Radiation Therapy in Treating Patients With Stage I, 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: NCT00003607
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 23, 2016
Information provided by:

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: radiation therapy Phase 3

Detailed Description:


  • Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis.
  • Compare the toxic effects of these two regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Determine the prognostic factors of progression in these patients.
  • Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis).

Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive pelvic irradiation plus local prostate irradiation.
  • Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks.

Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter.

Patients are followed at 2 and 6 months and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate
Study Start Date : December 1997
Actual Primary Completion Date : December 2002
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically proven adenocarcinoma of the prostate

    • Stage I (T1b or T1c, N0, M0)
    • Stage II (T2, N0, M0)
    • Stage III (T3, N0, M0)
  • Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria:

    • Gleason score at least 7
    • Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN)
    • T3 OR
  • Good prognosis defined as meeting 1 of the following criteria:

    • T1b or T2
    • T1c with Gleason score less than 7 and PSA less than 3 times ULN
  • No metastases by bone scans or chest x-ray



  • 75 and under

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 10 years


  • Not specified


  • Not specified


  • Not specified


  • No other malignancy within the past 10 years except basal cell skin cancer
  • No adenopathies


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8 months
  • No concurrent luteinizing hormone-releasing hormone agonists
  • No concurrent anti-androgen therapy
  • No concurrent hormonal therapy in high-risk group


  • No prior pelvic radiotherapy


  • No prior lymphadenectomy
  • No prior surgical castration
  • No prior prostatectomy
  • At least 1 month since prior transurethral resection

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): NCT00003607

Centre Paul Papin
Angers, France, 49036
Centre Hospitalier d'Annecy
Annecy, France, 74011 Cedex
Institut Bergonie
Bordeaux, France, 33076
Centre Regional Francois Baclesse
Caen, France, 14076
Centre de Radiotherapie du Parc
Chalon Sur Saone, France, 71100
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94010
Centre Oscar Lambret
Lille, France, 59020
Centre Hospital Regional Universitaire de Limoges
Limoges, France, 87042
Clinique de la Sauvegarde - Clinique Jeanne D'Arc
Lyon, France, 69008
Clinique de la Sauvegarde
Lyon, France, 69008
Centre Leon Berard
Lyon, France, 69373
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
CHR D'Orleans - Hopital de la Source
Orleans, France, 45067
Hopital d'Instruction des Armees du Val de Grace
Paris, France
Centre Hospitalier Lyon Sud
Pierre Benite, France, 69495
Institut Jean Godinot
Reims, France, 51056
Centre Eugene Marquis
Rennes, France, 35064
CHG Roanne
Roanne, France, F-42300
Clinique de l'Orangerie
Strasbourg, France, 67010
Centre Paul Strauss
Strasbourg, France, 67085
Institut Claudius Regaud
Toulouse, France, 31052
Centre Marie Curie
Valance, France, 26000
Sponsors and Collaborators
Study Chair: Pascal Pommier, MD Centre Leon Berard

Publications of Results:
Pommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005. Identifier: NCT00003607     History of Changes
Other Study ID Numbers: CDR0000066684
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016

Keywords provided by UNICANCER:
adenocarcinoma of the prostate
stage I prostate cancer
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