NCT00329043Active, not recruitingPhase 2
Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy
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
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 19 May 2006
- Start date
- 15 May 2006
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT00329043
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 64
- From 15 May 2006 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Patients with small cell or sarcomatoid prostate cancers are not eligible.
- Patients with clinical or radiological evidence of metastatic disease.
- 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.
- 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.
- Overt psychosis, mental disability or otherwise incompetent to give informed consent or history of non-compliance.
Who the study is looking for
- 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.
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.