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Hormone Therapy

Sunitinib + Hormone Therapy for Prostate Cancer

Phase 2

Waitlist Available

Led By Amado Zurita, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

All patients must have one of the following high-risk features: clinical (c) T3 disease or Gleason 8-10 adenocarcinoma or cT2b-c and PSA >= 10 ng/ml and Gleason 7 adenocarcinoma. The 1992 AJCC staging system will be followed.

Must not have

Patients with small cell or sarcomatoid prostate cancers are not eligible.

Patients receiving ketoconazole as a prior hormonal therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surgery following 3 months of therapy.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding sunitinib to hormone therapy can better shrink or control the tumor before surgery.

Who is the study for?

This trial is for men with confirmed adenocarcinoma of the prostate that's considered removable by surgery. They must be at low risk for anesthesia during prostate removal, intend to have this surgery after therapy, and meet specific cancer severity criteria (like Gleason score 8-10). Participants need normal organ function and can't have had certain treatments or conditions like metastatic disease, recent heart issues, uncontrolled hypertension or diabetes.

What is being tested?

The study tests if adding Sunitinib Malate to hormone-based castration before removing the prostate helps shrink/control the tumor. It involves a drug called Sunitinib Malate combined with hormonal therapy prior to radical prostatectomy—a surgical procedure to remove the prostate gland.

What are the potential side effects?

Sunitinib Malate may cause side effects such as fatigue, diarrhea, skin discoloration, mouth sores, high blood pressure, bleeding events and potentially affect liver enzymes. Hormonal ablation can lead to hot flashes, reduced sexual desire and other hormone-related changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is advanced or very aggressive based on its size, PSA levels, and Gleason score.

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I am considered low risk for anesthesia and plan to have surgery to remove my prostate after initial treatment.

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I can carry out all my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer is not small cell or sarcomatoid type.

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I have been treated with ketoconazole for hormone therapy.

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I have not had severe heart failure, unstable chest pain, stroke, or major heart events in the last 6 months.

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I do not have severe high blood pressure, uncontrolled diabetes, lung disease requiring oxygen, chronic liver disease, or HIV.

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I have received chemotherapy or experimental treatments for prostate cancer.

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I am mentally capable and willing to follow study requirements.

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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surgery following 3 months of therapy.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~surgery following 3 months of therapy.

This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery following 3 months of therapy. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inverse PCR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sunitinib + Hormonal Ablation Before ProstatectomyExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sunitinib Malate

2008

Completed Phase 3

~3070

Radical Prostatectomy

2005

Completed Phase 2

~4550