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

NCT ID: NCT00776594

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2016-09-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Androgen Deprivation Therapy Plus Bevacizumab

Group Type: EXPERIMENTAL

Androgen Deprivation Therapy

Intervention Type: DRUG

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

bicalutamide

Intervention Type: DRUG

50mg orally daily for 6 months

bevacizumab

Intervention Type: DRUG

15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Group 2

Androgen Deprivation Therapy Alone

Group Type: EXPERIMENTAL

Androgen Deprivation Therapy

Intervention Type: DRUG

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

bicalutamide

Intervention Type: DRUG

50mg orally daily for 6 months

Interventions

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

Intervention Type: DRUG

bicalutamide

50mg orally daily for 6 months

Intervention Type: DRUG

bevacizumab

15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Intervention Type: DRUG

Other Intervention Names

ADT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Rutgers Cancer Institute of New Jersey

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Mary-Ellen Taplin, MD

Associate Professor of Medicine, HMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary-Ellen Taplin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

The University of Texas M D Anderson Cancer Center

Houston, Texas, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

08-190

Identifier Type: -

Identifier Source: org_study_id

NCT01019031

Identifier Type: -

Identifier Source: nct_alias