Neoplasms

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Symptoms and General Pathology

Prostatic Neoplasms

Neoplasm Metastasis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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Antineoplastic Agents

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Androgens

Hormones

Docetaxel

Leuprolide

Goserelin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Hormonal

Neoadjuvant Hormonal Therapy plus Docetaxel followed by Radical Prostatectomy

Monthly or quarterly LHRH Agonist Depot injection (leuprolide or goserelin acetate) for one year.

Neoadjuvant Hormonal Therapy

35 mg/m2 by vein (IV) on Day 1, 8, 15 and 22 every 6 weeks.

Lance Pagliaro, MD, BA

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.

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.

Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer

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

Participants prostatic specific antigen (PSA) progression-free or event-free survival (that is, freedom from treatment failure) 1 year postoperatively. Treatment failure defined as objective tumor progression during therapy or in year after surgery, confirmed postoperative PSA ⩾1 ngml - 1, or any postoperative radiation, hormonal or other systemic therapy. Participants who did not undergo surgery within 8 weeks of completing 1 year of therapy on protocol (for any reason, including participant refusal) were counted as treatment failure, as were participants whose surgery was begun and aborted.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

All toxicities encountered evaluated according to grading system (0-4) in NCI Common Toxicity Criteria v3.0 and recorded prior to each course of therapy along with duration and treatment. Surgical complications assessed during and within 90 days of procedure by using Clavien grading.

One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m\^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy

Neoadjuvant Hormones + Docetaxel

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

One participant declined presurgical therapy after enrollment and was excluded from analysis.

Lance Pagliaro, MD

One participant of 40 enrolled declined presurgical therapy after enrollment and was excluded from analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer	NCT01076335	Prostate Cancer	Neoadjuvant Hor... Docetaxel	-	M.D. Anderson Cancer Center
Neoadjuvant Hormones + Docetaxel in Node-Positive Prostate Cancer	NCT01076335	Prostate Cancer	Neoadjuvant Hor... Docetaxel	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for neoadjuvant hormonal therapy