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Status:

COMPLETED

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

Lead Sponsor:

UNICANCER

Conditions:

Prostate Cancer

Eligibility:

MALE

Up to 74 years

Phase:

PHASE3

Brief Summary

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-ra...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 10 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 15 2015

    Estimated Enrollment :

    378 Patients enrolled

    Trial Details

    Trial ID

    NCT00104741

    Start Date

    September 10 2003

    End Date

    October 15 2015

    Last Update

    February 21 2021

    Active Locations (31)

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    Page 1 of 8 (31 locations)

    1

    Clinique De Rochebelle

    Alès, France, F-30100

    2

    Institut Sainte Catherine

    Avignon, France, 84082

    3

    Hopital Louis Pasteur

    Colmar, France, 68024

    4

    Hopitaux Civils de Colmar

    Colmar, France, 68024