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

Sponsor:	Dana-Farber Cancer Institute
Collaborators:	Genentech Beth Israel Deaconess Medical Center Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00776594

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bicalutamide Bevacizumab

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To identify a difference in relapse-free survival in men treated with short course ADT (6 months) versus short course ADT plus bevacizumab. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent of patient PSA <0.2 ng/ml at six months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Cardiovascular safety including baseline and post therapy measurement of blood pressure, lipid profiles. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Analysis of cytokines and angiogenic factors in plasma/serum [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	October 2008
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental 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 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
Group 2: Experimental 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 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
Genders 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

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

Contacts

Contact: Mary-Ellen Taplin, MD	617-632-5092
Contact: Yichao Wu	617-582-7334

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Mary-Ellen Taplin, MD
Beth-Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Glenn Bubley, MD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Genentech

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Investigators

Principal Investigator:

Mary-Ellen Taplin, MD

Dana-Farber Cancer Institute

More Information

No publications provided

Responsible Party:	Dana-Farber Cancer Institute ( Mary-Ellen Taplin, MD )
Study ID Numbers:	08-190
Study First Received:	October 20, 2008
Last Updated:	December 7, 2009
ClinicalTrials.gov Identifier:	NCT00776594 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Androgen deprivation therapy
ADT
bevacizumab

Additional relevant MeSH terms:

Bevacizumab
Androgens
Androgen Antagonists
Disease Attributes
Prostatic Diseases
Genital Neoplasms, Male
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Hormones
Pathologic Processes

Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Growth Substances
Genital Diseases, Male
Angiogenesis Inhibitors
Recurrence
Pharmacologic Actions
Neoplasms
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010