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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 recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00104741
First received: March 3, 2005
Last updated: February 18, 2011
Last verified: April 2008
History of Changes
  Purpose

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 Intervention Phase
Prostate Cancer
 Drug: flutamide
Drug: triptorelin
Procedure: neoadjuvant therapy
Radiation: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Impact of complete androgen blockade for 4 months [ Designated as safety issue: No ]
  • Survival, in terms of clinical or biological remission, at 5 years [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Acute and late toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]
  • Value and time-delay to obtain prostate-specific antigen nadir (for patients undergoing external beam radiotherapy alone) [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: July 2004
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   up to 74 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Under 75

Performance status

  • ECOG 0-1

Life expectancy

  • At least 10 years

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • No prior hormonal therapy

Radiotherapy

  • No prior pelvic radiotherapy

Surgery

  • No prior radical prostatectomy
  • No prior castration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104741

Locations
France
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        
Hopitaux Civils de Colmar Recruiting
Colmar, France, 68024
Contact: Contact Person     33-3-8912-4000        
Hopital Louis Pasteur Recruiting
Colmar, France, 68024
Contact: Contact Person     33-03-89-12-4102        
Hopital Intercommunal De Creteil Recruiting
Creteil, France, 94010
Contact: Michel Martin, MD     33-1-45-17-52-10     michel.martin@chicreteil.fr    
Centre Hospitalier Universitaire Henri Mondor Recruiting
Creteil, France, 94000
Contact: Jean-Leon Lagrange, MD     33-1-49-814-524     jean-leon.lagrange@hmn.aphp.fr    
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     e-lartigau@o-lambret.fr    
Centre Hospital Regional Universitaire de Limoges Recruiting
Limoges, France, 87042
Contact: Pierre Clavere, MD     33-5-5505-6268     pierre.clavere@chu-limoges.fr    
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Pascal Pommier, MD     33-4-7878-2648     pommier@lyon.fnclcc.fr    
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Contact person     33-91-385-708        
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes Recruiting
Marseille, France, 13273
Contact: Contact Person     33-91-22-37-00        
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 Saint-Louis Recruiting
Paris, France, 75475
Contact: Christophe Hennequin, PhD     33-1-4249-4949     christophe.hennequin@sls.ap-hop-paris.fr    
Hopital Tenon Recruiting
Paris, France, 75970
Contact: Francoise Pene, MD     33-1-5601-6562     francoisepene@tnn.aphp.paris.fr    
Hopital d'Instruction des Armees du Val de Grace Recruiting
Paris, France, 75005
Contact: Maryse Fayolle-Campana     33-1-4051-4558        
CHU Pitie-Salpetriere Recruiting
Paris, France, 75651
Contact: Jean-Marc Simon     33-142-178-174        
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     tandat.nguyen@reims.fnclcc.fr    
Centre Eugene Marquis Recruiting
Rennes, France, 35064
Contact: Elizabeth Le Prise, MD     33-2-9925-3000     elptrennes@fnclcc.fr    
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     lefloch@med.univ-tours.fr    
Centre Alexis Vautrin Recruiting
Vandoeuvre-les-Nancy, France, 54511
Contact: Contact Person     33-3-8359-8400        
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Bernard M. Dubray, MD, PhD Centre Henri Becquerel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00104741     History of Changes
Other Study ID Numbers: CDR0000416088, FRE-FNCLCC-GETUG-14/0207, EU-20503
Study First Received: March 3, 2005
Last Updated: February 18, 2011
Health Authority: Unspecified

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Flutamide
Triptorelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 21, 2013