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

NCT00776594 | Completed Phase 2 Results DMC

• 1 other identifier: 08-190
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 8

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).

Conditions

Prostate Cancer

Keywords

Androgen deprivation therapy; ADT; bevacizumab

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• Number of Participants With PSA <0.2 ng/ml at Six Months

  Six months (at completion of treatment)

• Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months).

  6 months

• Analysis of Cytokines and Angiogenic Factors in Plasma/Serum

  6 months

Study Arms (2)

Group 1

EXPERIMENTAL

Androgen Deprivation Therapy Plus Bevacizumab

Drug: Androgen Deprivation Therapy; Drug: bicalutamide; Drug: bevacizumab

Group 2

EXPERIMENTAL

Androgen Deprivation Therapy Alone

Drug: Androgen Deprivation Therapy; Drug: bicalutamide

Interventions

Androgen Deprivation Therapy 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

Also known as: ADT

Group 1; Group 2

bicalutamide DRUG

50mg orally daily for 6 months

Group 1; Group 2

bevacizumab DRUG

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Genentech, Inc.: collaborator
• Beth Israel Deaconess Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (8)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

The University of Texas M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792-5669, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Androgen Antagonists; bicalutamide; Bevacizumab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Mary-Ellen Taplin, MD
• Organization: Dana Farber Cancer Institute

Mary_taplin@dfci.harvard.edu

617-632-6328

Study Officials

• Mary-Ellen Taplin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, HMS

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: October 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: September 1, 2016
• Last Updated: October 21, 2016
• Results First Posted: August 23, 2016

Record last verified: 2016-09

Locations

US (8)