Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-01-02 @ 6:42 AM
Study NCT ID:
NCT01642732
Status:
TERMINATED
Last Update Posted:
2017-05-30
First Post:
2012-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
Study Overview
Official Title:
A Multi-institutional Phase I and Biomarker Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of accrual and funding expires in June, 2014.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are to:
* Determine the safest and highest dose of the study drug RAD001 (Everolimus) that can be taken in combination with hormonal and radiation therapy in men with high risk prostate cancer.
* Evaluate changes in patient reported quality of life
* Evaluate biomarkers from prostate tumor samples. Biomarkers are various traits which can be used to identify the progress of a disease or condition, which can help researchers determine the effect the study treatment has on the tumor. Biomarkers can also help determine areas for further research.
* Determine the safest and highest dose of the study drug RAD001 (Everolimus) that can be taken in combination with hormonal and radiation therapy in men with high risk prostate cancer.
* Evaluate changes in patient reported quality of life
* Evaluate biomarkers from prostate tumor samples. Biomarkers are various traits which can be used to identify the progress of a disease or condition, which can help researchers determine the effect the study treatment has on the tumor. Biomarkers can also help determine areas for further research.
Detailed Description:
Prostate cancer is very prevalent with an estimated \> 200,000 new cases and \> 25,000 deaths attributable to prostate cancer in the United States in 2010. Radiation treatment represents a commonly utilized method to treat prostate cancer with an excellent chance of controlling disease with biochemical control at 5-years in excess of 75% in men with locally confined but intermediate to high-risk disease. However, despite impressive biochemical control, local control remains a problem.
Everolimus is being investigated as an anticancer agent based on its potential to act:
* Directly on the tumor cells by inhibiting tumor cell growth and proliferation
* Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity.
Given the prevalence of PTEN deletion in high-risk prostate cancers as well as the evidence that tumor hypoxia leads to increased risks of failure after treatment with hormonal therapy and radiation, we hypothesis that inhibition of mTOR signaling in both tumor and vascular cells using everolimus concurrent with hormonal and radiation therapy will enhance the efficacy of radiation therapy without an unacceptable risk of toxicity in men with high-risk prostate cancer.
Everolimus has not been approved by the FDA for the treatment of prostate cancer by itself or in combination with radiation and hormonal therapy. It is not known if this combination is safe and effective in prostate cancer. The FDA has allowed their combined use in this clinical trial.
Everolimus is being investigated as an anticancer agent based on its potential to act:
* Directly on the tumor cells by inhibiting tumor cell growth and proliferation
* Indirectly by inhibiting angiogenesis leading to reduced tumor vascularity.
Given the prevalence of PTEN deletion in high-risk prostate cancers as well as the evidence that tumor hypoxia leads to increased risks of failure after treatment with hormonal therapy and radiation, we hypothesis that inhibition of mTOR signaling in both tumor and vascular cells using everolimus concurrent with hormonal and radiation therapy will enhance the efficacy of radiation therapy without an unacceptable risk of toxicity in men with high-risk prostate cancer.
Everolimus has not been approved by the FDA for the treatment of prostate cancer by itself or in combination with radiation and hormonal therapy. It is not known if this combination is safe and effective in prostate cancer. The FDA has allowed their combined use in this clinical trial.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| HUM00047650 | OTHER | Univ Mich Medical School Institutional Review Board (IRBMED) | View |