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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. The completion date has passed and the status has not been verified in more than two years.
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
  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:


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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104741

Locations
France
Clinique De Rochebelle
Ales, France, F-30100
Institut Sainte Catherine
Avignon, France, 84082
Hopital Louis Pasteur
Colmar, France, 68024
Hopitaux Civils de Colmar
Colmar, France, 68024
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94000
Hopital Intercommunal De Creteil
Creteil, France, 94010
Hopital Jean Monnet
Epinal, France, 88021
Centre Hospitalier Intercommunal des Alpes du Sud
Gap, France, 05007
Centre Oscar Lambret
Lille, France, 59020
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Centre Leon Berard
Lyon, France, 69373
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
CHU de la Timone
Marseille, France, 13385
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Centre Hospitalier de Mulhouse
Mulhouse, France, 68051
Centre Hospitalier
Mulhouse, France, 68070
Centre Regional Rene Gauducheau
Nantes, France, 44035
Centre Antoine Lacassagne
Nice, France, 06088
Clinique De Valdegour
Nimes, France, 30900
Hopital d'Instruction des Armees du Val de Grace
Paris, France, 75005
Hopital Saint-Louis
Paris, France, 75475
CHU Pitie-Salpetriere
Paris, France, 75651
Hopital Tenon
Paris, France, 75970
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
CHU Poitiers
Poitiers, France, 86021
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35064
Centre Henri Becquerel
Rouen, France, 76000
Institut Claudius Regaud
Toulouse, France, 31052
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, France, 37044
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Bernard M. Dubray, MD, PhD Centre Henri Becquerel
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Triptorelin Pamoate
Flutamide
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

ClinicalTrials.gov processed this record on December 05, 2016