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

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: bicalutamide; Drug: bevacizumab; Drug: Androgen Deprivation Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00776594

08-190

Details and patient eligibility

About

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).

Full 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.

Enrollment: 102 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

Group 1

Experimental group

Description:

Androgen Deprivation Therapy Plus Bevacizumab

Treatment:

Drug: bevacizumab

Drug: Androgen Deprivation Therapy

Drug: bicalutamide

Group 2

Experimental group

Description:

Androgen Deprivation Therapy Alone

Treatment:

Drug: Androgen Deprivation Therapy

Drug: bicalutamide