Multicenter Study Comparing Taxotere Plus Curcumin Versus Taxotere Plus Placebo Combination in First-line Treatment of Prostate Cancer Metastatic Castration Resistant (CURTAXEL)

Study Overview
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Brief Summary
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Multicenter randomized phase II study, double-blind, comparing Taxotere plus curcumin versus Taxotere plus placebo combination in first-line treatment of prostate cancer metastatic castration resistant. Assess time to progression (time to progression) of metastatic disease (from first day of treatment in the trial).

Conditions
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Prostate Cancer Metastatic Castration Resistant

Intervention / Treatment
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* Drug: Curcumin
* Drug: Placebo
* Drug: Taxotere


Participation Criteria
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Eligibility Criteria
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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 <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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin<br>curcumine capsule | Drug: Curcumin<br> <br> Drug: Taxotere<br> <br> |
| Placebo Comparator: Placebo<br>placebo capsule | Drug: Placebo<br> <br> Drug: Taxotere<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression | 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). From date of randomization until the date of first documented progression or date of death from any cause | participants will be followed post treatment. From date of randomization until the date of first documented progression or date of death from any cause | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSA response | Evaluate the PSA response (50% decrease compared to the initial value) | From date of randomization until the date of first documented PSA progression or date of death from any cause | 
| objective tumor response rate | Evaluate the objective tumor response rate (CR + PR) by RECIST. | participants will be evaluated at the end of the treatment (randomization + an expected average of 4 months) | 
| safety and tolerability | Assess the safety (adverse events) of the combination Taxotere/ curcumin. | patients will be followed for the duration of the treatment, an expected average of 4 months | 
| Pain | Assess pain in the short questionnaire on pain (QCD) | participants will be followed at Cycle1,3,6 of chemotherapy and post treatment (+1months after the end of the treatment) | 
| neuroendocrine markers | Assess serum neuroendocrine markers | participants will be followed for the duration of the treatment, an expected average of 4 months | 
| Overall survival | Evaluate overall survival (between inclusion and death whatever the cause) | from date of randomization until the date of death from any cause | 
| anti-angiogenic activity | Evaluate the anti-angiogenic activity of the association Taxotere ® plus curcumin | participants will be followed at each Cycle of chemotherapy ( + inclusion) , an expected average of 4 months | 
| compliance | Assess the compliance by curcumin treatment / placebo orally | patients will be followed for the duration of the treatment, an expected average of 4 months |