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NCT01120236 · ClinicalTrials.gov registry record · Phase 2
Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 211
- Enrollment target
NCT01120236: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01120236 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 211 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01120236, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 211 participants
- Enrollment target
Study Summary
This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to see how well they work when given with or without cixutumumab in treating patients with newly diagnosed metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, goserelin, or leuprolide acetate, may lessen the amount of androgens made by the body. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether bicalutamide, goserelin, or leuprolide acetate are more effective when given with or without cixutumumab in treating prostate cancer.
Primary Outcome
Undetectable PSA rate (\<= 0.2 ng/mL) after seven cycles (28 weeks) of protocol treatment
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Bicalutamide
- DRUG Goserelin Acetate
- DRUG Leuprolide Acetate
- BIOLOGICAL Cixutumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2010-12 |
| Est. Completion | 2017-08-23 |
| Phase | Phase 2 |
What the finished NCT01120236 record still lists
NCT01120236 is an interventional study that assigns participants to a tested intervention. The registered 211 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% higher).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01120236 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01120236 about?
NCT01120236 is a clinical study titled "Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer". This randomized phase II trial is studying bicalutamide, goserelin, or leuprolide acetate to see how well they work when given with or without cixutumumab in treating patients with newly diagnosed metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Antihormone therap...
What is the current status of trial NCT01120236?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 211 participants. The study started on 2010-12. Estimated completion is 2017-08-23.
What interventions are being tested in trial NCT01120236?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Bicalutamide (DRUG), Goserelin Acetate (DRUG), Leuprolide Acetate (DRUG), Cixutumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01120236?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01120236's enrollment target sits among peer trials
211 290th of 2000 higher than 1,711 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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