metastatic Castration-Resistant Prostate Cancer (mCRPC)
Conditions
Brief summary
The OS comparison between treatments will be evaluated at each interim analysis and the final analysis using the stratified logrank test. The stratification factors are: 1. Prior docetaxel for castration-sensitive disease (Yes or No) 2. Visceral disease (presence or absence)
Detailed description
Time to event endpoints will be analyzed using a stratified logrank test with the same stratification factors. Kaplan-Meier estimates of SSE-free survival and radiographic PFS will be computed. The cumulative incidence function will be used to compute probabilities for the time to first skeletal related event and the time to ALP progression. All time to event probability estimates will be calculated within treatment., Total ALP response will be compared between the treatment groups using a CMH test adjusting for the randomization strata, Time to maximum % post-therapy decrease in PSA will be summarized using descriptive statistics, Maximum % decrease in PSA will be summarized using descriptive statistics (e.g., mean, standard deviation, median, minimum, and maximum), Longitudinal kernel smoothing methods will be used to estimate the PSA, bone marker, BSI, CTC, and ctDNA trajectories over time. Joint modeling will used to evaluate these trajectories with respect to OS, PROs will include scores from the QOL questionnaires: FACT-P, BPI, and BFI. The QOLs will be administered at baseline, week 19, Safety Follow Up, and Follow Up visits every 3 months for 1 year from last dose of either study drug. The scorespecific area under the curve (with respect to time) will be derived for each subject and these area-under-curve (AUCs) will be compared between treatments., The number and percentage of febrile neutropenia in subjects treated with docetaxel plus Radium-223, The percentage of treatment discontinuation in subjects who are on their fourth line of therapy will be calculated by treatment arm and total
Interventions
Sponsors
Memorial Sloan Kettering Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The OS comparison between treatments will be evaluated at each interim analysis and the final analysis using the stratified logrank test. The stratification factors are: 1. Prior docetaxel for castration-sensitive disease (Yes or No) 2. Visceral disease (presence or absence) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to event endpoints will be analyzed using a stratified logrank test with the same stratification factors. Kaplan-Meier estimates of SSE-free survival and radiographic PFS will be computed. The cumulative incidence function will be used to compute probabilities for the time to first skeletal related event and the time to ALP progression. All time to event probability estimates will be calculated within treatment., Total ALP response will be compared between the treatment groups using a CMH test adjusting for the randomization strata, Time to maximum % post-therapy decrease in PSA will be summarized using descriptive statistics, Maximum % decrease in PSA will be summarized using descriptive statistics (e.g., mean, standard deviation, median, minimum, and maximum), Longitudinal kernel smoothing methods will be used to estimate the PSA, bone marker, BSI, CTC, and ctDNA trajectories over time. Joint modeling will used to evaluate these trajectories with respect to OS, PROs will include | — |
Countries
Netherlands, Spain
Outcome results
None listed