Newly diagnosed prostate cancer with pelvic lymph nodes metastases
Conditions
Brief summary
The failure-free survival is defined as the time from the date of randomization to clinical (new cancer-related symptoms), biochemical (PSA rising above nadir + 2ng/mL, phoenix criteria) or radiological (local relapse or new metastases) progression, death, end of 3-year follow-up period or lost to follow-up, whichever occurs first.
Detailed description
• Failure-free survival rates at 3 years., • Metastasis-free survival and Metastasis-free survival rates at 3 years : Metastasis-free survival is defined as the time from the date of treatment initiation to the date of increase in the number of metastatic pelvic lymph nodes, or death due to any cause, whichever is first., Progression-free survival and Progression-free survival rates at 3 years : Progression free survival is defined as the time from the date of treatment initiation to disease progression or death from any whichever is first. A progression is defined by radiological progression or biological progression or a clinical progression., Time to PSA response, Time to PSA progression defined as the time from baseline to the date of biochemical relapse as defined by the Phoenix criteria (increase of 2 ng/mL from nadir). PSA response rate (30%, 50%, 90%, undetectable = 0.2 ng/mL). PSA response is defined by the rate of patients having a decrease of > 30%, 50%, 90% or undetectable (0.2ng/mL) of their PSA level from baseline, as measured every 3 months., Overall survival and Survival rates at 3 years. Overall survival is defined as the time from treatment initiation to the date of documented death from any cause., Cancer-specific survival and Cancer-specific survival rates. Cancer-specific survival is defined as the time from treatment initiation to the date of documented death from prostate cancer or complication from the treatment, whichever occurs first, Time to pain progression (EVA scale), Toxicities (CTCAE v5.0), Quality of life ( EORTC QLQ-C302 and QLQ-PR253)
Interventions
DRUGPlacebo to BAY 1841788 300 mg film-coated tablet
DRUGLEUPRORELIN
DRUGBAY 1841788
DRUGDEGARELIX
DRUGTRIPTORELIN
Sponsors
ARTIC
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The failure-free survival is defined as the time from the date of randomization to clinical (new cancer-related symptoms), biochemical (PSA rising above nadir + 2ng/mL, phoenix criteria) or radiological (local relapse or new metastases) progression, death, end of 3-year follow-up period or lost to follow-up, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Failure-free survival rates at 3 years., • Metastasis-free survival and Metastasis-free survival rates at 3 years : Metastasis-free survival is defined as the time from the date of treatment initiation to the date of increase in the number of metastatic pelvic lymph nodes, or death due to any cause, whichever is first., Progression-free survival and Progression-free survival rates at 3 years : Progression free survival is defined as the time from the date of treatment initiation to disease progression or death from any whichever is first. A progression is defined by radiological progression or biological progression or a clinical progression., Time to PSA response, Time to PSA progression defined as the time from baseline to the date of biochemical relapse as defined by the Phoenix criteria (increase of 2 ng/mL from nadir). PSA response rate (30%, 50%, 90%, undetectable = 0.2 ng/mL). PSA response is defined by the rate of patients having a decrease of > 30%, 50%, 90% or undet | — |
Countries
France
Outcome results
None listed