Phase 2
Completed N=102
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Source: ClinicalTrials.gov NCT00776594 ↗Enrolled (actual)
102
Serious AEs
22.6%
Results posted
Aug 2016
Primary outcomePrimary: Relapse-free Survival — 13; 10 months
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse-free Survival |
13; 10 | — |
| SECONDARY Number of Participants With PSA <0.2 ng/ml at Six Months |
51; 27 | — |
| SECONDARY Cardiovascular Safety Including Measurement of Blood Pressure During Treatment Period (6 Months). |
48; 13 | — |
| SECONDARY Analysis of Cytokines and Angiogenic Factors in Plasma/Serum |
13755; 10179 | — |
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 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 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
Data sourced from ClinicalTrials.gov (NCT00776594). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.