Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	Under 80	Other	FRE-FNCLCC-GETUG-12/0203 EU-20238, NCT00055731

Objectives

1. 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.
2. Compare the prostate-specific antigen level at 3 months in patients treated with these regimens.
3. Compare cancer progression by ultrasound in patients treated with these regimens.
4. Compare survival without clinical remission of patients treated with these regimens.
5. Compare the overall survival of patients treated with these regimens.
6. Compare the toxicity of these regimens in these patients.
7. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed adenocarcinoma of the prostate
  • Locally advanced disease or at high risk for relapse
• No clinically or radiologically suspected metastases
• Prior lymphadenectomy required
• Meets at least 1 of the following criteria for poor prognosis:
  • Gleason score greater than 7
  • T3 or T4 disease
  • Prostate-specific antigen greater than 20 ng/mL
  • N1 disease

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent immunotherapy

Chemotherapy

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy

• No prior hormonal therapy
• No other concurrent hormonal therapy

Radiotherapy

• Not specified

Surgery

• See Disease Characteristics

Other

• No other concurrent anticancer therapy

Patient Characteristics:

Age

• Under 80

Performance status

• ECOG 0-2

Life expectancy

• More than 10 years

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• AST and ALT no greater than 1.5 times upper limit of normal (ULN)
• Bilirubin no greater than ULN

Renal

• Creatinine less than 1.6 mg/dL

  OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular

• No uncontrolled or severe cardiovascular disease
• No prior thrombosis

Pulmonary

• No prior pulmonary embolus

Other

• No active infection
• No intolerance to aspirin
• No other prior malignancy except basal cell skin cancer
• No physical or psychological condition that would preclude study compliance

Expected Enrollment

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

Outcomes

Survival rate, in terms of clinical and biological remission at 8 years
Prostate-specific antigen level at 3 months
Cancer progression as measured by ultrasound
Survival without clinical remission
Overall survival
Toxicity
Quality of life

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.

Fizazi K, Gravis G, Culine S: The GETUG 12 trial, a phase III randomized trial of docetaxel-estramustine in high-risk localized prostate cancer: clinical design and current status. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-153, 2006.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Karim Fizazi, MD, PhD, Protocol chair		Ph: 33-1-4211-6264 Email: fizazi@igr.fr

Registry Information
Official Title		Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse
Trial Start Date		2002-11-01
Registered in ClinicalTrials.gov		NCT00055731
Date Submitted to PDQ		2003-01-14
Information Last Verified		2008-04-27

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