Oligoprogressive metastatic castration-refractory prostate cancer
Conditions
Brief summary
Overall survival (OS) will be calculated from the day of randomization until death from any cause.
Detailed description
Quality of life (QOL): Quality of life scoring using the EORTC QLQ-C30 supplement with QLQ-PR25. We will assess the quality-of-life-years with the EuroQOL classification system (EQ-5D-5L). Assessments are planned at baseline and during follow-up consultation at month M1, M3, M6, M12 and M24., Cancer specific survival: Cancer specific survival (CSS) will be calculated from the day of randomization until PCa death., Radiographic progression free survival: Radiographic progression free survival will be calculated from the day of randomization until the first day of progression (local, nodal or metastatic) on conventional imaging or PSMA PET-CT. rPFS will be determined using the same imaging modality employed at baseline. Imaging is performed every 6 months during follow-up or at any time in case of PSA progression or symptoms., Metastasis-directed therapy induced acute and late toxicity scoring: Acute and late toxicity as a result of radiotherapy will be scored using the Common Toxicity Criteria Version 5.0 (21). Toxicity will be scored at every follow-up visit., Cost-effectiveness of metastasis-directed therapy in patients with oligoprogressive metastatic castration-refractory prostate cancer., 18F PSMA PET-CT prediciton value in patients with oligoprogressive metastatic castration-refractory prostate cancer.
Interventions
DRUGLynparza 150 mg film-coated tablets
DRUGAkeega 100 mg/500 mg film-coated tablets
Sponsors
UZ Leuven
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) will be calculated from the day of randomization until death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (QOL): Quality of life scoring using the EORTC QLQ-C30 supplement with QLQ-PR25. We will assess the quality-of-life-years with the EuroQOL classification system (EQ-5D-5L). Assessments are planned at baseline and during follow-up consultation at month M1, M3, M6, M12 and M24., Cancer specific survival: Cancer specific survival (CSS) will be calculated from the day of randomization until PCa death., Radiographic progression free survival: Radiographic progression free survival will be calculated from the day of randomization until the first day of progression (local, nodal or metastatic) on conventional imaging or PSMA PET-CT. rPFS will be determined using the same imaging modality employed at baseline. Imaging is performed every 6 months during follow-up or at any time in case of PSA progression or symptoms., Metastasis-directed therapy induced acute and late toxicity scoring: Acute and late toxicity as a result of radiotherapy will be scored using the Common Toxicity C | — |
Countries
Belgium
Outcome results
None listed