Clinical trial NCT01076335: Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer
Official title: Phase II Study of Neoadjuvant Hormonal Therapy Plus Docetaxel Followed by Radical Prostatectomy for Men With Proven or Suspected Node-positive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Neoadjuvant Hormonal Therapy
Docetaxel
Taxotere
Chemotherapy
Radical Prostatectomy
Node-positive Prostate Cancer
Androgen-dependent prostate cancer
Lymph node metastases
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-02-26
Enrollment: 40
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical research study is to find out if a therapy using docetaxel chemotherapy with hormonal therapy taken before your scheduled surgery is beneficial to treatment of prostate cancer. The safety of this combination will also be studied.

Detailed description: 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.

Eligibility criteria: 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 included.
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 permitted.
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 institution.
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 New York Heart Association (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 years.
9. Overt psychosis, mental disability or otherwise incompetent to give informed consent.

Primary outcomes:
measure: Number of Participants Progression Free at 1 Year
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lance Pagliaro, MD, BA
role: STUDY_CHAIR
References: