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

Prostate Cancer Clinical Trial

Official title:

Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00776594
• Other study ID #: 08-190
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 20, 2008
• Last updated: June 2, 2015
• Start date: October 2008
• Est. completion date: December 2015

Study information

• Verified date: June 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Other known NCT identifiers

• NCT01019031

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
• bicalutamide
50mg orally daily for 6 months
• bevacizumab
15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Beth-Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	The University of Texas M D Anderson Cancer Center	Houston	Texas
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Genentech, Inc., Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percent of patient PSA <0.2 ng/ml at six months		2 years	No
Secondary	Cardiovascular safety including baseline and post therapy measurement of blood pressure, lipid profiles.		2 years	Yes
Secondary	Analysis of cytokines and angiogenic factors in plasma/serum		2 years	No