Clinical trial · Interventional
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
NCT00329043CI-TRIAL-00114586active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LHRH Agonist | Drug | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
| Sunitinib Malate | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunitinib + Hormonal Ablation Before Prostatectomy
- description
- 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.
- interventionNames
- Drug: LHRH Agonist
- Drug: Sunitinib Malate
- Procedure: Radical Prostatectomy
Primary outcomes (1)
- measure
- Number of Participants With Pathological Complete Response (pCR)
- timeFrame
- Surgery following 3 months of therapy.
- description
- Response defined as pathological complete remission based on operative findings and tissue obtained at surgery.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.