Clinical trial · Interventional
Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer
Phase I/II Study of Sorafenib Concurrent With Androgen Deprivation and Radiotherapy in the Treatment of Intermediate- and High-Risk Localized Prostate Cancer
NCT00924807CI-TRIAL-00036093terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor closed the trial
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprolide acetate, Bicalutamide, Sorafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Androgen Depr, Radiotherapy, Sorafenib
- description
- Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.
- interventionNames
- Drug: Leuprolide acetate, Bicalutamide, Sorafenib
Primary outcomes (1)
- measure
- Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.
- timeFrame
- Day 29 and every 2 weeks
- description
- Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.
Secondary outcomes (1)
- measure
- Biochemical Disease-free Survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed intermediate or high risk prostate adenocarcinoma. Intermediate risk disease comprises T2b/c tumors, Gleason 7 histology, or PSA 10-20. High risk tumors comprise T3-4, Gleason 8 or higher histology, or PSA greater than 20. * Age \> 18 years. * Life expectancy of greater than 5 years. * Patients must have normal organ and marrow function. * No pelvic lymph node metastases based on pelvic CT scan or MRI. * No bone metastasis. A whole body bone scan is required to rule out metastatic disease. Exclusion Criteria: * Any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma. * Patients may not be receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study. * Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C. * Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin will not be allowed to participate.
References
Publications (0)
Data not yet available
No reference posted for this study.