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Completed

NCT Number: NCT00776594

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Androgen Deprivation Therapy

Drug

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 names: ADT

bicalutamide

Drug

50mg orally daily for 6 months

Bevacizumab

Drug

15mg/ks given IV every three weeks for a total of 8 infusions over 6 months

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
  • Genentech, Inc.
  • Rutgers Cancer Institute of New Jersey

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2016
First posted
Oct 21, 2008
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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