Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Centre Jean Perrin
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Patient older than 18 years.
Performance status ≤ 2 according to the WHO criteria.
Life expectancy\> 3 months.
Patient in hormonal blockade based on surgical castration by orchiectomy or pulpectomy, medical or agonist or antagonists of LHRH associated or not with anti-androgens or any other treatment that blocks the fraction of non-gonadal testosterone, resulting in a testosterone \<0.5 ng / mL.
Patient with adenocarcinoma of the prostate and histologically proven metastatic castration-resistant stage, defined by: objective progression of at least one measurable tumor target and / or assessable by RECIST, and / or increase in PSA ("rising PSA").
Satisfactory biological functions (renal, hepatic and hematologic)
Patient who signed the consent for participation before entering the study.
Affiliation to a social security scheme (or be the beneficiary of such a plan) under the terms of the law of 9 August 2004.
You may not be if
Age \<18 years.
Performance status\> 2 according to the WHO criteria.
Patient deprived of liberty or under guardianship, patient with (the) condition (s) psychological, family, social or geographic may interfere with the proper conduct of the study.
Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer considered cured.
Patient with brain metastases at initial assessment.
Patient with another pathology deemed incompatible with the inclusion in the protocol.
Laboratory tests inadequate.
History of malabsorption syndrome or extensive resection of the upper digestive tract.
Uncontrolled intercurrent infection.
Pathology autoimmune and / or chronic active inflammation.
peripheral neuropathy grade 2 according to the criteria of the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.0).
History of allergy to polysorbate 80.
Treatment with nonsteroidal anti-inflammatory and / or cyclooxygenase-2 dated within three weeks.
Concomitant with a drug test or participation in another clinical trial within \<30 days treatment.
Regular Taking dietary supplements.
Clareo Health | Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)