Prostate cancer
Conditions
Brief summary
Number of lesions, Size of lesions, measured in mm, Location of lesions, distinguished in lymph node, bone, visceral, other, SUVmax, The appearance of at least 1 new PSMA-positive lesion compared to baseline PSMA PET/CT, with a SUVmax > liver (according to SPARC guidelines), A clinical significant increase in SUVmax of existing lesions (≥20%), An increase in the total number of metastatic lesions above 5 compared to baseline PSMA PET/CT (shifting from an oligo-metastatic to poly-metastatic disease stage)
Detailed description
Number of lesions, Size of lesions, measured in mm, Location of lesions, distinguished in lymph node, bone, visceral, other, SUVmax, Questionnaire on health-related quality of life, Number of AE and SAE, recorded by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Interventions
Sponsors
Amsterdam UMC Stichting
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of lesions, Size of lesions, measured in mm, Location of lesions, distinguished in lymph node, bone, visceral, other, SUVmax, The appearance of at least 1 new PSMA-positive lesion compared to baseline PSMA PET/CT, with a SUVmax > liver (according to SPARC guidelines), A clinical significant increase in SUVmax of existing lesions (≥20%), An increase in the total number of metastatic lesions above 5 compared to baseline PSMA PET/CT (shifting from an oligo-metastatic to poly-metastatic disease stage) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of lesions, Size of lesions, measured in mm, Location of lesions, distinguished in lymph node, bone, visceral, other, SUVmax, Questionnaire on health-related quality of life, Number of AE and SAE, recorded by NCI Common Terminology Criteria for Adverse Events (CTCAE v5.0) | — |
Countries
Netherlands
Outcome results
None listed