prostate cancer
Conditions
Brief summary
“Occurrence of a high grade (3 to 5) adverse event” (yes/no), which will be analyzed 26 weeks after last patient first docetaxel dose (LPFD), will be summarized as adverse event (AE) rate (AER). A secondary safety endpoint is “Occurence of neutropenia grade 3/4 AE or death regardless of reason”, which will be summarized as neutropenia AE rate (NAER)
Detailed description
PSA-response (PSA ≤0.2, >0.2-4.0 und >4.0 ng/ml) determined at week 26 after LPFD, Time to castration-resistant prostate cancer, Overall survival, Time to initiation of subsequent antineoplastic therapy, Time to first symptomatic skeletal event (SSE), Time to pain progression, Time to worsening of physical symptoms of disease based on functional assessment of cancer therapy / National Comprehensive Cancer Network prostate cancer symptom index 17 item questionnaire (NCCN-FACT FPSI-17), Treatment emergent adverse events according to NCI-CTCAE version 5.0, Long-term overall safety and tolerability, Quality of life, Prostate-specific antigen (PSA) assessments, Docetaxel-exposure-response analysis
Interventions
DRUGProfact® Depot 6
DRUG3 mg 2-Monatsimplantat
Wirkstoff: Buserelin
DRUGPamorelin® LA 22
DRUG5 mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension
DRUGZoladex® 3
DRUG6 mg Implantat
DRUGELIGARD 22
DRUG5 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung
Sponsors
Friedrich-Schiller-Universitaet Jena
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| “Occurrence of a high grade (3 to 5) adverse event” (yes/no), which will be analyzed 26 weeks after last patient first docetaxel dose (LPFD), will be summarized as adverse event (AE) rate (AER). A secondary safety endpoint is “Occurence of neutropenia grade 3/4 AE or death regardless of reason”, which will be summarized as neutropenia AE rate (NAER) | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA-response (PSA ≤0.2, >0.2-4.0 und >4.0 ng/ml) determined at week 26 after LPFD, Time to castration-resistant prostate cancer, Overall survival, Time to initiation of subsequent antineoplastic therapy, Time to first symptomatic skeletal event (SSE), Time to pain progression, Time to worsening of physical symptoms of disease based on functional assessment of cancer therapy / National Comprehensive Cancer Network prostate cancer symptom index 17 item questionnaire (NCCN-FACT FPSI-17), Treatment emergent adverse events according to NCI-CTCAE version 5.0, Long-term overall safety and tolerability, Quality of life, Prostate-specific antigen (PSA) assessments, Docetaxel-exposure-response analysis | — |
Countries
Austria, Germany
Outcome results
None listed