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Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

Thank you

Trial Information

Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer


The Study Drugs:

Sunitinib malate is designed to block pathways that control important events such as the
growth of blood vessels that are essential for the growth of cancer.

Luteinizing Hormone-Releasing Hormone (LHRH) Analogues like Lupron® (leuprolide) and
Zoladex® (goserelin) are hormonal treatments used to help stop the body from making
testosterone (male sex hormones) in the body. Prostate cancer cells need testosterone to
survive.

Anti-Androgen drugs, like Casodex® (bicalutamide) also stop cell growth by blocking male
hormones like testosterone.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will be assigned to a study
group. The group you are assigned to and dose of sunitinib malate you receive will depend on
when you join this study. Three (3) dose levels of sunitinib malate will be tested. The
first group of participants will receive the lowest dose of sunitinib malate. The next
group enrolled will receive a higher dose of sunitinib malate, if no intolerable side
effects were seen.

Before you begin taking sunitinib, you will begin receiving hormone therapy. You will
receive leuprolide or goserelin. Leuprolide is given through a needle in your muscle, and
goserelin is given through a needle under the skin in the abdomen. You will receive 1 of
these injections every 3 months. Which hormonal drug you are given (leuprolide or
goserelin) will be assigned by your doctor and/or will depend on your insurance coverage.

You may also receive bicalutamide. This will be left up to the doctor. You will take
bicalutamide by mouth once a day for 2 weeks (with or without food).

After at least 4 weeks of hormone therapy have been given, you will begin taking sunitinib
malate in combination with the hormone therapy. You will take sunitinib malate once a day
(either with or without food) for 16 weeks in a row.

Radiation Therapy:

After 4 weeks of combined treatment with sunitinib and hormone therapy, you will begin
radiation treatments. Radiation treatments will be given once a day, 5 days a week, for
about 8 weeks. Each treatment will take 20-30 minutes. This procedure will be discussed
with you in more detail. You will continue taking sunitinib and hormone therapy while you
are on radiation treatments.

Study Visits:

On the day you start treatment with sunitinib, you will have the following tests and
procedures performed:

- You will have a physical exam, including measurements of your blood pressure and
weight.

- You will be asked about any side effects you may have had since your last visit.

- Blood (about 1 teaspoon) will be drawn for routine tests.

About Day 15 of treatment with sunitinib, and on the day you begin radiation therapy (before
your first treatment), you will have the following tests and procedures performed:

- You will have a physical exam, including measurements of your blood pressure and
weight.

- You will be asked about any side effects you may have had since your last visit.

- Blood (about 2 teaspoons) will be drawn for routine tests.

Every 2 weeks during radiation therapy, you will have the following tests and procedures
performed:

- You will have a physical exam, including measurements of your blood pressure and weight
(every 2 weeks)

- You will have blood drawn (about 2 teaspoons) for routine testing.

- You will be asked about any side effects you may have had since your last visit.

About 4 weeks after you stop radiation therapy, you will have the following test and
procedures performed:

- You will have a physical exam, including measurements of your blood pressure and
weight.

- Blood (about 2 teaspoons) and urine will be collected for routine tests. The blood
testing will include measurement of PSA and testosterone levels.

- You will be asked about any side effects you have had since your last visit.

Length of Study:

You will continue taking sunitinib malate on this study for a total of 16 weeks. Radiation
treatments will last for up to 8 weeks. Hormone injections will continue for a period of 2
years. You will be taken off this study if intolerable side effects occur or the disease
gets worse.

Long-Term Follow-up:

You will be followed every 6 months via telephone call and/or a review of your medical
record. If contacted, you will be asked about any side effects you have had, or therapies
you may have had since stopping treatment on this study. You will be followed for up to 10
years once you have taken sunitinib malate for 20 weeks.

This is an investigational study. Sunitinib malate is FDA approved and commercially
available for the treatment of adults with kidney cancer.

Bicalutamide, leuprolide, and goserelin are FDA approved and commercially available for use
in prostate cancer.

Up to 22 patients will be enrolled in this multicenter trial. Up to 12 will be enrolled at
MD Anderson.


Inclusion Criteria:



1. Adenocarcinoma of the prostate with the following high-risk features are eligible:
clinical T2c, clinical or pathological T3 or T4 disease OR Gleason 8-10 disease OR
PSA > 20ng/ml.

2. Patients must have no evidence of metastatic disease by clinical and radiological
staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.

3. ECOG Performance Status 0-1

4. Calculated Creatinine clearance > 35cc/min, Absolute neutrophil count > 1,500/mm^3,
Platelets >/= 100,000/mm^3, AST/ALT < 2.5 x UNL, Total bilirubin WNL.

5. No standard contraindications to radiation therapy including prior radiation therapy,
inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular
disease.

6. Patients must be at least 18 years of age

7. Patients may have had up to 8 weeks of hormonal therapy defined as
luteinizing-hormone releasing hormone or other medical castration therapy prior to
registration.

Exclusion Criteria:

1. Prior VEGFR/PDGFR inhibitor or other investigational therapy.

2. Inability to take oral medication

3. Chronically uncontrolled hypertension, defined conventionally as consistent/repeated
systolic pressures above 140 mmHg or diastolic pressures above 90 mmHg despite
anti-hypertensive therapy. This may be established with home BP readings. There is no
criterion related to a specific BP result required for eligibility, nor are acute BP
elevations that are related to iatrogenic causes, acute pain, or other transient
reversible causes considered an exclusion criteria. The intent is to exclude patients
with chronically uncontrolled hypertension that might be further exacerbated by
Sunitinib.

4. Left Ventricular Ejection Fraction symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in
the last 12 months.

5. Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or
liver cirrhosis.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT)

Outcome Time Frame:

8 week period of combined hormone ablation, Sunitinib, and radiation therapy

Safety Issue:

Yes

Principal Investigator

Paul Corn, MD, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-0684

NCT ID:

NCT00631527

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Radiation Therapy
  • RT
  • Radiotherapy
  • Hormone Ablation
  • Sunitinib Malate
  • Leuprolide
  • Lupron
  • Zoladex
  • Goserelin
  • Casodex
  • Bicalutamide
  • SU011248
  • Sutent
  • Angiogenesis inhibitor
  • Prostatic Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030