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Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

2014-08-27 03:55:27 | BioPortfolio

Summary

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

Description

OBJECTIVES:

- Compare the 8-year survival rate, in terms of clinical and biological remission, of patients with locally advanced prostate cancer or with a high risk of relapse treated with neoadjuvant releasing factor agonist therapy and antiandrogen therapy with or without docetaxel and estramustine given before local radiotherapy or prostatectomy.

- Compare the prostate-specific antigen level at 3 months in patients treated with these regimens.

- Compare cancer progression by ultrasound in patients treated with these regimens.

- Compare survival without clinical remission of patients treated with these regimens.

- Compare the overall survival of patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Gleason score (7 or under vs over 7), T stage (T1 or T2 vs T3 or T4), prostate-specific antigen level (20 ng/mL or less vs greater than 20 ng/mL), and lymph node involvement (N0 vs N1 or N2). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral antiandrogen therapy comprising nilutamide twice daily or bicalutamide once daily or flutamide 3 times daily or cyproterone 4 times daily. Patients also receive docetaxel IV over 1 hour on day 2 and estramustine on days 1-5. Treatment repeats every 21 days for a total of 4 courses. Patients also receive luteinizing hormone-releasing hormone (LHRH) therapy IV comprising buserelin subcutaneously (SC) every 2 months or triptorelin, leuprolide, or goserelin SC every 3 months.

- Arm II: Patients receive antiandrogen and LHRH therapy as in arm I. Beginning approximately 21 days after chemotherapy is completed, patients with N0 disease undergo radiotherapy 5 days a week for 6-7 weeks or radical prostatectomy. Patients with N1 or N2 disease undergo radiotherapy or no further local treatment.

Hormonal therapy continues in both arms for 3 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 3 months, and at 1 year.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 250 patients (125 per treatment arm) will be accrued for this study within 3 years.

Study Design

Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

bicalutamide, buserelin, cyproterone acetate, docetaxel, estramustine phosphate sodium, flutamide, goserelin, leuprolide acetate, nilutamide, triptorelin, conventional surgery, neoadjuvant therapy, radiation therapy

Location

Centre Paul Papin
Angers
France
49100

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:27-0400

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Medical and Biotech [MESH] Definitions

An anti-androgen that, in the form of its acetate (CYPROTERONE ACETATE), also has progestational properties. It is used in the treatment of hypersexuality in males, as a palliative in prostatic carcinoma, and, in combination with estrogen, for the therapy of severe acne and hirsutism in females.

A family of highly conserved and widely expressed sodium-phosphate cotransporter proteins. They are electrogenic sodium-dependent transporters of phosphate that were originally identified as retroviral receptors in HUMANS and have been described in yeast and many other organisms.

The trihydrate sodium salt of acetic acid, which is used as a source of sodium ions in solutions for dialysis and as a systemic and urinary alkalizer, diuretic, and expectorant.

A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.

An agent with anti-androgen and progestational properties. It shows competitive binding with dihydrotestosterone at androgen receptor sites.

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