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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055731
• Other study ID #: GETUG-12 - UC-0160/0203
• Secondary ID: CDR0000270970EU-
• Status: Completed
• Phase: Phase 3
• Start date: November 14, 2002
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: December 31, 2022
• Est. primary completion date: December 21, 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 0 Years to 79 Years

Eligibility

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

PATIENT CHARACTERISTICS:

Age

• Under 80

Performance status

• ECOG 0-2

Life expectancy

• More than 10 years

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count at least 100,000/mm^3

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

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• bicalutamide

• Goserelin Acetate

• docetaxel

• Estramustine phosphate sodium

• acetylsalicylic acid

Procedure:
• conventional surgery

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Hopital Saint Andre	Bordeaux
France	Institut Bergonie	Bordeaux
France	Hopital Ambroise Pare	Boulogne-Billancourt
France	Centre Regional Francois Baclesse	Caen
France	Polyclinique du Parc	Cholet
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Clinique Sainte-Marguerite	Hyeres
France	Centre Hospitalier Departemental	La Roche Sur Yon
France	Centre Hospital Universitaire Hop Huriez	Lille
France	Centre Hospital Regional Universitaire de Limoges	Limoges
France	Polyclinique des Quatre Pavillons	Lormont
France	Centre Leon Berard	Lyon
France	CHU de la Timone	Marseille
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille
France	Hopital Clinique Claude Bernard	Metz
France	Hopital Notre-Dame de Bon Secours	Metz
France	Centre Hospitalier General de Mont de Marsan	Mont-de-Marsan
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Hopital Lapeyronie-CHU Montpellier	Montpellier
France	Centre Catherine de Sienne	Nantes
France	Centre Antoine Lacassagne	Nice
France	Hopital de la Croix St. Simon	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Saint Joseph	Paris
France	Hopital Tenon	Paris
France	Institut Curie Hopital	Paris
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Centre Hospitalier de Rodez	Rodez
France	Centre Henri Becquerel	Rouen
France	Centre Rene Huguenin	Saint Cloud
France	CRLCC Nantes - Atlantique	Saint-Herblain
France	Hopital Foch	Suresnes
France	Institut Claudius Regaud	Toulouse
France	Centre Hospitalier Universitaire Bretonneau de Tours	Tours
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
UNICANCER	AstraZeneca, Sanofi

Country where clinical trial is conducted

France, 

References & Publications (3)

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 Franc

Fizazi K, Lesaunier F, Delva R, et al.: A phase III trial of docetaxel-estramustine in high-risk localized prostate cancer (GETUG 12 trial): design, tolerance, response, and quality of life (QOL). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7

Fizazi K, Lesaunier F, Delva R, Gravis G, Rolland F, Priou F, Ferrero JM, Houede N, Mourey L, Theodore C, Krakowski I, Berdah JF, Baciuchka M, Laguerre B, Flechon A, Ravaud A, Cojean-Zelek I, Oudard S, Labourey JL, Lagrange JL, Chinet-Charrot P, Linassier — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.	From randomization to disease progression or death, up to 15 years.
Primary	Biological response: Prostate-specific antigen (PSA) level	The biological response is defined as a non-detectable serum PSA level (<0.1 ng/ml)	3 months
Primary	Cancer progression as measured by ultrasound	Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment	From randomization to disease progression, up to 15 years.
Primary	Clinical progression-free survival	The clinical progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (based on bone scintigraphy, pelvic scan, or MRI evaluation).	From randomization to disease progression or death, up to 15 years.
Primary	Overall survival	The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care.	From randomization to death from any cause, up to 15 years.
Primary	Acute and late toxicity during the study	The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.	Throughout study completion, up to 15 years.
Primary	Quality of life questionnaire - Core 30 (QLQ-C30)	Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.; The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.; All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	At baseline, 3 months, and 1 year