This project's objective is to initiate a prospective non-interventional clinical study to perform full molecular characterization and subtyping of the primary tumor prostate cancer patients. It will identify, compare, and select biomarkers for treatment response in high-risk/metastatic prostate cancer.
This prospective study includes molecular characterization of the primary tumor, biobanking of urine and blood, questionnaires, collection of health economic parameters, cross-checking of registries to link both other diagnoses and drug use to the different biomarkers and socio-economic parameters. Clinical variables including imaging and routine pathology and the outcome of the molecular diagnostic analysis should, in addition to the basic scientific purpose, also be able to identify men who may be eligible for other studies, both pharmaceutical company-funded and investigator-initiated studies. One aim is also to develop the national medical information system already in place for prostate cancer (individual patient record) with molecular profiling and other variables for health estimation, health economics and also enable retrieval from more registries. This study will form the basis for the start of a nationwide study with the aim to prioritize biomarkers for the development of treatment predictive algorithms
Study Type
OBSERVATIONAL
Enrollment
5,500
radiotherapy (RT) + ADT (3 years) + Abiraterone acetate (2 years), with radical prostatectomy being an option if contraindication for RT exists)
Followed with PSA measurements
Radical prostatectomy
Urology, Umeå University Hospital, Region Västerbotten
Umeå, Sweden
RECRUITINGFailure-free survival
Time frame: From enrollment to 20 years failure-free survival
Biomarker profiling
Molecular and imagebased characterization of primary tumor. RNA-sequencing, DNA -sequencing, whole genome arrays, analysis of immunohistochemical markers such as Ki67, PSA and AR will be performed as well as MR and PSMA-PET imaging.
Time frame: From enrollment to 20 years.
EORTC QLQ-C15-PAL
Questionnaire on quality of life
Time frame: From enrollment to 20 years.
IPSS
Questionnaire on symptoms related to the prostate
Time frame: From enrollment to 20 years
Costs for implementing precision medicine
Evaluation of costs for implementing precision medicine tools including tumor profiling in the clinical workflow. Registration of all time required for handling of patient samples from referral to the clinic until diagnosis decision and cost for preparation/analysis of tissue for molecular characterization.
Time frame: Before and after implementation of precision medicine workflows
Cost effectiveness analysis
Evaluation of health economical costs measured by both crude costs for precision medicine workflow plus specific targeted treatments with or without quality-adjusted life years analysis. Data will be collected from health registries and surveys for quality of life evaluation.
Time frame: From enrollment to 20 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Radiotherapy
GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel