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

• ClinicalTrials.gov Identifier: NCT00776594
• Recruitment Status: Completed
• First Posted: October 21, 2008
• Results First Posted: August 23, 2016
• Last Update Posted: October 21, 2016
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Genentech, Inc.; Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Rutgers Cancer Institute of New Jersey
• Information provided by (Responsible Party): Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: October 20, 2008
• First Posted Date: October 21, 2008
• Results First Submitted Date: July 29, 2015
• Results First Posted Date: August 23, 2016
• Last Update Posted Date: October 21, 2016
• Study Start Date: October 2008
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 13, 2016)

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.

• Original Primary Outcome Measures (submitted: October 20, 2008): 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 ]

Current Secondary Outcome Measures (submitted: July 13, 2016)

• 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).
• 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.
• 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).

Original Secondary Outcome Measures (submitted: October 20, 2008)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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).

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

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
  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

Study Arms

• Experimental: Group 1
  Androgen Deprivation Therapy Plus Bevacizumab
  Interventions:

  • Drug: Androgen Deprivation Therapy
  • Drug: bicalutamide
  • Drug: bevacizumab
• Experimental: Group 2
  Androgen Deprivation Therapy Alone
  Interventions:

  • Drug: Androgen Deprivation Therapy
  • Drug: bicalutamide

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 13, 2016): 102
• Original Estimated Enrollment (submitted: October 20, 2008): 100
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00776594
• Other Study ID Numbers: 08-190
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mary-Ellen Taplin, MD, Dana-Farber Cancer Institute
• Study Sponsor: Dana-Farber Cancer Institute

Collaborators

• 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

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: September 2016