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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Androgen Deprivation Therapy
* Drug: bicalutamide
* Drug: bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Androgen Deprivation Therapy Plus Bevacizumab | Drug: Androgen Deprivation Therapy<br>* 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<br>* Other names: ADT;Drug: bicalutamide<br>* 50mg orally daily for 6 months<br>Drug: bevacizumab<br>* 15mg/ks given IV every three weeks for a total of 8 infusions over 6 months<br>|
| Experimental: Group 2<br>Androgen Deprivation Therapy Alone | Drug: Androgen Deprivation Therapy<br>* 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<br>* Other names: ADT;Drug: bicalutamide<br>* 50mg orally daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free Survival | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With PSA <0.2 ng/ml at Six Months | Number of participants with a PSA <0.2 ng/ml at six months (upon completion of treatment). | Six months (at completion of treatment) | 
| Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months). | The number of patients who developed hypertension (greater that 150 systolic or greater than 90 diastolic) during treatment period. | 6 months | 
| Analysis of Cytokines and Angiogenic Factors in Plasma/Serum | Analysis of cytokines and angiogenic factors in plasma/serum at baseline and at 6 months (end of treatment). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgen deprivation therapy, ADT, bevacizumab