Informations générales (source: ClinicalTrials.gov)
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-Naïve Prostate Cancer (PEACE1)
Interventional
Phase 3
UNICANCER (Voir sur ClinicalTrials)
novembre 2013
décembre 2032
14 novembre 2024
This is a multi-center phase III study to compare the clinical benefit of androgen
deprivation therapy with or without docetaxel with or without local radiotherapy with or
without abiraterone acetate and prednisone in patient with metastatic hormone-naïve
prostate cancer.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:21 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Karim FIZAZI | 28/05/2024 16:18:42 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre Azuréen de Cancérologie - 06250 - Mougins - France | Contact (sur clinicalTrials) | ||||
| Centre Catherine de Sienne - 44202 - Nantes Cedex 2 - France | Contact (sur clinicalTrials) | ||||
| CENTRE DE CANCEROLOGIE Paris Nord - Sarcelles - France | Contact (sur clinicalTrials) | ||||
| Centre de la Baie - Avranches - France | Contact (sur clinicalTrials) | ||||
| Centre d'Oncologie et de Radiothérapie du Pays Basque - 64100 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre d'Oncologie Saint Yves - Vannes - France | Contact (sur clinicalTrials) | ||||
| Centre Eugène Marquis - 35042 - RENNES Cedex - France | Contact (sur clinicalTrials) | ||||
| Centre François Baclesse - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Georges-François LECLERC - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Alpes Leman - 74130 - Contamine Sur Arve - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Intercommunal de Toulon - La Seyne sur Mer - Hôpital Sainte Musse - 83056 - Toulon - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69373 - Lyon cedex 08 - France | Contact (sur clinicalTrials) | ||||
| Centre Leonard de Vinci - Dechy - France | Contact (sur clinicalTrials) | ||||
| Centre Pierre Curie - Beuvry - France | Contact (sur clinicalTrials) | ||||
| CHD Vendée - 85925 - La ROCHE sur YON - France | Contact (sur clinicalTrials) | ||||
| Chic Quimper - 29107 - Quimper - France | Contact (sur clinicalTrials) | ||||
| CHP Saint Grégoire - 35760 - Saint Gregoire - France | Contact (sur clinicalTrials) | ||||
| CHR Orléans la source - 45100 - Orleans - France | Contact (sur clinicalTrials) | ||||
| CHU Carémeau - 30029 - NIMES Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Chu de Limoges - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU de TOURS Hôpital Bretonneau - Tours - France | Contact (sur clinicalTrials) | ||||
| Chu Jean Minjoz - 25030 - Besancon - France | Contact (sur clinicalTrials) | ||||
| CHU Lyon Sud - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU ST ETIENNE - Hôpital Nord - 44270 - Saint Etienne - France | Contact (sur clinicalTrials) | ||||
| Chu Timone - 13385 - MARSEILLE Cedex 5 - France | Contact (sur clinicalTrials) | ||||
| Clinique Armoricaine de radiologie - 22015 - Saint Brieuc - France | Contact (sur clinicalTrials) | ||||
| Clinique Claude Bernard - 81000 - Albi - France | Contact (sur clinicalTrials) | ||||
| Clinique Générale d'Annecy - 74000 - Annecy - France | Contact (sur clinicalTrials) | ||||
| Clinique Pasteur - 31076 - TOULOUSE Cedex 3 - France | Contact (sur clinicalTrials) | ||||
| Clinique Sainte Marguerite - 83400 - Hyères - France | Contact (sur clinicalTrials) | ||||
| Clinique Victor Hugo - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| Hôpital Nord - Marseille - France | Contact (sur clinicalTrials) | ||||
| Hôpital St Louis - 75010 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hopitaux du Leman - 74203 - Thonon-les-bains - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud - 31052 - TOULOUSE Cedex - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Lorraine - Vandœuvre-lès-Nancy - France | Contact (sur clinicalTrials) | ||||
| Institut de cancerologie de l'Ouest - 49933 - ANGERS Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie del'Ouest - site René Gauducheau - 44805 - Saint-herblain - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie Lucien Neuwirth - 42271 - St PRIEST EN JAREZ - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - Reims - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli Calmettes - 13273 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84918 - Avignon Cedex 9 - France | Contact (sur clinicalTrials) | ||||
| Strasbourg Oncologie Libérale - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
Critères
Homme
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/mm³
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.
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/mm³
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.
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.)