Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments androgen deprivation therapy, bicalutamide, bevacizumab
Phase phase 2
Target VEGF
Sponsor Dana-Farber Cancer Institute
Collaborator Genentech, Inc.
Start date October 2008
End date December 2014
Trial size 100 participants
Trial identifier NCT00776594, 08-190, NCT01019031

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Androgen Deprivation Therapy Plus Bevacizumab
androgen deprivation therapy ADT
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
50mg orally daily for 6 months
bevacizumab
15mg/ks given IV every three weeks for a total of 8 infusions over 6 months
(Experimental)
Androgen Deprivation Therapy Alone
androgen deprivation therapy ADT
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
50mg orally daily for 6 months

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Percent of patient PSA <0.2 ng/ml at six months
time frame: 2 years
Cardiovascular safety including baseline and post therapy measurement of blood pressure, lipid profiles.
time frame: 2 years
Analysis of cytokines and angiogenic factors in plasma/serum
time frame: 2 years

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Principal investigator Mary-Ellen Taplin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.