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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Clinique de la Chataigneraie
Beaumont, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Hospitalier Emile Roux
Le Puy-en-Velay, France
Institut Jean Godinot
Reims, France
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
Time frame: participants will be followed post treatment. From date of randomization until the date of first documented progression or date of death from any cause
PSA response
Evaluate the PSA response (50% decrease compared to the initial value)
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: participants will be followed for the duration of the treatment, an expected average of 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Overall survival
Evaluate overall survival (between inclusion and death whatever the cause)
Time frame: 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
Time frame: 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
Time frame: patients will be followed for the duration of the treatment, an expected average of 4 months