Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00104741
Recruitment Status : Unknown
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 4, 2005
Last Update Posted : February 21, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving triptorelin and flutamide together with radiation therapy may be an effective treatment for prostate cancer. It is not yet known whether giving triptorelin and flutamide together with external-beam radiation therapy is more effective than external-beam radiation therapy alone in treating prostate cancer.

PURPOSE: This randomized phase III trial is studying triptorelin, flutamide, and external-beam radiation therapy to see how well they work compared to external-beam radiation therapy alone in treating patients with stage II or stage III prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: flutamide Drug: triptorelin Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the impact of neoadjuvant androgen blockade therapy comprising triptorelin and flutamide followed by conformal external beam radiotherapy and continued androgen blockage therapy vs conformal external beam radiotherapy alone in patients with stage II or III prostate cancer.
  • Compare the survival rate, in terms of 5-year clinical or biological remission, in patients treated with these regimens.
  • Compare overall survival in patients treated with these regimens.
  • Compare acute and late toxicity of these regimens in these patients.
  • Compare quality of life of patients treated with these regimens.
  • Determine the value and time-delay to obtain prostate-specific antigen nadir in patients treated with external beam radiotherapy alone.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo conformal external beam radiotherapy.
  • Arm II: Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily. Androgen blockade therapy continues for a total of 4 months. Two months after initiation of androgen blockade therapy, patients undergo conformal external beam radiotherapy.

Quality of life is assessed.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Multicentre Randomized Trial Assessing the Efficacy of a Short Neoadjuvant and Concomitant Hormone Therapy to an Exclusive Curative Cornformational Radiotherapy of Locolized Prostate Cancer With Intermediate Prognosis
Study Start Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Impact of complete androgen blockade for 4 months
  2. Survival, in terms of clinical or biological remission, at 5 years
  3. Overall survival
  4. Acute and late toxicity
  5. Quality of life
  6. Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone)

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed prostate cancer, meeting the following clinical staging criteria:

    • Stage T1b-T1c AND prostate specific antigen (PSA) ≥ 10 ng/mL OR Stage T1b-T1c AND Gleason score ≥ 7 OR Stage T2a-T3a
    • No lymph node invasion (N0 or N-)

      • Patients with ≥ 10% risk by the Partin table must undergo curage
    • No metastatic disease (M0) by thoracic radiography and bone scan
  • PSA < 30 ng/mL
  • No history of invasive cancer



  • Under 75

Performance status

  • ECOG 0-1

Life expectancy

  • At least 10 years


  • Not specified


  • Not specified


  • Not specified


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • No prior hormonal therapy


  • No prior pelvic radiotherapy


  • No prior radical prostatectomy
  • No prior castration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00104741

Clinique De Rochebelle Recruiting
Ales, France, F-30100
Contact: Jacques Cretin    33-4-6654-2110      
Institut Sainte Catherine Recruiting
Avignon, France, 84082
Contact: Bruno Chauvet, MD    33-4-9027-6182      
Hopital Louis Pasteur Recruiting
Colmar, France, 68024
Contact: Contact Person    33-03-89-12-4102      
Hopitaux Civils de Colmar Recruiting
Colmar, France, 68024
Contact: Contact Person    33-3-8912-4000      
Centre Hospitalier Universitaire Henri Mondor Recruiting
Creteil, France, 94000
Contact: Jean-Leon Lagrange, MD    33-1-49-814-524   
Hopital Intercommunal De Creteil Recruiting
Creteil, France, 94010
Contact: Michel Martin, MD    33-1-45-17-52-10   
Hopital Jean Monnet Recruiting
Epinal, France, 88021
Contact: Michel Aubertel    33-3-2968-7020      
Centre Hospitalier Intercommunal des Alpes du Sud Recruiting
Gap, France, 05007
Contact: Abdellatif Zribi, MD    33-4-9240-6785      
Centre Oscar Lambret Recruiting
Lille, France, 59020
Contact: Eric Lartigau, MD, PhD    33-3-2029-5911   
Centre Hospital Regional Universitaire de Limoges Recruiting
Limoges, France, 87042
Contact: Pierre Clavere, MD    33-5-5505-6268   
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Pascal Pommier, MD    33-4-7878-2648   
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Recruiting
Marseille, France, 13273
Contact: Contact Person    33-91-22-37-00      
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Contact person    33-91-385-708      
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Jean-Bernard Dubois, MD    33-4-6761-3100      
Centre Hospitalier de Mulhouse Recruiting
Mulhouse, France, 68051
Contact: Contact Person    33-3-8964-7522      
Centre Hospitalier Recruiting
Mulhouse, France, 68070
Contact: Alain Grandgirard    33-3-8964-7522      
Centre Regional Rene Gauducheau Recruiting
Nantes, France, 44035
Contact: Sylvain Bourdin, MD    33-2-4067-9900      
Centre Antoine Lacassagne Recruiting
Nice, France, 06088
Contact: J. M. Hannoun-Levi, MD    33-4-9203-1260      
Clinique De Valdegour Recruiting
Nimes, France, 30900
Contact: Jacques Cretin, MD    33-46-662-58-02      
Hopital d'Instruction des Armees du Val de Grace Recruiting
Paris, France, 75005
Contact: Maryse Fayolle-Campana    33-1-4051-4558      
Hopital Saint-Louis Recruiting
Paris, France, 75475
Contact: Christophe Hennequin, PhD    33-1-4249-4949   
CHU Pitie-Salpetriere Recruiting
Paris, France, 75651
Contact: Jean-Marc Simon    33-142-178-174      
Hopital Tenon Recruiting
Paris, France, 75970
Contact: Francoise Pene, MD    33-1-5601-6562   
Centre Hospitalier Lyon Sud Recruiting
Pierre Benite, France, 69495
Contact: Contact Person    33-4-78-86-11-58      
CHU Poitiers Recruiting
Poitiers, France, 86021
Contact: Contact Person    33-549-444-538      
Institut Jean Godinot Recruiting
Reims, France, 51056
Contact: Tan Dat Nguyen, MD    33-03-2650-4351   
Centre Eugene Marquis Recruiting
Rennes, France, 35064
Contact: Elizabeth Le Prise, MD    33-2-9925-3000   
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Bernard M. Dubray, MD, PhD    33-232-082-262      
Institut Claudius Regaud Recruiting
Toulouse, France, 31052
Contact: Jean-Marc Bachaud, MD    33-5-6142-4242      
Centre Hospitalier Universitaire Bretonneau de Tours Recruiting
Tours, France, 37044
Contact: Olivier Le Floch, MD    33-2-4747-4776   
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Contact Person    33-3-8359-8400      
Sponsors and Collaborators
Study Chair: Bernard M. Dubray, MD, PhD Centre Henri Becquerel

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00104741     History of Changes
Other Study ID Numbers: CDR0000416088
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: April 2008

Keywords provided by National Cancer Institute (NCI):
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists