Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy

NCT00329043 | Active Not Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2005-0903NCI-2012-01364
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Adenocarcinoma of the Prostate; Ductal Adenocarcinoma of the Prostate; Hormonal Ablation; Radical Prostatectomy; LHRH Agonist; Lupron; Leuprolide; Sunitinib Malate; SU011248

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Pathological Complete Response (pCR)

  Response defined as pathological complete remission based on operative findings and tissue obtained at surgery.

  Surgery following 3 months of therapy.

Study Arms (1)

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.

Drug: LHRH Agonist; Drug: Sunitinib Malate; Procedure: Radical Prostatectomy

Interventions

LHRH Agonist DRUG

Intramuscular injection either monthly for 3 months or in a single 3-month dose.

Also known as: Lupron, Leuprolide

Sunitinib + Hormonal Ablation Before Prostatectomy

Sunitinib Malate DRUG

25 to 37.5 mg/day once daily for 30 days (= 1 cycle), up to 3 cycles.

Also known as: SU011248

Sunitinib + Hormonal Ablation Before Prostatectomy

Radical Prostatectomy PROCEDURE

Radical prostatectomy after completion of Sunitinib and LHRH agonist.

Sunitinib + Hormonal Ablation Before Prostatectomy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Gonadotropin-Releasing Hormone; Leuprolide; Sunitinib

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Amado Zurita, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2006
• First Posted: May 24, 2006
• Study Start: May 15, 2006
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)