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

February 19, 2021 updated by: UNICANCER

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

378

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

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

1 second to 74 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: radiotherapy alone
Radiation: radiation therapy
Experimental: Radiotherapy + androgene deprivation
Radiation: radiation therapy
Drug: flutamide
Drug: triptorelin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

UNICANCER

Investigators

  • Study Chair: Bernard M. Dubray, MD, PhD, Centre Henri Becquerel

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 (Actual)

September 10, 2003

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 15, 2015

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 19, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-0160/0207
  • FRE-FNCLCC-GETUG-14/0207
  • EU-20503

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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