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Prostate CancerPhase 3NCT00104715

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

A Phase 3 study testing antiandrogen therapy, docetaxel and goserelin acetate in people with Prostate Cancer, run by UNICANCER at 41 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 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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
antiandrogen therapy, docetaxel and goserelin acetate
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
385 participants
Where
41 sitesFrance
Study dates
18 Oct 2004to 15 Dec 2015
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 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

France41 sites

  • Centre Paul Papin

    Angers, 49100

  • Centre Hospitalier de la Cote Basque

    Bayonne, 64100

  • Hopital Avicenne

    Bobigny, 93009

  • Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Regional Francois Baclesse

    Caen, 14076

  • Polyclinique du Parc

    Cholet, 49300

  • Centre Hospitalier Universitaire Henri Mondor

    Créteil, 94000

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Clinique Sainte-Marguerite

    Hyères, 83400

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, 85025

  • Centre Hospitalier General

    Le Mans, 72037

  • 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

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

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

    Montpellier, 34298

  • Clinique D'Occitanie

    Muret, 31600

  • Centre Catherine de Sienne

    Nantes, 02

  • CRLCC Nantes - Atlantique

    Nantes-Saint Herblain, 44805

  • Centre Antoine Lacassagne

    Nice, 06189

  • C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

    Nîmes, 30029

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Institut Curie Hopital

    Paris, 75248

  • Hopital Saint-Louis

    Paris, 75475

  • Hopital Saint Joseph

    Paris, 75674

  • Hopital Tenon

    Paris, 75970

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Rene Huguenin

    Saint-Cloud, 92211

  • Hopital Foch

    Suresnes, 92151

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Regional de Purpan

    Toulouse, 31059

  • Clinique Du Parc

    Toulouse, 31078

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511

  • Centre Hospitalier Regionale de Vichy

    Vichy, 03201

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
antiandrogen therapy, docetaxel, goserelin acetate, orchiectomy
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage IV 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.

  • antiandrogen therapyDrug

  • docetaxelDrug

  • goserelin acetateDrug

  • orchiectomyProcedure or surgery

Study groups in NCT00104715
Study groupRoleWhat they receive
Hormonotherapy + chemotherapyExperimentalNot described
Receives: Drug: antiandrogen therapy; Drug: docetaxel; Drug: goserelin acetate; Procedure: orchiectomy
Hormonotherapy aloneActive comparatorNot described
Receives: Drug: antiandrogen therapy; Drug: goserelin acetate; Procedure: orchiectomy

What is being measured

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

  1. Overall survival at 36 months

  2. Progression-free survival (biological progression and/or clinical progression) at 24 months

  3. Quality of life

  4. Treatment costs

  5. Toxicity and tolerance

  6. Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays

Timeline

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

  1. First posted4 Mar 2005 (estimated)
  2. Study start18 Oct 2004
  3. Primary completion4 Dec 2011
  4. Study completion15 Dec 2015

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
385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104715
Sponsor's protocol ID
UC-0160/0403
Other IDs
FRE-FNCLCC-GETUG-15/0403, EU-20505
Status last verified
Feb 2021
First submitted
3 Mar 2005
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

  • 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.

  • 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.

    PubMed 25592642

  • 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.

    PubMed 24210084

  • 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.

    PubMed 23306100

  • 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.

    PubMed 22747660

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing antiandrogen therapy, docetaxel and goserelin acetate in people with Prostate Cancer, run by UNICANCER at 41 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 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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?

Overall survival at 36 months. The study lists 6 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 NCT00104715, which also lists 6 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 21 Feb 2021.

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