Clinical trial NCT01994239: Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy
Official title: A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Adenocarcinoma of Prostate
Keywords: Prostate-Specific Antigen
LHRH antagonist
Radiotherapy
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2013-11-25
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy.

122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme:

* Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy
* Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months

Eligibility criteria: 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 outcomes:
measure: The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Survival without biological event
timeFrame: 5 years
measure: Survival without clinical event
timeFrame: 5 years
measure: Survival without metastases
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Acute and late toxicities of the association of hormone therapy with radiotherapy
timeFrame: up to 5 years
measure: Toxicities of radiotherapy
timeFrame: up to 5 years
measure: Patient Quality of life
timeFrame: up to 5 years after the end of the radiotherapy
measure: kinetics of testosterone
timeFrame: up to 12 months after the end of the radiotherapy and after biological release
Other outcomes:
Locations:
city: Angers
country: France
facility: Institut de Cancérologie de l'Ouest -Site Paul Papin
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besançon
country: France
facility: Chu Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: Centre d'oncologie - Clinique Pasteur
city: Caen
country: France
facility: Centre François Baclesse
city: Chambéry
country: France
facility: Centre hospitalier de Chambéry
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: Centre d'oncologie et de radiothérapie du Parc
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Hyeres
country: France
facility: Clinique Sainte-Marguerite
city: La Roche-sur-Yon
country: France
facility: Chd Vendee
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: Clinique Clairval
city: Marseille
country: France
facility: CHU La Timone - Hôpital Nord
city: Montauban
country: France
facility: Groupe Oncorad Garonne Clinique Du Pont de Chaume
city: Montfermeil
country: France
facility: Ghi Le Raincy / Montfermeil
city: Mougins
country: France
facility: Centre Azureen de Cancerologie
city: Mulhouse
country: France
facility: Centre Hospitalier Emile Muller
city: Nancy
country: France
facility: Institut de Cancerologie de Lorraine
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nîmes
country: France
facility: Chu Caremeau
city: Orléans
country: France
facility: CHR Orléans La Source
city: Paris
country: France
facility: Hôpital d'Instruction des Armées du Val de Grâce
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU de POITIERS
city: Reims
country: France
facility: Institut Jean Godinot
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Gregoire
country: France
facility: CHP Saint Grégoire
city: Saint Malo
country: France
facility: Clinique Cote Emeraude
city: Saint-Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest René Gauducheau
city: Saint-Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie LUCIEN NEUWIRTH
city: Thonon-les-Bains
country: France
facility: Hôpitaux du Léman
city: Toulouse
country: France
facility: Groupe Oncorad Garonne
city: Valence
country: France
facility: Centre Marie Curie
city: Villejuif
country: France
facility: GUSTAVE ROUSSY, Cancer Campus, Grand Paris
Study officials:
affiliation: Clinique Pasteur
name: Igor LATORZEFF
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Henri Mondor
name: Laurent SALOMON
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Bergonié
name: Paul SARGOS
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre François Baclesse
name: Emmanuel MEYER
role: PRINCIPAL_INVESTIGATOR
References: