Status:
ACTIVE_NOT_RECRUITING
Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)
Lead Sponsor:
UNICANCER
Conditions:
Prostate Cancer
Eligibility:
MALE
18-80 years
Phase:
NA
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause...
Detailed Description
OBJECTIVES: Primary * Assess the impact of increasing the radiation dose 10 Gy on biochemical or clinical progression-free survival at 5 years in patients with unfavorable-risk prostate cancer recei...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- Unfavorable disease, defined by at least 1 of the following criteria:
- Clinical stage T3 or T4
- Gleason score ≥8
- Serum prostate-specific antigen (PSA) ≥20 ng/mL and ≤100 ng/mL
- pN0 disease allowed if lymphadenectomy performed before patient began hormone therapy
- No pelvic lymph nodes ≥15 mm by CT scan or MRI
- No axillary lymph node involvement (pN1)
- No bone metastasis
- Must be starting hormonal treatment on or up to 6 months before beginning radiotherapy
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy \>5 years
- Must be enrolled in a social security program
- No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
- No severe uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg)
- No contraindication to luteinizing hormone-releasing hormone agonists
- No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
- No hip prosthesis
- Must not be deprived of liberty or under guardianship
- No geographical, social, or psychological reasons that would preclude follow up
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic irradiation
- At least 3-4 months since prior transurethral resection
- No other prior surgery for prostate cancer
- No concurrent participation in another clinical trial which would require approval upon entry to this trial
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00967863
Start Date
October 1 2008
End Date
October 1 2026
Last Update
December 18 2024
Active Locations (25)
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1
Institut de Cancérologie de l'Ouest Paul Papin
Angers, France, 49933
2
Institut Bergonie
Bordeaux, France, 33076
3
Centre Francois Baclesse
Caen, France, 14076
4
Centre hospitalier Métropole Savoie
Chambéry, France, 73011