Clinical trial · Interventional
Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer
Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer
NCT00349557CI-TRIAL-00015102completedPhase 2ClinicalTrials.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 study is to determine the acute and late toxicities from radiation therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks for 12 weeks), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2 years).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab, bicalutamide and goserelin | Drug | — | UNRESOLVED |
| intensity modulated radiation therapy (IMRT) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the acute (within 90 days from 1st day of radiation therapy) toxicities from intensity modulated radiation therapy (IMRT) in conjunction with bevacizumab, bicalutamide, and goserelin.
Secondary outcomes (2)
- measure
- To evaluate the late toxicities (>90 days from 1st day of radiation therapy) of IMRT, bevacizumab, bicalutamide, and goserelin. Patients will be followed on study for toxicity evaluation for at least one year from day 1 if radiation therapy.
- measure
- To determine the tolerability of the combination of bevacizumab and hormonal therapy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * High Risk Prostate Cancer as defined as ONE of the following: 1. Clinical T2b-T4 2. Gleason sum score 8-10 3. PSA more than 20 and Gleason sum score 7 4. In addition, clinical T2a patients are eligible if 5 or more biopsies contain Gleason 4+3 cancer (minimum of 10 biopsies total required) * No evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis * ECOG performance status of 0, 1 or 2 Exclusion Criteria: * Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer; any major surgery within four weeks, prior hormonal therapy (except finasteride for obstructive voiding symptoms) * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study; Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0 * Presence of central nervous system or brain metastases * Blood pressure of \>150/100 mmHg * History of myocardial infarction within 6 months * History of stroke within 6 months * 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.