Implementation of Precision Medicine in High-risk Prostate Cancer

Recruiting

Interventions: Other: High-risk treatment SOC
Other: Active monitoring
Procedure: Radical prostatectomy
Drug: Androgen deprivation therapy
Radiation: Radiotherapy

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

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Difficulties understanding information about the study due to linguistic, cognitive or other reason

Arm && Interventions

Group	Intervention	Description
Non-metastatic high-risk prostate cancer	High-risk treatment SOC	ISUP ≥4, T3-4, or regional lymph node positive
Low risk prostate cancer	Active monitoring	ISUP = 1, PSA \<10 µg/L, PSA-density \<0,15 µg/l/cm3
Medium risk prostate cancer	Radical prostatectomy	ISUP 2-3, PSA 10-20 µg/L
Medium risk prostate cancer	Radiotherapy	ISUP 2-3, PSA 10-20 µg/L
Metastatic prostate cancer	Androgen deprivation therapy	PSA \> 80 µg/L, clinically manifest metastases

Primary Outcome Measures

Name	Time	Method
Failure-free survival	From enrollment to 20 years failure-free survival

Secondary Outcome Measures

Name	Time	Method
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.

Locations (1): Urology, Umeå University Hospital, Region Västerbotten
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Umeå, Sweden

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