Status:
COMPLETED
Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer
Lead Sponsor:
UNICANCER
Collaborating Sponsors:
Ipsen
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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-...
Detailed Description
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 radi...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate
- pT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV)
- PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month)
- May receive treatment within 6 months after surgery
- Positive margins (tumoral glands in contact with contour ink) on the surgical specimen
- pN0 or pNx (lymph nodes resected during negative prostatectomy or lymph nodes not resected)
- No current clinical or biochemical progressive disease
- Life expectancy ≥10 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Patient must be affiliated to the social security system
- Patient must have received the information sheet and signed the consent form
- Exclusion criteria:
- Patient with prostate cancer other than adenocarcinoma
- Gleason score ≥8 and with seminal vesicles involved
- pN1 disease (Histologically confirmed nodal invasion during initial lymph node resection)
- pT2 disease
- Prior surgical or chemical castration
- Prior hormonal therapy
- Prior radiotherapy within 3 months after radical prostatectomy
- Prior pelvic radiotherapy
- No history of cancer (except basal cell skin cancer) within 5 years of surgery
- No known severe hypertension uncontrolled by appropriate therapy (≥160 mm Hg systolic and/or ≥90 mm Hg diastolic)
- Known hypersensitivity to gonadotropin-releasing hormone or its analogs
- Contraindication to intramuscular injection
- Concurrent participation in another interventional study
- Patients under protective custody or guardianship, unable to comply with the specific requirements of the study or unable to understand the purpose of the study
Exclusion
Key Trial Info
Start Date :
April 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2022
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT00667069
Start Date
April 7 2008
End Date
May 24 2022
Last Update
June 5 2025
Active Locations (17)
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1
Hopital Saint Andre
Bordeaux, France, 33075
2
Institut Bergonie
Bordeaux, France, 33076
3
Centre Regional Francois Baclesse
Caen, France, 14076
4
Hopitaux Civils de Colmar
Colmar, France, 68024