Swedish Prostate Cancer Initiative for Novel Treatment Regimens - Real, Implementation of Precision Medicine in High-risk Prostate Cancer
Overview
- Phase
- N/A
- Intervention
- High-risk treatment SOC
- Conditions
- Prostate Cancer
- Sponsor
- Andreas Josefsson
- Enrollment
- 5500
- Locations
- 1
- Primary Endpoint
- Failure-free survival
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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
Investigators
Andreas Josefsson
Associate Professor / Urologist
Region Västerbotten
Eligibility Criteria
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
Arms & Interventions
Non-metastatic high-risk prostate cancer
ISUP ≥4, T3-4, or regional lymph node positive
Intervention: High-risk treatment SOC
Low risk prostate cancer
ISUP = 1, PSA \<10 µg/L, PSA-density \<0,15 µg/l/cm3
Intervention: Active monitoring
Medium risk prostate cancer
ISUP 2-3, PSA 10-20 µg/L
Intervention: Radical prostatectomy
Medium risk prostate cancer
ISUP 2-3, PSA 10-20 µg/L
Intervention: Radiotherapy
Metastatic prostate cancer
PSA \> 80 µg/L, clinically manifest metastases
Intervention: Androgen deprivation therapy
Outcomes
Primary Outcomes
Failure-free survival
Time Frame: From enrollment to 20 years failure-free survival
Secondary Outcomes
- Biomarker profiling(From enrollment to 20 years.)
- EORTC QLQ-C15-PAL(From enrollment to 20 years.)
- IPSS(From enrollment to 20 years)
- Costs for implementing precision medicine(Before and after implementation of precision medicine workflows)
- Cost effectiveness analysis(From enrollment to 20 years)