures :
  1. Overall Survival of Androgen Independent Non-metastatic Prostate Cancer Patients Treated With Bevacizumab [ Time Frame: Every 3 months ]
  2. The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer [ Time Frame: Baseline, every 6 weeks while on therapy, and then every 3 months thereafter ]
  3. Time to Distant Metastatic Disease [ Time Frame: Every 3 months ]
  4. Circulating Tumor Cell Count [ Time Frame: Baseline, at week 12 ]
  5. Changes in Levels of N Terminal Collagen Peptide and Bone-specific Alkaline Phosphatase With Bevacizumab Therapy [ Time Frame: Baseline, week 7 or 12, and post-therapy ]
  6. Correlation of Urine NTX and Serum BSAP Levels With Time to PSA Progression [ Time Frame: Baseline, week 7 or 12 and post-therapy ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A histologic diagnosis of prostate adenocarcinoma.
  • No evidence of bone/visceral metastases as visualized on standard imaging such as bone scan, chest X-ray, CT scan or MRI of abdomen and pelvis.
  • PSA-only progression despite androgen deprivation therapy. PSA progression is defined as 3 rising levels, with a minimum interval of 2 weeks between each determination. The last determination must have a minimum value of

    1ng/ml and be determined within two weeks prior to registration. If the second or third confirmatory value is less than the previous value, the patient will still be eligible if a repeat value (No. 4) is found to be greater than all the prior values.

  • If patient has been on antiandrogen in the past 28 days, then PSA progression after withdrawal period (28 days for flutamide and 42 days for bicalutamide or nilutamide) is required.
  • ECOG performance status of 0-1.
  • No prior avastin therapy.
  • No investigational or commercial agents or therapies (except LHRH agonists) may be administered concurrently with the intent to treat the patient's malignancy. Patients on LHRH agonists must continue the use of LHRH agonist therapy. Bisphosphonates can be administered per treating physician discretion.
  • At least 4 weeks must have elapsed since prior systemic therapy, except for LHRH analogue therapy and steroids. If steroids are being used for therapy of prostate cancer, these should be discontinued prior to starting avastin therapy.
  • Age ≥ 18 years.
  • Life expectancy of at least 6 months.
  • Ability to understand and the willingness to sign a written informed consent that is approved by the Institutional Human Investigation Committee.
  • Use of effective means of contraception in subjects.

Exclusion Criteria:

Inability to comply with study and/or follow-up procedures.

  • Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications).
  • Any prior history of hypertensive crisis or hypertensive encephalopathy.
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E).
  • History of myocardial infarction or unstable angina within last 12 months prior to study enrollment.
  • History of stroke or transient ischemic attack within 6 months prior to study enrollment.
  • Known CNS disease.
  • Significant vascular disease (e.g., aortic aneurysm, aortic dissection).
  • Symptomatic peripheral vascular disease.
  • Evidence of bleeding diathesis or coagulopathy.
  • Patients on anticoagulants are allowed if patient has been on therapy for at least 4 weeks and patient has no acute thromboembolic activity.
  • Major surgical procedure, open biopsy, or significant traumatic injury within. 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study.
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Proteinuria at screening as demonstrated by:

    1. Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening

  • Known hypersensitivity to any component of avastin.
  • Refusal to use effective means of contraception.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to avastin.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with immune deficiency such as HIV-positive patients or those receiving combination anti-retroviral therapy are excluded from the study because of lack of safety data for avastin in these patients.

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 identifier (NCT number): NCT01656304

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Genentech, Inc.
Principal Investigator: Ulka Vaishampayan Barbara Ann Karmanos Cancer Institute

Responsible Party: Ulka Vaishampayan, Principal Investigator, Barbara Ann Karmanos Cancer Institute Identifier: NCT01656304     History of Changes
Obsolete Identifiers: NCT00478413
Other Study ID Numbers: 2006-064
NCI-2011-00661 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: August 2, 2012    Key Record Dates
Results First Posted: July 8, 2014
Last Update Posted: April 20, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies, Monoclonal
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors