Prostate CancerPhase 2NCT00329043
Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy
A Phase 2 study testing LHRH Agonist, Sunitinib Malate and Radical Prostatectomy in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- LHRH Agonist, Sunitinib Malate and Radical Prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2006to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with histologically confirmed adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included.
- All patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
- All patients must have one of the following high-risk features: clinical (c) T(subscript)3 disease or Gleason 8-10 adenocarcinoma or cT(subscript)2(subscript)b-c and PSA >= 10 ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed.
- ECOG performance status 0 or 1.
- Prior hormonal therapy up to 2 months is permitted.
- Patients must have adequate bone marrow function defined as an absolute peripheral granulocyte count of >= 1,500/mm^3 and platelet count of >= 100,000/mm^3; hemoglobin >= 9.0g/dl; adequate hepatic function defined as a total bilirubin of <=1.5 mg/dl and AST/ALT <= 2 x the upper limit of normal; adequate renal function defined as serum creatinine <= 1.5 x the upper limits of normal or creatinine clearance >= 40cc/min (measured or calculated).
- Patients must sign the current IRB approved informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
- All patients must have a surgical and medical oncology consult prior to signing informed consent.
Who cannot join
- Patients with small cell or sarcomatoid prostate cancers are not eligible.
- Patients with clinical or radiological evidence of metastatic disease.
- Patients receiving ketoconazole as a prior hormonal therapy.
- Prior chemotherapy or experimental agents for prostate cancer.
- Patients with any infection process, in the criterion of the investigator, that could worsen or its outcome be affected, as a result of the investigational therapy.
- Patients with NYHA Class III/IV congestive heart failure, unstable angina, cerebrovascular accident or transient ischemic attack, or pulmonary embolism or myocardial infarction in the last 6 months.
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- Uncontrolled severe hypertension (>= 140/90 despite controlling medication), uncontrolled diabetes mellitus, oxygen-dependent lung disease, known chronic liver disease or HIV infection.
- Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years.
- Ongoing treatment with therapeutic doses of coumadin. However, low dose coumadin up to 2mg PO daily for deep vein thrombosis prophylaxis is allowed. Low molecular weight heparin is allowed.
- Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- LHRH Agonist, Sunitinib Malate, Radical Prostatectomy
- Keywords
- Prostate Cancer, Adenocarcinoma of the Prostate, Ductal Adenocarcinoma of the Prostate, Hormonal Ablation, Radical Prostatectomy, LHRH Agonist, Lupron, Leuprolide, Sunitinib Malate, SU011248
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHRH AgonistDrug
Also called Lupron, Leuprolide
Intramuscular injection either monthly for 3 months or in a single 3-month dose.
Sunitinib MalateDrug
Also called SU011248
25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles.
Radical ProstatectomyProcedure or surgery
Radical prostatectomy after completion of Sunitinib and LHRH agonist.
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib + Hormonal Ablation Before Prostatectomy | Experimental | Sunitinib Malate 25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles. LHRH Agonist intramuscular injection either monthly for 3 months or in a single 3-month dose. Radical prostatectomy after completion of Sunitinib and LHRH agonist. Receives: Drug: LHRH Agonist; Drug: Sunitinib Malate; Procedure: Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pathological Complete Response (pCR)
Response defined as pathological complete remission based on operative findings and tissue obtained at surgery.
Measured: Surgery following 3 months of therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study start15 May 2006
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Amado Zurita, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329043
- Sponsor's protocol ID
- 2005-0903
- Other IDs
- NCI-2012-01364
- Status last verified
- Jun 2026
- First submitted
- 19 May 2006
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00329043
- Acronym / sponsor ID
- 2005-0903
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Adenocarcinoma of the Prostate, Ductal Adenocarcinoma of the Prostate, Hormonal Ablation, Radical Prostatectomy, LHRH Agonist, Lupron, Leuprolide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 15 May 2006 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib + Hormonal Ablation Before Prostatectomy | Experimental | Drug: LHRH Agonist, Drug: Sunitinib Malate, Procedure: Radical ProstatectomySunitinib Malate 25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles. LHRH Agonist intramuscular injection either monthly for 3 months or in a single 3-month dose. Radical prostatectomy after completion of Sunitinib and LHRH agonist. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with histologically confirmed adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included.
- All patients must be regarded as low anesthetic risk for radical prostatectomy and confirm their intention to undergo radical prostatectomy at the end of the neoadjuvant therapy.
- All patients must have one of the following high-risk features: clinical (c) T(subscript)3 disease or Gleason 8-10 adenocarcinoma or cT(subscript)2(subscript)b-c and PSA >= 10 ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed.
- ECOG performance status 0 or 1.
- Prior hormonal therapy up to 2 months is permitted.
Key exclusion criteria (10 listed)
- Patients with small cell or sarcomatoid prostate cancers are not eligible.
- Patients with clinical or radiological evidence of metastatic disease.
- Patients receiving ketoconazole as a prior hormonal therapy.
- Prior chemotherapy or experimental agents for prostate cancer.
- Patients with any infection process, in the criterion of the investigator, that could worsen or its outcome be affected, as a result of the investigational therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LHRH AgonistAlso: Lupron, LeuprolideIntramuscular injection either monthly for 3 months or in a single 3-month dose. | Drug | Sunitinib + Hormonal Ablation Before Prostatectomy |
| Sunitinib MalateAlso: SU01124825 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles. | Drug | Sunitinib + Hormonal Ablation Before Prostatectomy |
| Radical ProstatectomyRadical prostatectomy after completion of Sunitinib and LHRH agonist. | Procedure or surgery | Sunitinib + Hormonal Ablation Before Prostatectomy |
Primary outcome
Number of Participants With Pathological Complete Response (pCR)
Time frame: Surgery following 3 months of therapy.
Response defined as pathological complete remission based on operative findings and tissue obtained at surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amado Zurita, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LHRH Agonist, Sunitinib Malate and Radical Prostatectomy in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Pathological Complete Response (pCR) (time frame: Surgery following 3 months of therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.