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Prostate CancerPhase 3NCT00055731

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

A Phase 3 study testing bicalutamide, Goserelin Acetate and docetaxel in people with Prostate Cancer, run by UNICANCER at 38 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 79 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
bicalutamide, Goserelin Acetate and docetaxel
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
413 participants
Where
38 sitesFrance
Study dates
14 Nov 2002to 31 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 79 years
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

France38 sites

  • Centre Paul Papin

    Angers, 49100

  • Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • Hopital Ambroise Pare

    Boulogne-Billancourt, F-92104

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Polyclinique du Parc

    Cholet, 49300

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94000

  • Clinique Sainte-Marguerite

    Hyères, 83400

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, 85025

  • Centre Hospital Universitaire Hop Huriez

    Lille, 59037

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Polyclinique des Quatre Pavillons

    Lormont, 33310

  • Centre Leon Berard

    Lyon, 69008

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

    Marseille, 13273

  • CHU de la Timone

    Marseille, 13385

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • Hopital Clinique Claude Bernard

    Metz, 57072

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

  • Hopital Lapeyronie-CHU Montpellier

    Montpellier, 34295

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

    Montpellier, 34298

  • Centre Catherine de Sienne

    Nantes, 02

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital de la Croix St. Simon

    Paris, 75020

  • Institut Curie Hopital

    Paris, 75248

  • Hopital Saint Joseph

    Paris, 75674

  • Hopital Tenon

    Paris, 75970

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Hospitalier de Rodez

    Rodez, 12027

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • CRLCC Nantes - Atlantique

    Saint-Herblain, 44805

  • Hopital Foch

    Suresnes, 92151

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

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

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
Being tested
bicalutamide, Goserelin Acetate, docetaxel, Estramustine phosphate sodium, acetylsalicylic acid
Keywords
stage III prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bicalutamideDrug

    Also called CASODEX®

  • Goserelin AcetateDrug

    Also called ZOLADEX®

  • docetaxelDrug

  • Estramustine phosphate sodiumDrug

  • acetylsalicylic acidDrug

    Also called Aspirin

  • conventional surgeryProcedure or surgery

  • radiation therapyRadiation

Study groups in NCT00055731
Study groupRoleWhat they receive
ChemotherapyExperimentalNot described
Receives: Drug: bicalutamide; Drug: Goserelin Acetate; Drug: docetaxel; Drug: Estramustine phosphate sodium; Drug: acetylsalicylic acid; Procedure: conventional surgery; Radiation: radiation therapy
Without ChemotherapyActive comparatorNot described
Receives: Drug: bicalutamide; Drug: Goserelin Acetate; Procedure: conventional surgery; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Biological response: Prostate-specific antigen (PSA) level

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

    Measured: 3 months

  3. 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

    Measured: From randomization to disease progression, up to 15 years.

  4. 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).

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

  5. 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.

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

  6. 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.

    Measured: Throughout study completion, up to 15 years.

  7. 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.

    Measured: At baseline, 3 months, and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2003 (estimated)
  2. Study start14 Nov 2002
  3. Primary completion21 Dec 2010
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00055731
Sponsor's protocol ID
GETUG-12 - UC-0160/0203
Other IDs
CDR0000270970, EU-20238
Status last verified
Jan 2023
First submitted
6 Mar 2003
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22119204

  • 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.

  • 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.

  • 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.

    PubMed 26028518

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bicalutamide, Goserelin Acetate and docetaxel in people with Prostate Cancer, run by UNICANCER at 38 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From randomization to disease progression or death, up to 15 years.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00055731, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.

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