Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329043
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2006-05-19
Brief Title:
Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Neoadjuvant Trial of Sunitinib Malate SU011248 Plus Hormonal Ablation for Patients Who Have High Risk Localized Prostate Cancer and Will Undergo Prostatectomy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn if the addition of sunitinib malate SU011248 to hormone based castration is an effective treatment for shrinking or controlling the tumor before having the prostate removed
Detailed Description:
Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer Hormonal treatment is used to lower testosterone levels in the body because prostate cancer cells need testosterone to survive
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study Your complete medical history will be recorded You will have a physical exam including measurement of vital signs blood pressure pulse temperature and weight Blood about 2 teaspoons and urine will be collected for routine tests You will have a computerized tomography CT or magnetic resonance imaging MRI scan a bone scan or a chest x-ray to evaluate the status of your disease You will be asked about any medications or treatments you are currently taking You will have an electrocardiogram ECG - a test that measures the electrical activity of the heart and an echocardiogram An echocardiogram uses sound waves to make pictures of your heart which helps show how well your heart pumps blood You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size Your ability to perform daily activities will also be evaluated You will have a bone marrow aspirate and biopsy To collect a bone marrow aspirate and biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle
If you are found to be eligible to take part in this study you will take the sunitinib malate by mouth 1 time a day for 30 days together with hormonal ablation therapy You will receive hormone injections to lower the levels of testosterone in the blood Hormonal therapy may be given either monthly for 3 months or in a single 3-month dose Every 30 days is considered a study cycle You may receive up to 3 cycles of treatment
On Day 1 of each cycle you will have a physical exam and you will be asked about your medical history Blood about 2 teaspoons will be drawn for routine tests You will be asked about any medications you have taken and any side effects you may have experienced You will be asked questions about your ability to perform daily activities performance status evaluation
On Day 15 of Cycle 1 you will be asked about any side effects you have experienced Blood about 2 teaspoons will be drawn for routine testing
After completing 3 cycles of treatment you will have surgery to remove your prostate The surgery will occur 1-2 weeks after you receive the last dose of study drug
After the last dose of the study drug you will have a follow-up visit You will be asked about any side effects you are experiencing and you will have a physical exam You will also have digital rectal exam Blood about 2 teaspoons will be drawn for routine tests You will also have an echocardiogram An echocardiogram uses sound waves to make pictures of your heart which helps show how well your heart pumps blood You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size
You will have a follow-up visit 28 days after you stop treatment You will have a physical exam and your complete medical history will be recorded Blood about 2 teaspoons will be drawn for routine tests You will be asked about any medications you have taken and any side effects you may have experienced You will have a performance status evaluation You will have an echocardiogram if it was abnormal at your last visit
About 3 months after your surgery you will return for another follow-up visit You will have a physical exam and your complete medical history will be recorded Blood about 2 teaspoons will be drawn for routine tests You will have a performance status evaluation
For the first year after surgery you will have a prostate specific antigen PSA blood test every 3 months Two 2 years after surgery you will begin having PSA tests every 6 months
This is an investigational study Sunitinib malate has been authorized by the FDA for research purposes only About 64 patients will take part in this study All will be enrolled at M D Anderson
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study Your complete medical history will be recorded You will have a physical exam including measurement of vital signs blood pressure pulse temperature and weight Blood about 2 teaspoons and urine will be collected for routine tests You will have a computerized tomography CT or magnetic resonance imaging MRI scan a bone scan or a chest x-ray to evaluate the status of your disease You will be asked about any medications or treatments you are currently taking You will have an electrocardiogram ECG - a test that measures the electrical activity of the heart and an echocardiogram An echocardiogram uses sound waves to make pictures of your heart which helps show how well your heart pumps blood You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size Your ability to perform daily activities will also be evaluated You will have a bone marrow aspirate and biopsy To collect a bone marrow aspirate and biopsy an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle
If you are found to be eligible to take part in this study you will take the sunitinib malate by mouth 1 time a day for 30 days together with hormonal ablation therapy You will receive hormone injections to lower the levels of testosterone in the blood Hormonal therapy may be given either monthly for 3 months or in a single 3-month dose Every 30 days is considered a study cycle You may receive up to 3 cycles of treatment
On Day 1 of each cycle you will have a physical exam and you will be asked about your medical history Blood about 2 teaspoons will be drawn for routine tests You will be asked about any medications you have taken and any side effects you may have experienced You will be asked questions about your ability to perform daily activities performance status evaluation
On Day 15 of Cycle 1 you will be asked about any side effects you have experienced Blood about 2 teaspoons will be drawn for routine testing
After completing 3 cycles of treatment you will have surgery to remove your prostate The surgery will occur 1-2 weeks after you receive the last dose of study drug
After the last dose of the study drug you will have a follow-up visit You will be asked about any side effects you are experiencing and you will have a physical exam You will also have digital rectal exam Blood about 2 teaspoons will be drawn for routine tests You will also have an echocardiogram An echocardiogram uses sound waves to make pictures of your heart which helps show how well your heart pumps blood You will be asked to lie on your left side while a technician places a probe with gel on your chest to create images of your heart to determine the function and size
You will have a follow-up visit 28 days after you stop treatment You will have a physical exam and your complete medical history will be recorded Blood about 2 teaspoons will be drawn for routine tests You will be asked about any medications you have taken and any side effects you may have experienced You will have a performance status evaluation You will have an echocardiogram if it was abnormal at your last visit
About 3 months after your surgery you will return for another follow-up visit You will have a physical exam and your complete medical history will be recorded Blood about 2 teaspoons will be drawn for routine tests You will have a performance status evaluation
For the first year after surgery you will have a prostate specific antigen PSA blood test every 3 months Two 2 years after surgery you will begin having PSA tests every 6 months
This is an investigational study Sunitinib malate has been authorized by the FDA for research purposes only About 64 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01364 | REGISTRY | NCI CTRP | None |