metastatic prostate cancer MedDRA version: 14.1 Level: LLT Classification code 10066489 Term: Progression of prostate cancer System Organ Class: 100000004864
Conditions
Sponsors
Centre Jean Perrin
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: - Age 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial). Progression was defined as an increase (of) injury (s) tumor (s) (RECIST) or an increase in PSA levels (= 25% and = 2ng/ml increase) or the appearance of new lesions metastatic (at least 2 new lesions for bone lesions).;Secondary Objective: Evaluate the PSA response (50% decrease compared to the value of the pre-processing). Evaluate the objective tumor response rate (CR + PR) by RECIST. Assess the safety of the combination Taxotere/ curcumin. Assess pain in the short questionnaire on pain (QCD), short version of the brief French Bread inventory. Assess serum neuroendocrine markers chromogranin A (CgA) and neuron specific enolase (NSE). Evaluate overall survival (between inclusion and death whatever the cause). Evaluate the anti-angiogenic activity of the association Taxotere ® plus curcumin (dosage serum VEGF). Assess the compliance by curcumin treatment / placebo orally for all patients included in the study.;Primary end point(s): - Evaluation of time to progression Time to progression was assessed by the time elapsed between the first day of treatment in the trial and when the disease progresses objectively regardless of initial response to treatment ..;Timepoint(s) of evaluation of this end point: Monitoring to assess the time to PSA progression will be monthly for one year and then every 3 months for 2 years and then every 6 months. Monitoring to assess time to progression (of) lesion (s) tumor (s) will be measured by an assessment visit to 3, 6, 9 and 12 months after the sixth treatment (the paraclinical evaluation will be at the discretion of the investigator after progression). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tumor response to target and non-target lesions The biological response will be evaluated on the evolution of PSA overall survival neuroendocrine markers tolerance Compliance;Timepoint(s) of evaluation of this end point: Tumor response was assessed by RECIST. The biological response was evaluated according to the PSA response. Neuro endocrine markers are evaluated by measuring the CgA and NSE. Tolerance will be assessed for each treatment and compliance. | — |
Countries
France
Contacts
Public ContactPouget Mélanie
Centre Jean perrin
Outcome results
None listed