Castrate-resistant prostate cancer with oligometastases on functional imaging (PSMA or choline/fluciclovine-positron-emission tomography).
Conditions
Brief summary
The superiority of stereotactic body radiation therapy combined with darolutamide to darolutamide alone for patients with CRPC having 1 to 5 oligometastases will be assessed using radiographic progression-free survival (rPFS).
Detailed description
Safety/tolerance will be assessed according to the incidence of AEs (graded using the NCI CTCAE v5.0)., Efficacy will be assessed using the Overall survival (OS), Time to treatment failure (TTF), Prostate cancer-specific survival, Time to PSA progression, Biochemical response rate, Time to next symptomatic skeletal event (SSE), Time to pain progression and Quality of life.
Interventions
Sponsors
Unicancer
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The superiority of stereotactic body radiation therapy combined with darolutamide to darolutamide alone for patients with CRPC having 1 to 5 oligometastases will be assessed using radiographic progression-free survival (rPFS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety/tolerance will be assessed according to the incidence of AEs (graded using the NCI CTCAE v5.0)., Efficacy will be assessed using the Overall survival (OS), Time to treatment failure (TTF), Prostate cancer-specific survival, Time to PSA progression, Biochemical response rate, Time to next symptomatic skeletal event (SSE), Time to pain progression and Quality of life. | — |
Countries
Belgium, France, Ireland, Spain
Outcome results
None listed