Synopsis-type Présentation projet de mémoire de DES d’Oncologie

Synopsis-type
Présentation projet de mémoire de DES d’Oncologie
TITRE
Carcinose péritonéale dans le cancer de prostate résistant à la castration
métastatique (CPRC) : incidence, survie sans ans progression (PFS), survie
globale (OS)
PROMOTEUR EVENTUEL
COORDINATEUR EVENTUEL
Pr Karim FIZAZI / Dr ARFI-ARROUCHE
TYPE D'ETUDE
Rétrospective observationnelle
OBJECTIF PRINCIPAL
Incidence, corrélation à la PFS et à l’OS
CRITERES D'EVALUATION
Incidence / PFS / OS
OBJECTIFS SECONDAIRES
Association à d’autres atteintes, à d’autres variables clinico-biologiques
CRITERES D'INCLUSION
 Détail en pièce jointe
Patients du GETUG 15 PEACE 1, d’une cohorte de CPRC précoce et CPRC
métastatique avancée
CRITERES DE NON
INCLUSION
Prédéfinis par les cohortes GETUG 15 PEACE 1, en cours d’élaboration pour les
autres cohortes
ESTIMATION DU
POTENTIEL D’INCLUSIONS
Environ 150 patients
HYPOTHESES
CPRC métastatique associé à une carcinose péritonéale : une entité à part ?
Pronostique différent et histoire naturelle d’évolution différente ?
NOMBRE DE PATIENTS
DUREE PREVISIBLE
DE L'ETUDE
CALENDRIER
PREVISIONNEL AVEC DATE
DE DEBUT ET DE FIN
TUTEUR
Pr Karim FIZAZI
FINANCEMENT
ASPECTS
REGLEMENTAIRES
CPP
ANSM
CNIL

Critères d’inclusion et d’exclusion patients PEACE 1
Inclusion criteria :
 Histologically or cytologically confirmed adenocarcinoma of the prostate,
 Metastatic disease documented by positive bone scan or CTscan or MRI. For patients with
nodal metastases only, only patients with extra-pelvic enlarged lymph nodes can be included
if they have either:
o At least one extra-pelvic lymph node ≥ 2 cm or
o extra-pelvic lymph node (s) ≥ 1 cm if the patients also have at least one pelvic lymph
node ≥ 2 cm
 Patients with ECOG ≤ 1 (PS 2 due to bone pain accepted),
 Life expectancy ≥ 6 months,
 Male aged ≥ 18 years old,
 Hemoglobin ≥ 10.0 g/dL,
 Platelet count ≥ 100,000/μL,
 Serum creatinine < 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min,
 Serum potassium ≥ 4.0 mmol/L,
 Serum bilirubin ≤ 1.5 x ULN (except documented Gilbert's disease); AST and ALT ≤ 2.5 x
ULN (≤ 5 ULN in case of liver metastases),
 Patients might have received a maximum of 3 months of ADT before randomization,
 Patients might have received previous radiation therapy directed to bone lesions
 Patients able to take oral medication,
 Patients who have received the information sheet and signed the informed consent form,
 Male patients who are receiving the study treatment and have partners of childbearing
potential are advised to use a method of birth control with 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 the study treatment.
 Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory
tests and other study procedures,
 Patients with a public or a private health insurance coverage,
o Additional criteria for patients receiving docetaxel:
 Patients willing to receive docetaxel
 Neutrophil ≥ 1500 cells/mm3
 Liver function: AST and ALT ≤ 1.5 x ULN; ALP ≤ 2.5 x ULN; Serum bilirubin ≤ 1.5 x
ULN.
 Male patients who will receive docetaxel and have partners of childbearing potential and/or
pregnant partners are advised to 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 6 months after the last dose of docetaxel.
Exclusion Criteria:

 Patients with previous local treatment directed to the prostate primary cancer. A previous
TURP is allowed,
 Prior cytotoxic chemotherapy or biological therapy for the treatment of prostate cancer,
 Any chronic medical condition requiring a higher dose of corticosteroid than 5mg
prednisone/prednisolone twice daily,
 Active infection or other medical condition for which corticosteroid use would be
contraindicated,
 Previously treated with ketoconazole for prostate cancer for more than 7 days,
 Prior systemic treatment with an azole drug within 4 weeks of randomization,
 Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg),
 Patients with a history of hypertension except if blood pressure is controlled by anti-
hypertensive treatment,
 Active or symptomatic viral hepatitis or chronic liver disease (except Gilbert's disease),
 History of pituitary or adrenal dysfunction,
 Small cell carcinoma of the prostate,
 Clinically known significant heart disease (myocardial infarction, arterial thrombotic events
in the past 6 months, severe or unstable angina,NYHA Class II-IV heart disease or cardiac
EF < 50% at baseline,
 Atrial Fibrillation, or other cardiac arrhythmia requiring therapy,
 Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence
within 24 months,
 Known allergies, hypersensitivity or intolerance to the study drugs or excipients,
 Administration of an investigational therapeutic within 30 days of D1,
 Patients already included in another therapeutic trial involving an experimental drug,
 Patients with significantly altered mental status prohibiting the understanding of the study or
with psychological, familial, sociological or geographical condition potentially hampering
participation,
 Individual deprived of liberty or placed under the authority of a tutor.
 Additional criteria for patients receiving docetaxel:
 Patients with impaired vision should undergo a prompt and complete ophthalmologic
examination. In case of Cystoid Macular Oeadema, the patient should not receive docetaxel.
 Concomitant use of strong CYP3A4 inhibitors (clarithromycin, indinavir, nefazodone,
nelfinavir, ritonavir, saquinavir, telithromycin) 23. Allergy to taxane
Critères d’inclusion et d’exclusion patients GETUG 15
Inclusion criterias:
 Prostate adenocarcinoma proven histologically
 Measurable or assessable metastatic disease
 Absence of previous chemotherapy for the metastatic prostate cancer

 Chemotherapy in an adjuvant or neoadjuvant situation or for elevation of PSA is accepted if
it was ended more than a year previously, with evidence of absence of progress on the PSA
or of appearance of metastases for more than a year.
 Adjuvant or neoadjuvant hormone therapy or hormone therapy for elevation of PSA is
accepted if it was ended more than a year previously, with evidence of absence of progress
on the PSA or of appearance of metastases for more than a year.
 Hormone therapy for the metastatic disease may have started but must not have been
administered for more than 2 months on inclusion in the trial.
 Any radiotherapy on the sites of metastases must have been completed at the time of
inclusion in the trial.
 Age ≥18 years
 ECOG ≤2
 Estimated survival≥3 months
 Leukocytes ≥2000/mm
 polynuclear neutrophils ≥1000/mm
 Platelets ≥100 000/mm
 Liver function satisfactory: bilirubin, transaminases ≤1.5 times the upper limit of normal (2.5
x normal in cases of liver metastases).
 Renal function satisfactory: serum creatinine ≤150 μmol/l
 Information for the patient and signature of the informed consentment.
Exclusion criterias:
 Severe cardiovascular disease (symptomatic coronary disease, congenital heart failure,
classes 3 and 4 of the NYHA classification)
 Severe peripheral neuropathy
 Active infection or other serious underlying disease which may prevent the patient from
receiving the treatment
 A history of cancer in the 5 years prior to inclusion in the study, other than treated baso-
cellular cutaneous cancer
 Patients who have had surgical castration
 Symptomatic or asymptomatic cerebral metastases which are not under control
 A patient taking part in another therapeutic trial protocol with an experimental compound
during the present study
 A history of or ongoing progressive psychiatric disease
 Impossibility of giving informed consent
 Impossibility of undergoing medical follow-up forgeographical, social, or psychological
reasons
 A patient protected by law