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Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
antiandrogen therapy
docetaxel
goserelin acetate
orchiectomy
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 adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Metastatic disease Measurable or evaluable disease No brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic WBC ≥ 2,000/mm^3 Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic metastases are present) AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present) Renal Creatinine ≤ 150 μmol/L Cardiovascular No symptomatic coronary disease No congenital cardiac insufficiency No New York Heart Association class III or IV cardiovascular disease No other severe cardiovascular disease Other No severe peripheral neuropathy No active infection No other malignancy within the past 5 years except basal cell skin cancer No familial, social, geographical, or psychological situation that would preclude study compliance and follow-up No other serious disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic prostate cancer Prior chemotherapy allowed provided all of the following are true: Chemotherapy was completed > 1 year ago Prostate-specific antigen level has remained stable No development of metastases within 1 year after completion of chemotherapy Endocrine therapy Prior hormonal therapy within the past 2 months allowed for metastatic prostate cancer Radiotherapy More than 4 weeks since prior radiotherapy to metastatic sites Surgery No prior surgical castration Other No other concurrent investigational drugs

Sites / Locations

  • Centre Paul Papin
  • Centre Hospitalier de la Cote Basque
  • Hopital Avicenne
  • Hopital Saint Andre
  • Institut Bergonie
  • Centre Regional Francois Baclesse
  • Polyclinique du Parc
  • Centre Hospitalier Universitaire Henri Mondor
  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
  • Clinique Sainte-Marguerite
  • Centre Hospitalier Departemental
  • Centre Hospitalier General
  • 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
  • Centre Hospitalier General de Mont de Marsan
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Clinique D'Occitanie
  • CRLCC Nantes - Atlantique
  • Centre Catherine de Sienne
  • Centre Antoine Lacassagne
  • C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
  • Hopital Europeen Georges Pompidou
  • Institut Curie Hopital
  • Hopital Saint-Louis
  • Hopital Saint Joseph
  • Hopital Tenon
  • Institut Jean Godinot
  • Centre Eugene Marquis
  • Centre Rene Huguenin
  • Hopital Foch
  • Institut Claudius Regaud
  • Centre Hospitalier Regional de Purpan
  • Clinique Du Parc
  • Centre Hospitalier Universitaire Bretonneau de Tours
  • Centre Alexis Vautrin
  • Centre Hospitalier Regionale de Vichy
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hormonotherapy + chemotherapy

Hormonotherapy alone

Arm Description

Outcomes

Primary Outcome Measures

Overall survival at 36 months
Progression-free survival (biological progression and/or clinical progression) at 24 months
Quality of life
Treatment costs
Toxicity and tolerance
Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays

Secondary Outcome Measures

Full Information

First Posted
March 3, 2005
Last Updated
February 19, 2021
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00104715
Brief Title
Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
Official Title
Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2004 (Actual)
Primary Completion Date
December 4, 2011 (Actual)
Study Completion Date
December 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.
Detailed Description
OBJECTIVES: Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma treated with hormonal therapy and docetaxel vs hormonal therapy alone. Compare 24-month progression-free survival (biological progression and/or clinical progression) in patients treated with these regimens. Compare the quality of life of patients treated with these regimens. Compare costs of these regimens for these patients. Compare the tolerability of these regimens in these patients. Compare the toxicity profile of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin alone OR goserelin and antiandrogen therapy OR surgical castration. Hormonal therapy continues until the development of hormone resistance. Within 2 months after initiation of hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed. PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Hormonotherapy + chemotherapy
Arm Type
Experimental
Arm Title
Hormonotherapy alone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
antiandrogen therapy
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
goserelin acetate
Intervention Type
Procedure
Intervention Name(s)
orchiectomy
Primary Outcome Measure Information:
Title
Overall survival at 36 months
Title
Progression-free survival (biological progression and/or clinical progression) at 24 months
Title
Quality of life
Title
Treatment costs
Title
Toxicity and tolerance
Title
Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Metastatic disease Measurable or evaluable disease No brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic WBC ≥ 2,000/mm^3 Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic metastases are present) AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present) Renal Creatinine ≤ 150 μmol/L Cardiovascular No symptomatic coronary disease No congenital cardiac insufficiency No New York Heart Association class III or IV cardiovascular disease No other severe cardiovascular disease Other No severe peripheral neuropathy No active infection No other malignancy within the past 5 years except basal cell skin cancer No familial, social, geographical, or psychological situation that would preclude study compliance and follow-up No other serious disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic prostate cancer Prior chemotherapy allowed provided all of the following are true: Chemotherapy was completed > 1 year ago Prostate-specific antigen level has remained stable No development of metastases within 1 year after completion of chemotherapy Endocrine therapy Prior hormonal therapy within the past 2 months allowed for metastatic prostate cancer Radiotherapy More than 4 weeks since prior radiotherapy to metastatic sites Surgery No prior surgical castration Other No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwenaelle Gravis, MD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Paul Papin
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Centre Hospitalier de la Cote Basque
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
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
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
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
City
Dijon
ZIP/Postal Code
21079
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 Hospitalier General
City
Le Mans
ZIP/Postal Code
72037
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
Centre Hospitalier General de Mont de Marsan
City
Mont-de-Marsan
ZIP/Postal Code
40000
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
Clinique D'Occitanie
City
Muret
ZIP/Postal Code
31600
Country
France
Facility Name
CRLCC Nantes - Atlantique
City
Nantes-Saint Herblain
ZIP/Postal Code
44805
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
C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Institut Curie Hopital
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
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 Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92211
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 Regional de Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Clinique Du Parc
City
Toulouse
ZIP/Postal Code
31078
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
Centre Hospitalier Regionale de Vichy
City
Vichy
ZIP/Postal Code
03201
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France

12. IPD Sharing Statement

Citations:
Citation
Gravis G, Fizazi K, Joly F, et al.: Safety results from a phase III trial comparing androgen-deprivation therapy (ADT) plus docetaxel versus ADT alone in hormone-naïve metastatic prostate cancer (GETUG-AFU 15/0403). [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-43, 2010.
Results Reference
result
Citation
Gravis G, Fizazi K, Joly F, et al.: Randomized phase III study comparing docetaxel and androgen deprivation therapy (ADT) versus ADT alone in androgen dependent metastatic prostate cancer (GETUG-15/0403): a French national muticentric study sponsored by the French Federation des Centres. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-161, 2007.
Results Reference
result
PubMed Identifier
25592642
Citation
Campillo-Gimenez B, Buscail C, Zekri O, Laguerre B, Le Prise E, De Crevoisier R, Cuggia M. Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials. Trials. 2015 Jan 16;16:15. doi: 10.1186/s13063-014-0535-7.
Results Reference
derived
PubMed Identifier
24210084
Citation
Trump DL. Commentary on "Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial." Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M, Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France. Lancet Oncol 2013;14(2):149-58 [Epub 2013 Jan 8]. Urol Oncol. 2013 Nov;31(8):1845. doi: 10.1016/j.urolonc.2013.08.011.
Results Reference
derived
PubMed Identifier
23306100
Citation
Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, Latorzeff I, Delva R, Krakowski I, Laguerre B, Rolland F, Theodore C, Deplanque G, Ferrero JM, Pouessel D, Mourey L, Beuzeboc P, Zanetta S, Habibian M, Berdah JF, Dauba J, Baciuchka M, Platini C, Linassier C, Labourey JL, Machiels JP, El Kouri C, Ravaud A, Suc E, Eymard JC, Hasbini A, Bousquet G, Soulie M. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Feb;14(2):149-58. doi: 10.1016/S1470-2045(12)70560-0. Epub 2013 Jan 8.
Results Reference
derived
PubMed Identifier
22747660
Citation
Huang X, Chau CH, Figg WD. Challenges to improved therapeutics for metastatic castrate resistant prostate cancer: from recent successes and failures. J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35.
Results Reference
derived

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Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer

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