A Study of Ixabepilone Before Surgery for High-Risk Localized Prostate Cancer
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Official title
A Phase II Study of Ixabepilone Prior to Surgery for High-risk Localized Prostate Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery. Prostate cancer is a common and important health issue facing men in the United States. Most patients with prostate cancer are identified when the disease is limited to the prostate gland itself (localized prostate cancer). A standard treatment for some patients with localized prostate cancer is removal of the prostate gland in an operation known as a "radical prostatectomy." A sub-set of patients with localized prostate cancer can be identified who are at high-risk of suffering a recurrence of prostate cancer after radical prostatectomy. For these patients, additional treatments are being investigated to combine with surgery in the hopes of increasing the chances for cure. Several kinds of chemotherapy medicines have been used for advanced prostate cancer which returns after initial therapy. Epothilones are a newly developed class of chemotherapy drugs that appear promising for the treatment of many forms of cancer. Ixabepilone is drug in the epothilone class of chemotherapy medicines that has shown encouraging results for the treatment of advanced prostate cancer and other cancers in clinical trials. This trial will include men with high-risk localized prostate cancer who will receive treatment with ixabepilone (4 cycles over 12 weeks) prior to radical prostatectomy. The goal of this trial will be to determine if analysis of genes and proteins in prostate cancer tissue taken before and after treatment can be used to predict ixabepilone response. In addition, this trial will evaluate the safety and feasibility of administering ixabepilone prior to radical prostatectomy for patients at high-risk of developing recurrent prostate cancer. The study has three phases: Screening, Treatment and Follow-up * Screening: Eligibility will be verified * Treatment: Subjects will receive Ixabepilone, which will be administered every 21 days for 4 cycles prior to surgery * Follow up: Subjects will be followed every 6 months for up to 5 years. In addition, tissue will be collected at the time of surgery for genetic and protein studies. Blood will also be collected pre and post therapy for proteomic and/or genetic studies.
Study identification
- NCT ID
- NCT00672009
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 11 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2008 (Type not available)
- Primary completion
- Apr 2011 (Actual)
- Completion
- Aug 2012 (Actual)
- Last update posted
- Oct 24, 2018
2008 – 2012
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00672009, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 24, 2018 · Synced Nov 15, 2026
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