Etude : TACTIK / GETUG-AFU-28



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : TACTIK

Nom : GETUG-AFU-28

Traitement : Métastatique ou localement avancé

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 07/05/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Traitement personnalisé des patients atteints d'un cancer métastatique de la prostate résistant à la castration en fonction de la cinétique des cellules tumorales circulantes au cours de la chimiothérapie

Spécialité : Organes génitaux masculins
Localisation : C61 - Tumeur maligne de la prostate
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This study compares the biological activity of cabazitaxel (6 cycles) to that of docetaxel (6 cycles) in metastatic castrate-resistant prostate cancer (mCRPC) patients with docetaxel resistant mCPRC defined as ≥5CTCs / 7.5mL after 2 cycles of docetaxel.

Patients with docetaxel resistant metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients with ≥5CTCs / 7.5mL before docetaxel chemotherapy and after 2 cycles of docetaxel) will receive either 6 additional cycles of docetaxel or 6 additional cycles of cabazitaxel after randomisation.

A cohort of patients with docetaxel sensitive metastatic castration-resistant prostate cancer (mCRPC) based on circulating tumor cell (CTC) enumeration (patients ≥5CTCs / 7.5mL before docetaxel chemotherapy and <5CTCs / 7.5mL after 2 cycles of docetaxel) will receive 6 additional cycles of docetaxel.

Phase : II

Stade : Métastatique

1, 2
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Written informed consent signed prior any study-related procedures
- Adult men ≥18 years
- Histologically confirmed prostate adenocarcinoma
- Metastatic disease as evidenced by imaging (bone scan, CT-scan, MRI and/or PET-choline).
- Documented progressive disease while receiving continuous hormonal treatment with LH-RH agonist or antagonist or after surgical castration (at least one visceral or soft tissue metastatic lesion, including a new lesion). Patient with non-measurable disease must have documented rising PSA levels or appearance of new lesion
- Effective castration assessed by testosterone levels ≤50 ng/dL
- Patients with a performance status ECOG ≤2
- Patients affiliated to social security scheme

Critères de non-inclusion : - Prior chemotherapy for metastatic prostate cancer except estramustine <1 year from the end of adjuvant and/or neoadjuvant chemotherapy for localized disease <1 year from the end of chemotherapy for de novo metastatic prostate cancer
- Prior isotope therapy, whole pelvic radiotherapy or radiotherapy to >30% of bone marrow
- Less than 1 month elapsed from prior treatment with radiotherapy, surgery and less than 2 weeks from any previous hormonal treatment except for LH-RH agonists/antagonists (which are to be continued). Patients may be treated with bisphosphonates prior to study entry which should be pursued,
- History of brain metastases, uncontrolled spinal cord compression, carcinomatous meningitis or new evidence of brain or leptomeningeal disease
- Patient with any of the following abnormal laboratory tests: hemoglobin <10 g/dL, absolute neutrophil count <1.5 x 10⁹/L, platelets <100 x 10⁹/L, AST/SGOT and/or ALT/SGPT >1.5 x upper limit of normal (ULN), total bilirubin >1.0 ULN, creatinine clearance <40 ml/mn (MDRD)
- History of hypersensitivity to polysorbate 80 or docetaxel
- Contraindication to the use of corticosteroids
- Peripheral neuropathy grade ≥2 according to NCI CTCAE v4.0
- Ventricular ejection fraction <50% (echography or scintigraphy)
- Any of the following within 6 months prior to study entry: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack
- Any of the following within 3 months prior to study entry: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, inflammatory bowel disease, pulmonary embolism or other uncontrolled thromboembolic event
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormally that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Planned vaccination with a live or live-attenuated vaccines
- Participation in another clinical trial and any treatment with any investigational drug within 30 days prior to randomization
- Any illness or problem including geographic, psychiatric or psychological which is incompatible with being monitored during the trial
- Patients with reproductive potential who do not agree to use effective method of contraception during the treatment
- Person deprived of their liberty or under protective custody or guardianship
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03101046
Promoteur :
UNICANCER
Type de sponsor : Institutionnel
- 75654 Paris Cedex 13
75001 PARIS 01

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN
Apicrypt : essaitherapeutiquecfb@baclesse.unicancer.fr

Investigateur :
Elodie COQUAN

TEC / ARC / IDE :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Statut de l'essai : OUVERT

MAJ : 07/05/2020