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Clinical Trials in France / NCT00967863
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Radiation Therapy in Treating Patients Receiving Hormone Therapy for Prostate Cancer (GETUG-AFU 18)

NCT00967863 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2008-10
Last updated
2026-07-31

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

3-dimensional conformal radiation therapyintensity-modulated radiation therapy

3-dimensional conformal radiation therapy: Patients undergo radiotherapy

intensity-modulated radiation therapy: Patients undergo radiotherapy

Study 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 less damage to normal tissue. It is not yet known which dose of radiation therapy is more effective in treating patients with prostate cancer.

PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens in treating patients with prostate cancer receiving hormone therapy.

Eligibility

Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Institut de Cancérologie de l'Ouest Paul Papin Angers France
Institut Bergonie Bordeaux France
Centre Francois Baclesse Caen France
Centre hospitalier Métropole Savoie Chambéry France
Clinique Léonard de Vinci Chambray-lès-Tours France
CHU Henri Mondor Créteil France
Centre Léon Bérard Lyon France
Hopital La Timone Marseille France
Centre de Cancérologie du Grand Montpellier Montpellier France
Centre Val D'Aurelle Montpellier France
Centre Azureen de Cancerologie Mougins France
Chr Orleans Orléans France
Hôpital Saint Louis Paris France
Centre Hospitalier Lyon Sud Pierre-Bénite France
Centre CARIO - HPCA Plérin France
Hôpital Jean Bernard - CHU de Poitiers Poitiers France
Centre Eugène Marquis Rennes France
Centre Henri Becquerel Rouen France
Centre Rene Gauducheau Saint-Herblain France
Hia Begin Saint-Mandé France
Institut de Cancérologie LUCIEN NEUWIRTH Saint-Priest-en-Jarez France
Centre Paul Strauss Strasbourg France
Clinique PASTEUR Toulouse France
Ch Bretonneau Tours France
Centre Alexis Vautrin Vandœuvre-lès-Nancy France

More UNICANCER trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00967863 on ClinicalTrials.gov ↗ ← All trials in France