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

NCT00055731 | Completed Phase 3 DMC

• 3 other identifiers: GETUG-12 - UC-0160/0203CDR0000270970EU-20238
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 38

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.

Conditions

Prostate Cancer

Keywords

stage III prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (7)

• 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.

  From randomization to disease progression or death, up to 15 years.

• Biological response: Prostate-specific antigen (PSA) level

  The biological response is defined as a non-detectable serum PSA level (\<0.1 ng/ml)

  3 months

• 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

  From randomization to disease progression, up to 15 years.

• 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).

  From randomization to disease progression or death, up to 15 years.

• 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.

  From randomization to death from any cause, up to 15 years.

• 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.

  Throughout study completion, up to 15 years.

• 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.

  At baseline, 3 months, and 1 year

Study Arms (2)

Chemotherapy

EXPERIMENTAL

Drug: bicalutamide; Drug: Goserelin Acetate; Drug: docetaxel; Drug: Estramustine phosphate sodium; Drug: acetylsalicylic acid; Procedure: conventional surgery; Radiation: radiation therapy

Without Chemotherapy

ACTIVE COMPARATOR

Drug: bicalutamide; Drug: Goserelin Acetate; Procedure: conventional surgery; Radiation: radiation therapy

Interventions

bicalutamide DRUG

Also known as: CASODEX®

Chemotherapy; Without Chemotherapy

Goserelin Acetate DRUG

Also known as: ZOLADEX®

Chemotherapy; Without Chemotherapy

docetaxel DRUG

Chemotherapy

Estramustine phosphate sodium DRUG

Chemotherapy

acetylsalicylic acid DRUG

Also known as: Aspirin

Chemotherapy

conventional surgery PROCEDURE

Chemotherapy; Without Chemotherapy

radiation therapy RADIATION

Chemotherapy; Without Chemotherapy

Eligibility Criteria

• Age: 0 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• UNICANCER: lead
• Sanofi: collaborator
• AstraZeneca: collaborator

Study Sites (38)

Centre Paul Papin

Angers, 49100, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Hopital Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Polyclinique du Parc

Cholet, 49300, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94000, France

Location

Clinique Sainte-Marguerite

Hyères, 83400, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, 85025, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Hopital Clinique Claude Bernard

Metz, 57072, France

Location

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Hopital Lapeyronie-CHU Montpellier

Montpellier, 34295, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Centre Catherine de Sienne

Nantes, 02, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital de la Croix St. Simon

Paris, 75020, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Hopital Saint Joseph

Paris, 75674, France

Location

Hopital Tenon

Paris, 75970, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Centre Hospitalier de Rodez

Rodez, 12027, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

CRLCC Nantes - Atlantique

Saint-Herblain, 44805, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Hospitalier Universitaire Bretonneau de Tours

Tours, 37044, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Related Publications (4)

• 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.

  PMID: 22119204 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 26028518 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide; Goserelin; Docetaxel; Estramustine; Aspirin; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Therapeutics

Study Officials

• Karim Fizazi, MD, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2003
• First Posted: March 7, 2003
• Study Start: November 14, 2002
• Primary Completion: December 21, 2010
• Study Completion: December 31, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

FR (38)