Implementation of Precision Medicine in High-risk Prostate Cancer

NCT ID: NCT06687421

Last Updated: 2025-09-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

5500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-10

Study Completion Date

2054-12-31

Brief Summary

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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

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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

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

Followed with PSA measurements

Medium risk prostate cancer

ISUP 2-3, PSA 10-20 µg/L

Radical prostatectomy

Intervention Type PROCEDURE

Radical prostatectomy

Radiotherapy

Intervention Type RADIATION

Radiotherapy

Metastatic prostate cancer

PSA \> 80 µg/L, clinically manifest metastases

Androgen deprivation therapy

Intervention Type DRUG

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)

Intervention Type OTHER

Active monitoring

Followed with PSA measurements

Intervention Type OTHER

Radical prostatectomy

Radical prostatectomy

Intervention Type PROCEDURE

Radiotherapy

Radiotherapy

Intervention Type RADIATION

Androgen deprivation therapy

GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Umeå University

OTHER

Sponsor Role collaborator

Andreas Josefsson

OTHER_GOV

Sponsor Role lead

Responsible Party

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Andreas Josefsson

Associate Professor / Urologist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Urology, Umeå University Hospital, Region Västerbotten

Umeå, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Andreas Josefsson, MD, PhD

Role: CONTACT

+46 907850000

Karin Welen, PhD

Role: CONTACT

Facility Contacts

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Andreas Josefsson, MD, PhD

Role: primary

+46 907850000

Other Identifiers

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SPRINTR-REAL

Identifier Type: -

Identifier Source: org_study_id

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