Prostate Cancer
Conditions
Brief summary
PSA response: percentage of patients with PSA decline ≥ 50% from baseline PSA value at 12-16 weeks and/or, Objective response rate: percentage of patients with radiographic response (partial or complete) during the first 16 weeks on follow up as per investigator assessment of soft tissue/visceral disease per RECIST 1.1, in subjects with measurable lesions.
Detailed description
Radiographic progression free survival (rPFS), based on RECIST v1.1 and/or PCGW3 guidelines, Time to PSA progression (TTPP), based on PCGW3 guidelines., Time to unequivocal clinical progression (TTCP), based on PCGW3 guidelines, Incidence of adverse events (AEs), based on CTCAE v.5.0 criteria
Interventions
Sponsors
Fundacion Oncosur
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response: percentage of patients with PSA decline ≥ 50% from baseline PSA value at 12-16 weeks and/or, Objective response rate: percentage of patients with radiographic response (partial or complete) during the first 16 weeks on follow up as per investigator assessment of soft tissue/visceral disease per RECIST 1.1, in subjects with measurable lesions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic progression free survival (rPFS), based on RECIST v1.1 and/or PCGW3 guidelines, Time to PSA progression (TTPP), based on PCGW3 guidelines., Time to unequivocal clinical progression (TTCP), based on PCGW3 guidelines, Incidence of adverse events (AEs), based on CTCAE v.5.0 criteria | — |
Countries
France, Spain
Outcome results
None listed