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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00667069

Sponsor: UNICANCER

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum 120 Years
  • 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

View trial on ClinicalTrials.gov