search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
bicalutamide
Goserelin Acetate
docetaxel
Estramustine phosphate sodium
acetylsalicylic acid
conventional surgery
radiation therapy
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage III prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

0 Years - 79 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Paul Papin
  • Hopital Saint Andre
  • Institut Bergonie
  • Hopital Ambroise Pare
  • Centre Regional Francois Baclesse
  • Polyclinique du Parc
  • Centre Hospitalier Universitaire Henri Mondor
  • Clinique Sainte-Marguerite
  • Centre Hospitalier Departemental
  • Centre Hospital Universitaire Hop Huriez
  • Centre Hospital Regional Universitaire de Limoges
  • Polyclinique des Quatre Pavillons
  • Centre Leon Berard
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • CHU de la Timone
  • Hopital Notre-Dame de Bon Secours
  • Hopital Clinique Claude Bernard
  • Centre Hospitalier General de Mont de Marsan
  • Hopital Lapeyronie-CHU Montpellier
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Centre Catherine de Sienne
  • Centre Antoine Lacassagne
  • Hopital Europeen Georges Pompidou
  • Hopital de la Croix St. Simon
  • Institut Curie Hopital
  • Hopital Saint Joseph
  • Hopital Tenon
  • Institut Jean Godinot
  • Centre Eugene Marquis
  • Centre Hospitalier de Rodez
  • Centre Henri Becquerel
  • Centre Rene Huguenin
  • CRLCC Nantes - Atlantique
  • Hopital Foch
  • Institut Claudius Regaud
  • Centre Hospitalier Universitaire Bretonneau de Tours
  • Centre Alexis Vautrin
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chemotherapy

Without Chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

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.
Biological response: Prostate-specific antigen (PSA) level
The biological response is defined as a non-detectable serum PSA level (<0.1 ng/ml)
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
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).
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 6, 2003
Last Updated
January 17, 2023
Sponsor
UNICANCER
Collaborators
Sanofi, AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00055731
Brief 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
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 14, 2002 (Actual)
Primary Completion Date
December 21, 2010 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
Sanofi, AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage III prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy
Arm Type
Experimental
Arm Title
Without Chemotherapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
bicalutamide
Other Intervention Name(s)
CASODEX®
Intervention Type
Drug
Intervention Name(s)
Goserelin Acetate
Other Intervention Name(s)
ZOLADEX®
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
Estramustine phosphate sodium
Intervention Type
Drug
Intervention Name(s)
acetylsalicylic acid
Other Intervention Name(s)
Aspirin
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
From randomization to disease progression or death, up to 15 years.
Title
Biological response: Prostate-specific antigen (PSA) level
Description
The biological response is defined as a non-detectable serum PSA level (<0.1 ng/ml)
Time Frame
3 months
Title
Cancer progression as measured by ultrasound
Description
Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment
Time Frame
From randomization to disease progression, up to 15 years.
Title
Clinical progression-free survival
Description
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).
Time Frame
From randomization to disease progression or death, up to 15 years.
Title
Overall survival
Description
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.
Time Frame
From randomization to death from any cause, up to 15 years.
Title
Acute and late toxicity during the study
Description
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.
Time Frame
Throughout study completion, up to 15 years.
Title
Quality of life questionnaire - Core 30 (QLQ-C30)
Description
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.
Time Frame
At baseline, 3 months, and 1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Fizazi, MD, PhD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Hopital Saint Andre
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Ambroise Pare
City
Boulogne-Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Polyclinique du Parc
City
Cholet
ZIP/Postal Code
49300
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Clinique Sainte-Marguerite
City
Hyeres
ZIP/Postal Code
83400
Country
France
Facility Name
Centre Hospitalier Departemental
City
La Roche Sur Yon
ZIP/Postal Code
85025
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Polyclinique des Quatre Pavillons
City
Lormont
ZIP/Postal Code
33310
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
Hopital Clinique Claude Bernard
City
Metz
ZIP/Postal Code
57072
Country
France
Facility Name
Centre Hospitalier General de Mont de Marsan
City
Mont-de-Marsan
ZIP/Postal Code
40000
Country
France
Facility Name
Hopital Lapeyronie-CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
02
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital de la Croix St. Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Saint Joseph
City
Paris
ZIP/Postal Code
75674
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Centre Hospitalier de Rodez
City
Rodez
ZIP/Postal Code
12027
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Saint-Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Hospitalier Universitaire Bretonneau de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22119204
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
26028518
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs