Medical and Economic Evaluation for Intermediate-risk Prostate Cancer

Last updated: September 12, 2016
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Urologic Cancer

Prostate Cancer

Treatment

N/A

Clinical Study ID

NCT02271659
2011-704
  • Ages 18-80
  • Male

Study Summary

The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.

The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age between 18 and 80 years;

  • life expectancy of greater than 10 years;

  • prostate adenocarcinoma histologically proven;

  • prostate cancer has to be of intermediate-risk based on at least one of the threefollowing criteria: PSA between 10 ng/ml and 20 ng/ml, and/or a Gleason score of 7and/or a T2B. Karnofsky performance status ≥ 60% and consequently performance statusECOG 0-2.

  • the patient has to be the beneficiary of the social security system (order n° 2006-477from April 26th 2006);

  • the signed consent form.

Exclusion

Exclusion Criteria:

  • PSA level > 20;

  • Gleason > 7;

  • clinical T3A or T3B or MRI (a simple suspicion/ doubt on the MRI regarding the T3Awon't be an exclusion criterion);

  • prostate volume > 60 cc;

  • pelvic lymph nodes involvement at dissection or imaging (ADP > 1.5 cm);

  • concurrent hormone therapy;

  • the presence of distant metastasis (M1);

  • history of abdominal or pelvic irradiation;

  • history of prostate resection in the previous 6 months and/or not allowing theimplantation of markers;

  • history of uncontrolled cancer and/or treated since less than 5 years (excepting thebasal-cell carcinoma);

  • urinary discomfort with an IPSS (International Prostate Symptom Score) > 15 (withoutalpha-blocking);

  • inflammatory bowel disorder such as ulcerative colitis or the Crohn's disease;

  • other undergoing study that may interfere with the present study;

  • patient under legal protection measure.

Study Design

Total Participants: 298
Study Start date:
June 01, 2013
Estimated Completion Date:
June 30, 2021

Connect with a study center

  • Clinique Claude Bernard

    Albi, 81000
    France

    Active - Recruiting

  • CHU Jean MINJOZ

    Besançon, 25030
    France

    Site Not Available

  • Clinique Tivoli

    Bordeaux, 33000
    France

    Active - Recruiting

  • Institut Bergonie

    Bordeaux, 33076
    France

    Active - Recruiting

  • CHRU Morvan

    Brest, 29609
    France

    Active - Recruiting

  • Centre Francois Baclesse

    Caen, 14076
    France

    Site Not Available

  • Centre Georges François Leclerc

    Dijon, 21079
    France

    Active - Recruiting

  • Hopital de la Tronche

    Grenoble, 38043
    France

    Active - Recruiting

  • Centre Regional de Lutte Contre Le Cancer Rhone-Alpes Centre Leon Berard

    Lyon, 69373
    France

    Active - Recruiting

  • Centre d'oncologie et de radiothérapie Mâcon

    Macon, 71031
    France

    Site Not Available

  • Institut Paoli Calmette

    Marseille, 13273
    France

    Active - Recruiting

  • Centre Val D'Aurelle

    Montpellier, 34298
    France

    Active - Recruiting

  • Institut de Cancerologie de Lorraine Alexis Vautrin

    Nancy, 54519
    France

    Active - Recruiting

  • Clinique Hartmann

    Neuilly Sur Seine, 92200
    France

    Site Not Available

  • Centre Antoine Lacassagne

    Nice, 06189
    France

    Site Not Available

  • Hopital George Pompidou

    Paris, 75908
    France

    Site Not Available

  • Hopital Saint-Louis

    Paris, 75475
    France

    Active - Recruiting

  • Institut Curie

    Paris, 75248
    France

    Active - Recruiting

  • Hospices Civils de Lyon

    Pierre-Bénite, 69495
    France

    Active - Recruiting

  • CHU Poitiers

    Poitiers, 86021
    France

    Active - Recruiting

  • Institut Jean Godinot,

    Reims, 51056
    France

    Site Not Available

  • Polyclinique Courlancy

    Reims, 51057
    France

    Active - Recruiting

  • Centre Eugène Marquis

    Rennes, 50420
    France

    Active - Recruiting

  • Centre Henry Becquerel

    Rouen, 76038
    France

    Site Not Available

  • Institut Cancérologique de la Loire

    Saint-priest En Jarez, 42270
    France

    Active - Recruiting

  • Centre Paul Strauss

    Strasbourg, 67065
    France

    Active - Recruiting

  • Institut Claudius Regaud

    Toulouse, 31052
    France

    Active - Recruiting

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Active - Recruiting

  • Clinique du TONKIN

    Villeurbanne, 69626
    France

    Site Not Available

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