Ireland
--:--IST
Active, not recruiting Phase 2

Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy

NCT01994239 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Phase 2
Started
2012-12
Last updated
2024-12-16

Condition(s) studied

Adenocarcinoma of Prostate

Investigational drug(s) / intervention(s)

Degarelix →Pelvic Radiotherapy

Degarelix: First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)

Pelvic Radiotherapy: 46 Gy in 23 fractions Prostate only-boost up to 66 Gy

Study summary

The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage) 2. R0 or R1 3. pN0 or pNx 4. Post prostatectomy PSA ≥0.2 ng/mL measured between 1 month and 4 months after surgery and increasing to a second test performed between 1 et 8 months after the post prostatectomy dosage 5. PSA ≤2 ng/mL at moment of the randomisation 6. No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0 7. Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³ 8. Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN 9. Creatinine \<140 µmol/L (or clearance \>60 mL/min) 10. Normal fasting glucose 11. Eastern Cooperative Oncology Group (ECOG) ≤1 12. Age \>18 years 13. Life expectancy ≥10 years 14. Patients with invasive cancer in complete response for more than five years are eligible 15. Patients who have received the information sheet and signed the informed consent form 16. Patients with a public or a private health insurance coverage Exclusion Criteria: 1. Prostate cancer histology other than adenocarcinoma 2. Patients pN1, N1 and M1 3. History of pelvic radiotherapy 4. Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.) 5. Testosterone ≤0.5 ng/mL 6. History of surgical castration 7. Previous treatment by hormonotherapy 8. Antineoplastic treatment in progress 9. History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated) 10. Known pituitary adenoma 11. Severe hypertension uncontrolled by appropriate treatment (160 mm Hg systolic and/or 90 mm Hg diastolic) 12. Patient with a corrected QT interval (using Fridericia correction) greater than 450 msec 13. Individual deprived of liberty or placed under the authority of a tutor 14. Unable to undergo medical monitoring test for geographical, social or psychological reasons 15. Known hypersensitivity to the treatment in test 16. Administration of an investigational therapeutic within 28 days prior to the screening visit or more if treatment is likely to influence the outcome of this

Primary outcome measure(s)

  • The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival — 5 years

Trial sites (39)

FacilityCityRegionStatus
Institut de Cancérologie de l'Ouest -Site Paul Papin Angers France
Institut Sainte Catherine Avignon France
Chu Jean Minjoz Besançon France
Institut Bergonié Bordeaux France
Centre d'oncologie - Clinique Pasteur Brest France
Centre François Baclesse Caen France
Centre hospitalier de Chambéry Chambéry France
Hôpital Henri Mondor Créteil France
Centre d'oncologie et de radiothérapie du Parc Dijon France
Centre Georges François Leclerc Dijon France
Clinique Sainte-Marguerite Hyères France
Chd Vendee La Roche-sur-Yon France
Centre Leon Berard Lyon France
Clinique Clairval Marseille France
CHU La Timone - Hôpital Nord Marseille France
Groupe Oncorad Garonne Clinique Du Pont de Chaume Montauban France
Ghi Le Raincy / Montfermeil Montfermeil France
Centre Azureen de Cancerologie Mougins France
Centre Hospitalier Emile Muller Mulhouse France
Institut de Cancerologie de Lorraine Nancy France
Centre Antoine Lacassagne Nice France
Chu Caremeau Nîmes France
CHR Orléans La Source Orléans France
Hôpital d'Instruction des Armées du Val de Grâce Paris France
Hôpital Saint Louis Paris France
Centre Hospitalier Lyon Sud Pierre-Bénite France
CHU de POITIERS Poitiers France
Institut Jean Godinot Reims France
Centre Henri Becquerel Rouen France
Clinique Armoricaine de Radiologie Saint-Brieuc France
CHP Saint Grégoire Saint-Grégoire France
Institut de Cancérologie de l'Ouest René Gauducheau Saint-Herblain France
Clinique Mutualiste de l'Estuaire Saint-Nazaire France
Institut de Cancérologie LUCIEN NEUWIRTH Saint-Priest-en-Jarez France
Clinique Cote Emeraude St-Malo France
Hôpitaux du Léman Thonon-les-Bains France
Groupe Oncorad Garonne Toulouse France
Centre Marie Curie Valence France
GUSTAVE ROUSSY, Cancer Campus, Grand Paris Villejuif France
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 NCT01994239 on ClinicalTrials.gov ↗ ← All trials in France