Aggressive Variant Metastatic Castration Resistant Prostate Cancer
Conditions
Brief summary
Radiographic Progression-free survival (rPFS) rate at 6 months. Radiographic Progression-Free Survival is defined from the date of first dose of study treatment to the date of radiographic confirmed progression or death (from any cause), whichever occurs first, Incidence of adverse events (AEs) graded according to NCI-CTCAE v 5.0 criteria
Detailed description
Radiographic Progression free-survival at 12 months, Response rate by PCWG3 modified RECIST 1.1, PSA response (when PSA is evaluable), PSA progression-free survival, Progression-free survival, Overall survival, Abnormalities in vital signs, laboratory test values, and ECG data, Treatment modifications, Patients’ withdrawals for safety reasons, Exploratory biomarkers (including but not limited to proteins, tumor tissue-derived DNA and circulating cell-free DNA) will be collected before treatment, during treatment and at disease progression, We will determine androgen receptor N-terminus (AR441, Carpinteria, CA, USA), androgen receptor C-terminus (SP242, Abcam, Cambridge, UK) and Ki67 (M724001-2, Dako, Glostrup, Denmark)., We will collect and analyze tumor tissue, whole blood and plasma nucleic acids (DNA and RNA) in future research.
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGCARBOPLATIN
DRUGCABAZITAXEL
Sponsors
Fundación Oncosur
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic Progression-free survival (rPFS) rate at 6 months. Radiographic Progression-Free Survival is defined from the date of first dose of study treatment to the date of radiographic confirmed progression or death (from any cause), whichever occurs first, Incidence of adverse events (AEs) graded according to NCI-CTCAE v 5.0 criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Progression free-survival at 12 months, Response rate by PCWG3 modified RECIST 1.1, PSA response (when PSA is evaluable), PSA progression-free survival, Progression-free survival, Overall survival, Abnormalities in vital signs, laboratory test values, and ECG data, Treatment modifications, Patients’ withdrawals for safety reasons, Exploratory biomarkers (including but not limited to proteins, tumor tissue-derived DNA and circulating cell-free DNA) will be collected before treatment, during treatment and at disease progression, We will determine androgen receptor N-terminus (AR441, Carpinteria, CA, USA), androgen receptor C-terminus (SP242, Abcam, Cambridge, UK) and Ki67 (M724001-2, Dako, Glostrup, Denmark)., We will collect and analyze tumor tissue, whole blood and plasma nucleic acids (DNA and RNA) in future research. | — |
Countries
Spain
Outcome results
None listed