Malignancy of the prostate Prostate cancer
Conditions
Interventions
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Men >18 years of age. - Mentally competent and understanding of benefits and potential burden of the study. - Written and signed informed consent. - Histological confirmed diagnosis of adenocarcinoma of the prostate. - Indicated to start on hormonal therapy (any LHRH agonist or antagonist). - Indicated to start on upfront ARTA therapy (i.e. abiraterone or apalutamide). - Any initial PSA. - Any Gleason score. - Any T-stage. - Any N-stage. - Stage M1 (any; M1a, M1b, and/or M1c). - More than three (>3) metastatic lesions (any combination of either lymph node metastasis outside of pelvis, bone metastasis, or visceral metastasis), as seen on imaging (any combination of CT, MRI, skeletal scintigraphy, and/or (PSMA-)PET/CT-imaging).
Exclusion criteria
Exclusion criteria: - Concomitant malignancy (except from BCC of the skin). - History of prior diagnosed or treated PCa. - Any unrelated illness (e.g. active infection, inflammation or laboratory abnormalities) that in the judgment of the investigator will significantly affect patient*s clinical status. - Any known allergy for the upfront therapy. - Any known allergy for LHRH agonist. - Starting on other upfront combination therapy than abiraterone or apalutamide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary parameter: Predictive value of early response on PSMA-PET/CT to upfront therapy, according to PERCIST criteria and other analysis techniques. Primary endpoint: Time to development of CRPC. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters: Predictive value of early response on PSMA-PET/CT to hormonal therapy; predictive value of baseline PSMA-PET/CT, analysis of response in different subgroups of patients: e.g. high versus low tumour load, high versus low PSA, high versus low Gleason score, predictive values of different types of PSMA response evaluation methods (i.e. visually and quantitative methods). Secondary endpoint: Time to initiation of second line therapy after castration-resistant disease has been found. | — |
Countries
Netherlands
Contacts
Public ContactTrialbureau Divisie Beeld
Universitair Medisch Centrum Utrecht
Outcome results
None listed