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Phase II Study of Neoadjuvant Hormonal Therapy Plus Docetaxel Followed by Radical Prostatectomy for Men With Proven or Suspected Node-positive Prostate Cancer

Phase 2
Open (Enrolling)
Prostate Cancer

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Trial Information

Phase II Study of Neoadjuvant Hormonal Therapy Plus Docetaxel Followed by Radical Prostatectomy for Men With Proven or Suspected Node-positive Prostate Cancer

Advanced prostate cancer may be responsive to a combination of hormonal and chemotherapy
treatments. Researchers believe that the use of chemotherapy and hormonal therapy before
your scheduled surgery may help to affect or delay the progression of prostate cancer.

Before surgery, you will have imaging studies, including a chest x-ray, CT scan and a bone
scan. You may also have an MRI scan. These tests are being done to check on the status of
the disease. You will also have 3 tablespoons of blood drawn for routine blood tests,
before treatment.

All treatment will be given on an outpatient basis. Treatment should start as soon as
possible, within 14 days after registration. You will receive hormonal treatment once a
month for the 12 months before your surgery. Hormonal treatments will not continue after
the surgery.

You will be given dexamethasone, Benadryl® (diphenylhydramine) and Pepcid® (famotidine) , by
a vein in your arm or by central line in a vein before your therapy begins with docetaxel on
Day 1 of the first treatment cycle. Dexamethasone will help decrease bone marrow
inflammation. Diphenhydramine helps prevent allergic reactions. Famotidine protects you
against stomach irritation by decreasing the amount of acid in your stomach.

Docetaxel will be given through a needle in your vein (IV) once a week during the first 4
weeks of each 6-week period (called a study cycle). Each dose of docetaxel will take about
an hour to be given. The total treatment time to complete the docetaxel will be 3 study
cycles (18 weeks). Before each 6-week study cycle with docetaxel, you will come to the
clinic for a physical exam and routine blood tests (2 tablespoons).

After your treatment with docetaxel and hormones, you will then have an operation to remove
the prostate gland and the tumor. Your doctor will discuss the surgical procedure with you
in detail and explain the risks of the operation. You will need to sign a separate consent
form before undergoing the surgical procedure.

After surgery, you will be closely checked for any possible side effects. After completion
of the treatment, you will be monitored every 3 months for the first year and every 6 months
for the second year. You will also have 2 tablespoons of blood drawn for routine blood test
monitoring at every follow-up visit.

This is an investigational study. Docetaxel and the hormone treatments used in this study
are FDA approved medications for the treatment of prostate cancer. Up to 40 patients will
take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patients with adenocarcinoma of the prostate that in the opinion of the surgeon could
be resectable after response to systemic therapy. Ductal carcinoma variant is

2. All patients must be regarded as acceptable anesthetic risk for radical prostatectomy
and confirm their intention to undergo radical prostatectomy at the end of the
neoadjuvant therapy.

3. Zubrod performance status 2 or better.

4. All patients must have thorough tumor staging and meet one of the following criteria:
a) Either lymph node biopsy or lymph node dissection demonstrating presence of lymph
node metastasis. b) Pelvic or retroperitoneal lymphadenopathy >/= 2.0 cm visualized
on CT scan (biopsy is not required if >/= 2.0 cm and in typical distribution) c)
Primary tumor Gleason score >/= 8 and serum PSA concentration >/= 25 ng/ml,
indicating high risk of occult lymph node metastases.

5. (# 4 cont'd) d) Primary tumor stage T3 and Gleason score >/= 7, indicating high risk
of occult lymph node metastases. e) Primary tumor stage T4 indicating high risk of
occult lymph node metastases.

6. Prior hormonal therapy up to 6 months is permitted. No concurrent ketoconazole is

7. 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; adequate
hepatic function defined with a total bilirubin of < 1.5 mg/dl and AST/ALT < 2X the
upper limits of normal; adequate renal function defined as serum creatinine clearance
> 40 cc/min (measured or calculated).

8. Patients must sign an informed consent indicating that they are aware of the
investigational nature of this study, in keeping with the policies of the

9. All patients must be evaluated in the Department of Urology and Department of
Genitourinary Medical Oncology prior to signing informed consent.

Exclusion Criteria:

1. Patients with small cell or sarcomatoid histology.

2. Patients with clinical or radiological evidence of bone or other extranodal
metastasis (M1b or M1c).

3. Prior chemotherapy.

4. Patients with severe or uncontrolled intercurrent infection.

5. Patients with NYHA Class III/IV congestive heart failure, unstable angina or history
of myocardial infarction within the last 6 months.

6. Contraindications to corticosteroids.

7. Uncontrolled severe hypertension, persistently uncontrolled diabetes mellitus,
oxygen-dependent lung disease, chronic liver disease or HIV infection.

8. Second malignancies (excluding non-melanoma skin cancer) unless disease-free for 3

9. Overt psychosis, mental disability or otherwise incompetent to give informed consent.

Type of Study:


Study Design:

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

Outcome Measure:

Number of Patients Progression Free at 1 Year

Outcome Time Frame:

1 Year

Safety Issue:


Principal Investigator

Lance Pagliaro, MD, BA

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Neoadjuvant Hormonal Therapy
  • Docetaxel
  • Taxotere
  • Chemotherapy
  • Radical Prostatectomy
  • Node-positive Prostate Cancer
  • Androgen-dependent prostate cancer
  • Lymph node metastases
  • Prostatic Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030