Clinical trial NCT00055731: Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: stage III prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: Sanofi
name: AstraZeneca
First posted: 2003-03-07
Enrollment: 413
Sex: MALE
Minimum age (years): 0
Maximum age (years): 79
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

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

Primary outcomes:
measure: Progression-free survival
timeFrame: From randomization to disease progression or death, up to 15 years.
measure: Biological response: Prostate-specific antigen (PSA) level
timeFrame: 3 months
measure: Cancer progression as measured by ultrasound
timeFrame: From randomization to disease progression, up to 15 years.
measure: Clinical progression-free survival
timeFrame: From randomization to disease progression or death, up to 15 years.
measure: Overall survival
timeFrame: From randomization to death from any cause, up to 15 years.
measure: Acute and late toxicity during the study
timeFrame: Throughout study completion, up to 15 years.
measure: Quality of life questionnaire - Core 30 (QLQ-C30)
timeFrame: At baseline, 3 months, and 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Bordeaux
country: France
facility: Institut Bergonie
city: Boulogne-Billancourt
country: France
facility: Hopital Ambroise Pare
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Cholet
country: France
facility: Polyclinique du Parc
city: Creteil
country: France
facility: Centre Hospitalier Universitaire Henri Mondor
city: Hyeres
country: France
facility: Clinique Sainte-Marguerite
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental
city: Lille
country: France
facility: Centre Hospital Universitaire Hop Huriez
city: Limoges
country: France
facility: Centre Hospital Regional Universitaire de Limoges
city: Lormont
country: France
facility: Polyclinique des Quatre Pavillons
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Marseille
country: France
facility: CHU de la Timone
city: Metz
country: France
facility: Hopital Notre-Dame de Bon Secours
city: Metz
country: France
facility: Hopital Clinique Claude Bernard
city: Mont-de-Marsan
country: France
facility: Centre Hospitalier General de Mont de Marsan
city: Montpellier
country: France
facility: Hopital Lapeyronie-CHU Montpellier
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital de la Croix St. Simon
city: Paris
country: France
facility: Institut Curie Hopital
city: Paris
country: France
facility: Hopital Saint Joseph
city: Paris
country: France
facility: Hopital Tenon
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rodez
country: France
facility: Centre Hospitalier de Rodez
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Saint-Herblain
country: France
facility: CRLCC Nantes - Atlantique
city: Suresnes
country: France
facility: Hopital Foch
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Tours
country: France
facility: Centre Hospitalier Universitaire Bretonneau de Tours
city: Vandoeuvre-les-Nancy
country: France
facility: Centre Alexis Vautrin
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim Fizazi, MD, PhD
role: STUDY_CHAIR
References:
citation: 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 C, Deplanque G, Beuzeboc P, Geneve J, Davin JL, Tournay E, Culine S. A phase III trial of docetaxel-estramustine in high-risk localised prostate cancer: a planned analysis of response, toxicity and quality of life in the GETUG 12 trial. Eur J Cancer. 2012 Jan;48(2):209-17. doi: 10.1016/j.ejca.2011.10.015. Epub 2011 Nov 24.
citation: 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, 2010, San Francisco, California. A-7, 2010.
citation: 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.
citation: Fizazi K, Faivre L, 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, Chinet-Charrot P, Legouffe E, Lagrange JL, Linassier C, Deplanque G, Beuzeboc P, Davin JL, Martin AL, Habibian M, Laplanche A, Culine S. Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial. Lancet Oncol. 2015 Jul;16(7):787-94. doi: 10.1016/S1470-2045(15)00011-X. Epub 2015 May 28.