Prostate cancer
Conditions
Brief summary
To evaluate progression free survival between the two treatment arms (radiographic, clinical, or prostate-specific antigen [PSA] progression-free survival). That is, time from start of treatment until signs of progressive disease. Where progression is defined according to Prostate Cancer Working Group 3(PCWG3) and RECIST v 1.1.
Detailed description
To evaluate and compare between the two treatment arms, time from start of treatment to death (disease specific and overall survival), To evaluate and compare between the two treatment arms, Objective response rate: Radiological and PSA response rate is evaluated at week 14 from start with study drugs according to PCWG3 and RECIST 1.1, To evaluate and compare between the two treatment arms, time to first symptomatic skeletal event (SSE), To evaluate and compare between the two treatment arms, Safety Quality of Life will be assested using FACT-P-T and BPI-SF, Evaluate toxic effect of dose on normal tissue and tumor in the experimental arm.
Interventions
DRUGABIRATERONE ACETATE
DRUGDEXAMETHASONE
DRUGONDANSETRON
DRUGBETAMETHASONE
DRUG[177Lu]PSMA-I&T
Sponsors
Region Västerbotten, Umea University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate progression free survival between the two treatment arms (radiographic, clinical, or prostate-specific antigen [PSA] progression-free survival). That is, time from start of treatment until signs of progressive disease. Where progression is defined according to Prostate Cancer Working Group 3(PCWG3) and RECIST v 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare between the two treatment arms, time from start of treatment to death (disease specific and overall survival), To evaluate and compare between the two treatment arms, Objective response rate: Radiological and PSA response rate is evaluated at week 14 from start with study drugs according to PCWG3 and RECIST 1.1, To evaluate and compare between the two treatment arms, time to first symptomatic skeletal event (SSE), To evaluate and compare between the two treatment arms, Safety Quality of Life will be assested using FACT-P-T and BPI-SF, Evaluate toxic effect of dose on normal tissue and tumor in the experimental arm. | — |
Countries
Sweden
Outcome results
None listed