Clinical trial · Interventional
Study of Effectiveness of IMC-A12 Antibody Combined With Hormone Therapy Prior to Surgery to Treat Prostate Cancer
Phase II Study of Neoadjuvant IMC-A12 Combined With Androgen Deprivation Prior to Prostatectomy
NCT00769795CI-TRIAL-00026678completedPhase 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 whether combination treatment of prostate cancer with IMC-A12 (an antibody which blocks insulin-like growth factor receptor activity) with hormonal therapy (testosterone lowering) before prostatectomy, will be more effective than prior results with hormonal therapy alone.
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 |
|---|---|---|---|
| Bicalutamide | Drug | Bicalutamide | ALIAS |
| Goserelin | Drug | Goserelin | ALIAS |
| IMC-A12 | Drug | Cixutumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Bicalutamide 50 mg daily for 12 weeks Goserelin 10.8 mg SC once IMC-A12 10 mg/kg IV every three weeks for 12 weeks
- interventionNames
- Drug: IMC-A12
- Drug: Bicalutamide
- Drug: Goserelin
Primary outcomes (1)
- measure
- The primary endpoint of the study is to determine the effects of combining androgen deprivation with IMC-A12 on pathologic tumor stage (pathologic complete response).
- timeFrame
- At the time of prostatectomy after 3 months of treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men 18 years or older with clinically localized prostate cancer who have chosen surgery (prostatectomy) and are at high risk of cancer relapse due to clinical stage, Gleason Score, PSA level, or a combination of the three. * Good health and laboratory values within reasonable limits Exclusion Criteria: * Patients with prostate cancer that has spread outside the prostate. * Patients who have low testosterone * Patients who have received hormonal therapies or drugs which affect hormone metabolism * Patients with serious medical conditions such as diabetes, other cancers, stroke, cardiovascular disease. * Patients who are receiving other investigational therapy or chemotherapy. * Patients who are unwilling to use contraceptives during and for a short time after the study * Inability to give informed consent for any reason
References
Publications (1)
- DERIVEDDean JP, Sprenger CC, Wan J, Haugk K, Ellis WJ, Lin DW, Corman JM, Dalkin BL, Mostaghel E, Nelson PS, Cohen P, Montgomery B, Plymate SR. Response of the insulin-like growth factor (IGF) system to IGF-IR inhibition and androgen deprivation in a neoadjuvant prostate cancer trial: effects of obesity and androgen deprivation. J Clin Endocrinol Metab. 2013 May;98(5):E820-8. doi: 10.1210/jc.2012-3856. Epub 2013 Mar 26. PMID 23533230