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

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: Androgen Deprivation Therapy Drug: bicalutamide Drug: bevacizumab	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:

Primary Outcome Measures:

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:

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).
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.
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).


Enrollment:	102
Study Start Date:	October 2008
Study Completion Date:	September 2016
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776594

Locations


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


Principal Investigator:	Mary-Ellen Taplin, MD	Dana-Farber Cancer Institute

More Information


Responsible Party:	Mary-Ellen Taplin, MD, Associate Professor of Medicine, HMS, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00776594 History of Changes
Obsolete Identifiers:	NCT01019031
Other Study ID Numbers:	08-190
Study First Received:	October 20, 2008
Results First Received:	July 29, 2015
Last Updated:	September 12, 2016

Keywords provided by Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute:


Androgen deprivation therapy ADT bevacizumab

Additional relevant MeSH terms:


Prostatic Neoplasms Recurrence Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Disease Attributes Pathologic Processes Bevacizumab Bicalutamide Methyltestosterone Ascorbic Acid Androgens	Estrogens, Conjugated (USP) Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Vitamins Micronutrients Estrogens

ClinicalTrials.gov processed this record on July 21, 2017