Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

June 22, 2016 updated by: UNICANCER

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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

Enrollment (Anticipated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • More than 10 years

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

  • No prior pelvic radiotherapy

Surgery:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Pascal Pommier, MD, Centre Leon Bérard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1997

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 23, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066684
  • FRE-FNCLCC-GETUG-01
  • EU-98029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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