Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Cette étude a pour but principal d'évaluer l'efficacité de l’abiraterone acetate et prednisone chez des patients atteints d’un cancer de la prostate métastatique hormono-naïf traités par déprivation androgénique en association avec le docetaxel, (avec ou sans radiothérapie locale) en terme de survie globale (OS) et la survie sans progression radiologique (rPFS).
Malattie studiate(Fonte di dati: BASEC)
Cancer de la prostate métastatique hormono-naïf
Health conditions
(Fonte di dati: WHO)
Metastatic Prostate Cancer
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
- Le premier groupe ou bras A, recevra une hormonothérapie avec ou sans chimiothérapie (docétaxel)
- Le second groupe ou bras B, recevra une hormonothérapie avec ou sans chimiothérapie (docétaxel) et de l’abiratérone
- Le troisième groupe ou bras C, recevra une hormonothérapie avec ou sans chimiothérapie (docétaxel) en association à un traitement par radiothérapie
- Le quatrième groupe ou bras D, recevra une hormonothérapie avec ou sans chimiothérapie (docétaxel) et de l’abiratérone en association à un traitement par radiothérapie.
Interventions
(Fonte di dati: WHO)
Drug: abiraterone acetate;Radiation: radiotherapy;Other: Androgen Deprivation Therapy;Drug: Docetaxel
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
Critère 1- Adénocarcinome de la prostate confirmé par histologie ou cytologie;
Critère 2- Maladie métastatique confirmée;
Critère 7- Biochimie : fonction rénale, potassium sérique et fonction hépatique adéquats
Criteri di esclusione
(Fonte di dati: BASEC)
Critère 1- Traitement local définitif antérieur du cancer de prostate;
Critère 7- Les patients présentant des antécédents d'hypertension non contrôlée par un traitement antihypertenseur qui n’a pas été modifié dans les 3 derniers mois avant randomisation;
Critère 8- Les patients présentant une insuffisance hépatique sévère ou modérée ne sont pas éligibles
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: Male
Maximum age: N/A
Minimum age: 18 Years
Inclusion criteria:
1. Histologically or cytologically confirmed adenocarcinoma of the prostate,
2. Metastatic disease documented by a positive bone scan (any technique) or CT scan or an
MRI. For patients with nodal metastases only, only patients with extra-pelvic enlarged
lymph nodes (lymph nodes located above the iliac bifurcation) can be included if they
have either:
o At least one extra-pelvic lymph node = 2 cm or extra-pelvic lymph node (s) = 1 cm if
the patients also have at least one pelvic lymph node = 2 cm
3. Patients with ECOG = 1 (patient with PS 2 due to bone pain can be accrued in the
trial),
4. Life expectancy of at least 6 months,
5. Male aged = 18 years old and = 80 years old ,
6. Hematology values:
- Hemoglobin = 10.0 g/dL,
- Platelet count = 100,000/mL,
- Neutrophil = 1500 cells/mm?
7. Biochemistry values:
- Renal function: Serum creatinine < 1.5 x ULN or a calculated creatinine clearance
= 60 mL/min,
- Serum potassium = 4 mmol/L,
- Liver function:
- Serum bilirubin = 1.5 x ULN (except for patients with documented Gilbert's
disease),
- AST and ALT = 1.5 x ULN (and = 5 ULN in case of liver metastases),
- ALK-P = 2.5 x ULN (in case of bone metastasis, ALK-P<1000U/L if bilirubin is
normal)
8. Patients must have received ADT for a maximum of 3 months before randomization and
there must be a minimum of 6 weeks between the start of ADT and the start of
Docetaxel,
9. Patients willing and clinically fit to receive Docetaxel which is defined by the
following :
- Patients respecting all inclusion and exclusion criteria And
- Patients with no contraindication to docetaxel according to the SmPC of the drug
And
- Patients presenting all medical requirements to receive docetaxel according to
the investigator's opinion.
10. Patients might have received previous radiation therapy directed to bone lesions,
11. Patients able to take oral medication,
12. Patients who have received the information sheet and signed the informed consent form,
13. Male patients who will receive Docetaxel and/or Abiraterone acetate and have partners
of childbearing potential and/or pregnant partners must use a method of birth control
in addition to an adequate barrier protection (condoms) as determined to be acceptable
by the study doctor during the treatment period and for 4 weeks after the last dose of
abiraterone acetate and/or for 6 months after the last dose of Docetaxel
14. Patients must be willing and able to comply with scheduled visits, treatment plan,
laboratory tests and other study procedures,
15. Patients with a public or a private health insurance coverage, according to local laws
for participation in clinical trials.
Exclusion Criteria:
1. Patients with previous definitive local treatment directed to the prostate primary
cancer (radiotherapy, brachytherapy, radical prostatectomy, ultrasound, cryotherapy,
or other). A previous trans-urethral resection of the prostate (TURP) and previous
local treatments of metastases are allowed,
2. Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate
cancer,
3. Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg
prednisone/prednisolone twice daily,
4. Active infection or other medical condition for which prednisone/prednisolone
(corticosteroid) use would be contra-indicated,
5. Previously treated with ketoconazole for prostate cancer for more than 7 days,
6. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4
weeks of randomization,
7. Hypertension not controlled by an anti-hypertensive treatment (systolic BP = 160 mmHg
or diastolic BP = 95 mmHg; 3 consecutive measures taken 5 minutes apart),
8. Severe or moderate hepatic impairment (Child - Pugh class C or B)
9. Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's
disease),
10. History of pituitary or adrenal dysfunction,
11. Clinically known significant heart disease in the past 6 months as evidenced by
myocardial infarction, or arterial thrombotic events, severe or unstable angina, or
New York Heart association (NYHA) Class II-IV heart disease or cardiac ejection
fraction measurement of < 50% at baseline,
12. Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
13. Patient with unstable pulmonary disease (eg. Pulmonary embolism)
14. Pathological finding consistent with small cell carcinoma of the prostate,
15. History of malignancy, except non-melanoma skin cancer, with a = 30% probability of
recurrence within 24 months,
16. Known allergies, hypersensitivity or intolerance to the study drugs or excipients or
docetaxel
17. Administration of an investigational therapeutic within 30 days of randomization,
18. Patients already included in another therapeutic trial involving an experimental drug
(patient in a non-experimental trial with no modification of the patient's care can be
included),
19. Patients with significantly altered mental status prohibiting the understanding of the
study or with psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule or any
condition which, in the opinion of the investigator, would preclude participation in
this trial. Those conditions should be discussed with the patient before registration
in the trial,
20. Individual deprived of liberty or placed under the authority of a tutor.
21. Patients with impaired vision should undergo a prompt and complete ophthalmologic
examination.
Patients with Cystoid Macular Oedema cannot be included due to a potential risk of
deterioration associated with docetaxel.
22. Concomitant use of strong CYP3A4 inhibitors (clarithromycin, indinavir, nefazodone,
nelfinavir, ritonavir, saquinavir, telithromycin.)
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Active, not recruiting
Titolo scientifico
(Fonte di dati: WHO)
A Prospective Randomised Phase III Study Of Androgen Deprivation Therapy With Or Without Docetaxel With Or Without Local Radiotherapy With Or Without Abiraterone Acetate And Prednisone In Patients With Metastatic Hormone-Na?ve Prostate Cancer
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 3
Punti finali primari
(Fonte di dati: WHO)
Survival
Punti finali secondari
(Fonte di dati: WHO)
Castration resistance-free survival (CRFS);Serious Genitourinary event-free survival (S-GU-EFS);Prostate cancer specific survival;Time to next skeletal-related event;PSA response rate;Prospective correlative study of PSA response/progression at 8 months after initation of ADT;Time to pain progression;Time to chemotherapy for CRPC;Quality of life questionnaire - Core 30 (QLQ-C30);Functional Assessment of Cancer Therapy - Prostate (FACT-P);Toxicity (with a specific focus on the use of long-term low-dose steroids);Changes in bone mineral density;Correlation of biomarkers with outcome
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Ginevra, Losanna
Paesi di esecuzione
(Fonte di dati: WHO)
Belgium, France, Germany, Ireland, Italy, Portugal, Romania, Spain, Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Dominik Rudolph Berthold
+41 79 556 78 92
dominik.berthold@chuv.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Karim FIZAZI, Professor;Alberto BOSSI, Doctor
Gustave Roussy, Cancer Campus Grand Paris - Paris
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Karim FIZAZI, Professor;Alberto BOSSI, Doctor
Gustave Roussy, Cancer Campus Grand Paris - Paris
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Data di autorizzazione da parte della commissione d’etica
18.05.2016
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2016-00277
Secondary ID (Fonte di dati: WHO)
UC-0160/1105 GETUG AFU-21
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