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.
18 Years
N/A
Male
Prostate Cancer
Trial Information
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.
OBJECTIVES:
Primary
- Compare the efficacy, in terms of event-free survival at 5 years, of immediate
radio-hormonal therapy immediately after prostatectomy for tumor pT2, R1, pN0, or pNx
versus radio-hormonal therapy at biochemical relapse.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the metastasis-free survival of these patients.
- Compare the acute and late toxicities of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the functional dependence of patients over 75 years old.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I (delayed treatment): Patients receive triptorelin intramuscularly on day 1 and
then 3 months later. Patients also undergo conformal radiotherapy daily, 5 days a week,
for 7 weeks. Treatment begins at biochemical relapse (PSA is more than 0.2 ng/mL) and
before PSA is more than 2 ng/mL.
- Arm II (immediate treatment): Patients receive treatment as in arm I, but treatment
begins within 6 months after surgery.
After completion of study treatment, patients are followed for up to 5 years.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event-free survival (clinical progression, biochemical progression, death) at 5 years
Safety Issue:
No
Principal Investigator
Pierre Richaud, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Institut Bergonié
Authority:
Unspecified
Study ID:
CDR0000577485
NCT ID:
NCT00667069
Start Date:
December 2007
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage III prostate cancer
- stage IV prostate cancer
- Prostatic Neoplasms
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