Randomized, Multicenter Study Comparing the Immediate Adjuvant Radiotherapy Associate With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) vs Delayed Radiotherapy Until Biochemical Relapse Associated With Hormonal Therapy of LH-RH Analogue (Decapeptyl® LP) in Patients With Operable Prostate Cancer pT3 R1 pN0 or pNx at Intermediate Risk.


Condition: Prostate Cancer

Intervention:

  • Drug: triptorelin
  • Procedure: adjuvant therapy
  • Radiation: 3-dimensional conformal radiation therapy

Purpose: RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether giving triptorelin and radiation therapy soon after surgery or later after surgery is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is studying giving triptorelin and radiation therapy soon after surgery to see how well it works compared with giving them later after surgery in treating patients who have undergone surgery for intermediate-risk stage III or stage IV prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00667069

Sponsor: UNICANCER

Primary Outcome Measures:

  • Measure: Event-free survival (clinical progression, biochemical progression, death) at 5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Overall survival
  • Safety Issue:
  • Measure: Metastases-free survival
  • Safety Issue:
  • Measure: Acute or chronic toxicity
  • Safety Issue:
  • Measure: Quality of life
  • Safety Issue:
  • Measure: Functional dependence in patients over 75 years old
  • Safety Issue:

Estimated Enrollment: 718

Study Start Date: December 2007

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Disease Characteristics:

  • Histologically confirmed adenocarcinoma of the prostate
  • pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
  • Localized disease
  • pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
  • No histologically confirmed nodal involvement during initial surgery (pN1 disease)
  • No pT2 disease
  • No tumors of other histology than adenocarcinoma
  • Must have undergone curative surgery in the past 6 months
  • Positive margins (tumoral glands in contact with contour ink)
  • No current clinical or biochemical disease
  • PSA ≤ 0.1 ng/mL after prostatectomy (confirmed at 1 month)
  • Gleason score < 8 with no seminal vesicles involved

Patient Characteristics:

  • ECOG performance status 0 or 1
  • Life expectancy ≥ 10 years
  • Affiliated with social security program
  • No history of cancer within 5 years of surgery except basal cell skin cancer
  • No known severe hypertension uncontrolled by appropriate therapy (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic)
  • No known hypersensitivity to gonadotropin-releasing hormone or its analogs
  • No contraindication of intramuscular injection
  • No patients who are deprived of liberty or under guardianship
  • Not unable to undergo medical monitoring due to geographical, social, or psychological reasons

Prior Concurrent Therapy:

  • No prior surgical or chemical castration
  • No prior hormonal therapy
  • No prior radiotherapy within 3 months after radical prostatectomy
  • No prior pelvic radiotherapy
  • No concurrent participation in another study

Locations:

  • Hopital Saint Andre
  • Bordeaux 33075 France
  • Institut Bergonie
  • Bordeaux 33076 France
  • Centre Regional Francois Baclesse
  • Caen 14076 France
  • Hopitaux Civils de Colmar
  • Colmar 68024 France
  • Centre Hospitalier Universitaire Henri Mondor
  • Creteil 94000 France
  • Centre Leon Berard
  • Lyon 69373 France
  • Clinique du Pont de Chaume
  • Montauban 82017 France
  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
  • Montpellier 34298 France
  • Centre Regional Rene Gauducheau
  • Nantes-Saint Herblain 44805 France
  • Hopital Europeen Georges Pompidou
  • Paris 75015 France
  • Centre Hospitalier Lyon Sud
  • Pierre Benite 69495 France
  • CHU Poitiers
  • Poitiers 86021 France
  • Centre Henri Becquerel
  • Rouen 76038 France
  • Institut de Cancerologie de la Loire
  • Saint Priest en Jarez 42270 France
  • Institut Claudius Regaud
  • Toulouse 31052 France
  • Centre Alexis Vautrin
  • Vandoeuvre-les-Nancy 54511 France
  • Institut Gustave Roussy
  • Villejuif F-94805 France

View trial on ClinicalTrials.gov