Zusammenfassende Beschreibung der Studie (Datenquelle: 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).
Untersuchte Krankheiten(Datenquelle: BASEC)
Cancer de la prostate métastatique hormono-naïf
Health conditions
(Datenquelle: WHO)
Metastatic Prostate Cancer
Seltene Krankheit
(Datenquelle: BASEC)
Nein
Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne)
(Datenquelle: 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
(Datenquelle: WHO)
Drug: abiraterone acetate;Radiation: radiotherapy;Other: Androgen Deprivation Therapy;Drug: Docetaxel
Kriterien zur Teilnahme an der Studie
(Datenquelle: 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
Ausschlusskriterien
(Datenquelle: 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
(Datenquelle: 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.)
-
Weitere Informationen zur Studie
Rekrutierungsstatus
Active, not recruiting
Wissenschaftlicher Titel
(Datenquelle: 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
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Datenquelle: WHO)
Phase 3
Primäre Endpunkte
(Datenquelle: WHO)
Survival
Sekundäre Endpunkte
(Datenquelle: 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
Kontakt für Auskünfte
(Datenquelle: WHO)
Please refer to primary and secondary sponsors
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsorte in der Schweiz
(Datenquelle: BASEC)
Genf, Lausanne
Durchführungsländer
(Datenquelle: WHO)
Belgium, France, Germany, Ireland, Italy, Portugal, Romania, Spain, Switzerland
Kontakt für weitere Auskünfte zur Studie
Angaben zur Kontaktperson in der Schweiz
(Datenquelle: BASEC)
Dominik Rudolph Berthold
+41 79 556 78 92
dominik.berthold@chuv.ch
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Karim FIZAZI, Professor;Alberto BOSSI, Doctor
Gustave Roussy, Cancer Campus Grand Paris - Paris
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Karim FIZAZI, Professor;Alberto BOSSI, Doctor
Gustave Roussy, Cancer Campus Grand Paris - Paris
Bewilligung durch Ethikkommission (Datenquelle: BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Datum der Bewilligung durch die Ethikkommission
18.05.2016
Weitere Studienidentifikationsnummern
Studienidentifikationsnummer der Ethikkommission (BASEC-ID)
(Datenquelle: BASEC)
2016-00277
Secondary ID (Datenquelle: WHO)
UC-0160/1105 GETUG AFU-21
Zurück zur Übersicht