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NCT Number: NCT06687421

Implementation of Precision Medicine in High-risk Prostate Cancer

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.

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Urology, Umeå University Hospital, Region Västerbotten

Umeå, 901 85, Sweden

Location status: Recruiting

Location contact

Andreas Josefsson, MD, PhD

CONTACT

[email protected]

+46 907850000

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-risk treatment SOC

Other

radiotherapy (RT) + ADT (3 years) + Abiraterone acetate (2 years), with radical prostatectomy being an option if contraindication for RT exists)

Active Monitoring

Other

Followed with PSA measurements

radical prostatectomy

Procedure

Radical prostatectomy

Radiotherapy

Radiation

Radiotherapy

Androgen Deprivation Therapy

Drug

GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel

Primary outcomes

  1. Failure-free survival

    Time frame: From enrollment to 20 years failure-free survival

Secondary outcomes

  1. Biomarker profiling

    Time frame: 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.

  2. EORTC QLQ-C15-PAL

    Time frame: From enrollment to 20 years.

    Questionnaire on quality of life

  3. IPSS

    Time frame: From enrollment to 20 years

    Questionnaire on symptoms related to the prostate

  4. Costs for implementing precision medicine

    Time frame: 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.

  5. Cost effectiveness analysis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Josefsson, MD, PhD

CONTACT

[email protected]

+46 907850000

Karin Welen, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Andreas Josefsson

Other Gov

Collaborators

  • Umeå University

Registry information

Official study title

Swedish Prostate Cancer Initiative for Novel Treatment Regimens - Real, Implementation of Precision Medicine in High-risk Prostate Cancer

Acronym: SPRINTR-REAL

Important dates

Study start
2024
Primary completion
2054
Study completion
2054
First posted
Nov 13, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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