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

Sponsor

UNICANCER (Other)

Overall Status

Completed

CT.gov ID

NCT00104715

Collaborator

(none)

385

Enrollment

Locations

Arms

133.9

Actual Duration (Months)

9.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: antiandrogen therapy Drug: docetaxel Drug: goserelin acetate Procedure: orchiectomy	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

385 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers

Actual Study Start Date :

Oct 18, 2004

Actual Primary Completion Date :

Dec 4, 2011

Actual Study Completion Date :

Dec 15, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hormonotherapy + chemotherapy	Drug: antiandrogen therapy Drug: docetaxel Drug: goserelin acetate Procedure: orchiectomy
Active Comparator: Hormonotherapy alone	Drug: antiandrogen therapy Drug: goserelin acetate Procedure: orchiectomy

Arm

Intervention/Treatment

Experimental: Hormonotherapy + chemotherapy

Drug: antiandrogen therapy

Drug: docetaxel

Drug: goserelin acetate

Procedure: orchiectomy

Active Comparator: Hormonotherapy alone

Drug: antiandrogen therapy

Drug: goserelin acetate

Procedure: orchiectomy

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Paul Papin	Angers	France	49100
2	Centre Hospitalier de la Cote Basque	Bayonne	France	64100
3	Hopital Avicenne	Bobigny	France	93009
4	Hopital Saint Andre	Bordeaux	France	33075
5	Institut Bergonie	Bordeaux	France	33076
6	Centre Regional Francois Baclesse	Caen	France	14076
7	Polyclinique du Parc	Cholet	France	49300
8	Centre Hospitalier Universitaire Henri Mondor	Creteil	France	94000
9	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon	France	21079
10	Clinique Sainte-Marguerite	Hyeres	France	83400
11	Centre Hospitalier Departemental	La Roche Sur Yon	France	85025
12	Centre Hospitalier General	Le Mans	France	72037
13	Centre Hospital Regional Universitaire de Limoges	Limoges	France	87042
14	Polyclinique des Quatre Pavillons	Lormont	France	33310
15	Centre Leon Berard	Lyon	France	69008
16	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	Marseille	France	13273
17	CHU de la Timone	Marseille	France	13385
18	Hopital Notre-Dame de Bon Secours	Metz	France	57038
19	Centre Hospitalier General de Mont de Marsan	Mont-de-Marsan	France	40000
20	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier	France	34298
21	Clinique D'Occitanie	Muret	France	31600
22	CRLCC Nantes - Atlantique	Nantes-Saint Herblain	France	44805
23	Centre Catherine de Sienne	Nantes	France	02
24	Centre Antoine Lacassagne	Nice	France	06189
25	C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau	Nimes	France	30029
26	Hopital Europeen Georges Pompidou	Paris	France	75015
27	Institut Curie Hopital	Paris	France	75248
28	Hopital Saint-Louis	Paris	France	75475
29	Hopital Saint Joseph	Paris	France	75674
30	Hopital Tenon	Paris	France	75970
31	Institut Jean Godinot	Reims	France	51056
32	Centre Eugene Marquis	Rennes	France	35042
33	Centre Rene Huguenin	Saint Cloud	France	92211
34	Hopital Foch	Suresnes	France	92151
35	Institut Claudius Regaud	Toulouse	France	31052
36	Centre Hospitalier Regional de Purpan	Toulouse	France	31059
37	Clinique Du Parc	Toulouse	France	31078
38	Centre Hospitalier Universitaire Bretonneau de Tours	Tours	France	37044
39	Centre Alexis Vautrin	Vandoeuvre-les-Nancy	France	54511
40	Centre Hospitalier Regionale de Vichy	Vichy	France	03201
41	Institut Gustave Roussy	Villejuif	France	F-94805