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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104715
• Other study ID #: UC-0160/0403
• Secondary ID: FRE-FNCLCC-GETUG
• Status: Completed
• Phase: Phase 3
• Start date: October 18, 2004
• Est. completion date: December 15, 2015

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: December 15, 2015
• Est. primary completion date: December 4, 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• antiandrogen therapy

• docetaxel

• goserelin acetate

Procedure:
• orchiectomy

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	Centre Hospitalier de la Cote Basque	Bayonne
France	Hopital Avicenne	Bobigny
France	Hopital Saint Andre	Bordeaux
France	Institut Bergonie	Bordeaux
France	Centre Regional Francois Baclesse	Caen
France	Polyclinique du Parc	Cholet
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon
France	Clinique Sainte-Marguerite	Hyeres
France	Centre Hospitalier Departemental	La Roche Sur Yon
France	Centre Hospitalier General	Le Mans
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 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	Clinique D'Occitanie	Muret
France	Centre Catherine de Sienne	Nantes
France	CRLCC Nantes - Atlantique	Nantes-Saint Herblain
France	Centre Antoine Lacassagne	Nice
France	C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau	Nimes
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Saint Joseph	Paris
France	Hopital Saint-Louis	Paris
France	Hopital Tenon	Paris
France	Institut Curie Hopital	Paris
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	Centre Rene Huguenin	Saint Cloud
France	Hopital Foch	Suresnes
France	Centre Hospitalier Regional de Purpan	Toulouse
France	Clinique Du Parc	Toulouse
France	Institut Claudius Regaud	Toulouse
France	Centre Hospitalier Universitaire Bretonneau de Tours	Tours
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Centre Hospitalier Regionale de Vichy	Vichy
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & Publications (2)

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 t

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 S

Outcome

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