A Phase 2 interventional study of Curcumin and Placebo in Prostate Cancer Metastatic Castration Resistant, sponsored by Centre Jean Perrin. Terminated at 4 sites in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-24.
Sponsored by Centre Jean Perrin · Phase 2, Interventional, and Treatment
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).
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 50 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Centre Jean Perrin is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
curcumine capsule
Drug: Curcumin · Drug: Taxotere
placebo capsule
Drug: Placebo · Drug: Taxotere
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
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
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Centre Jean Perrin