Clinical trial · Interventional
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
NCT00776594CI-TRIAL-00024377completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen Deprivation Therapy | Drug | — | UNRESOLVED |
| bevacizumab | Drug | Bevacizumab | ALIAS |
| bicalutamide | Drug | Bicalutamide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Androgen Deprivation Therapy Plus Bevacizumab
- interventionNames
- Drug: Androgen Deprivation Therapy
- Drug: bicalutamide
- Drug: bevacizumab
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Androgen Deprivation Therapy Alone
- interventionNames
- Drug: Androgen Deprivation Therapy
- Drug: bicalutamide
Primary outcomes (1)
- measure
- Relapse-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.