New drug combo aims to shrink aggressive prostate tumors before surgery
NCT ID NCT00329043
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether adding the drug sunitinib to standard hormone therapy can shrink or control high-risk prostate cancer before the prostate is removed. About 64 men with localized but aggressive prostate cancer will receive sunitinib pills plus a hormone blocker for up to 3 months, then undergo surgery. The main goal is to see if the cancer completely disappears in the removed tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sunitinib malate (Sutent) plus a hormone blocker (LHRH agonist like Lupron)
- What this could lead to
- If it works, this combination could help shrink aggressive prostate tumors before surgery, potentially lowering the risk of cancer coming back.
- What could go wrong
- This is a small, early-phase trial (64 people) with no control group, so results may not apply broadly. Sunitinib can cause side effects like fatigue, high blood pressure, and liver issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2006
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with histologically confirmed adenocarcinoma of the prostate that in the opinion of the surgeon is resectable. Ductal adenocarcinoma of the prostate is included. 2. 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. 3. 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. 4. ECOG performance status 0 or 1. 5. Prior hormonal therapy up to 2 months is permitted. 6. 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). 7. 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. 8. All patients must have a surgical and medical oncology consult prior to signing informed consent. Exclusion Criteria: 1. Patients with small cell or sarcomatoid prostate cancers are not eligible. 2. Patients with clinical or radiological evidence of metastatic disease. 3. Patients receiving ketoconazole as a prior hormonal therapy. 4. Prior chemotherapy or experimental agents for prostate cancer. 5. 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. 6. 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. 7. Uncontrolled severe hypertension (\>= 140/90 despite controlling medication), uncontrolled diabetes mellitus, oxygen-dependent lung disease, known chronic liver disease or HIV infection. 8. Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3 years. 9. 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. 10. Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
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- Can a 10-Hour eating window fight cancer fatigue?