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

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

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, 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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	October 21, 2008
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:

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