Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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
Interventions
OTHERHigh-risk treatment SOC
radiotherapy (RT) + ADT (3 years) + Abiraterone acetate (2 years), with radical prostatectomy being an option if contraindication for RT exists)
OTHERActive monitoring
Followed with PSA measurements
PROCEDURERadical prostatectomy
Radical prostatectomy
RADIATIONRadiotherapy
Radiotherapy
DRUGAndrogen deprivation therapy
GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel
Sponsors
Umeå University
Andreas Josefsson
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men investigated for suspected prostate cancer * Signed consent form
Exclusion criteria
* Difficulties understanding information about the study due to linguistic, cognitive or other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Failure-free survival | From enrollment to 20 years failure-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomarker profiling | From enrollment to 20 years. | 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. |
| EORTC QLQ-C15-PAL | From enrollment to 20 years. | Questionnaire on quality of life |
| IPSS | From enrollment to 20 years | Questionnaire on symptoms related to the prostate |
| Costs for implementing precision medicine | Before and after implementation of precision medicine workflows | 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. |
| Cost effectiveness analysis | From enrollment to 20 years | 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. |
Countries
Sweden
Contacts
Primary ContactAndreas Josefsson, MD, PhD
Backup ContactKarin Welen, PhD
Outcome results
None listed