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New drug combo aims to shrink aggressive prostate tumors before surgery

NCT ID NCT00329043

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

May 2006

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Male participants only

Healthy volunteers

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

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

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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