Implementation of Precision Medicine in High-risk Prostate Cancer
NCT ID: NCT06687421
Last Updated: 2025-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5500 participants
OBSERVATIONAL
2024-06-10
2054-12-31
Brief Summary
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It will identify, compare, and select biomarkers for treatment response in high-risk/metastatic prostate cancer.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-metastatic high-risk prostate cancer
ISUP ≥4, T3-4, or regional lymph node positive
High-risk treatment SOC
radiotherapy (RT) + ADT (3 years) + Abiraterone acetate (2 years), with radical prostatectomy being an option if contraindication for RT exists)
Low risk prostate cancer
ISUP = 1, PSA \<10 µg/L, PSA-density \<0,15 µg/l/cm3
Active monitoring
Followed with PSA measurements
Medium risk prostate cancer
ISUP 2-3, PSA 10-20 µg/L
Radical prostatectomy
Radical prostatectomy
Radiotherapy
Radiotherapy
Metastatic prostate cancer
PSA \> 80 µg/L, clinically manifest metastases
Androgen deprivation therapy
GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel
Interventions
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High-risk treatment SOC
radiotherapy (RT) + ADT (3 years) + Abiraterone acetate (2 years), with radical prostatectomy being an option if contraindication for RT exists)
Active monitoring
Followed with PSA measurements
Radical prostatectomy
Radical prostatectomy
Radiotherapy
Radiotherapy
Androgen deprivation therapy
GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel
Eligibility Criteria
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Inclusion Criteria
* Signed consent form
Exclusion Criteria
18 Years
MALE
No
Sponsors
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Umeå University
OTHER
Andreas Josefsson
OTHER_GOV
Responsible Party
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Andreas Josefsson
Associate Professor / Urologist
Locations
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Urology, Umeå University Hospital, Region Västerbotten
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SPRINTR-REAL
Identifier Type: -
Identifier Source: org_study_id
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