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

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

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).

- 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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group 1
  • Androgen Deprivation Therapy Plus Bevacizumab
• Experimental: Group 2
  • Androgen Deprivation Therapy Alone

Primary 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
    Safety Issue?: No

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Dana-Farber Cancer Institute Other

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Mary-Ellen Taplin, MD 617-632-5092 

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00776594

Study ID Number: 08-190

ClinicalTrials.gov Identifier: NCT00776594

Health Authority: United States: Institutional Review Board