Implementation of Precision Medicine in High-risk Prostate Cancer (SPRINTR-REAL)

Swedish Prostate Cancer Initiative for Novel Treatment Regimens - Real, 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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Radiotherapy; Procedure: Radical prostatectomy; Other: High-risk treatment SOC; Other: Active monitoring; Drug: Androgen deprivation therapy

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

• Study Type: Observational
• Enrollment (Estimated): 5500

Contacts and Locations

• Study Contact: Name: Andreas Josefsson, MD, PhD; Phone Number: +46 907850000; Email: andreas.josefsson@umu.se
• Study Contact Backup: Name: Karin Welen, PhD; Email: karin.welen@urology.gu.se

Study Locations

• Sweden
  • Umeå, Sweden, 901 85
    • Recruiting
    • Urology, Umeå University Hospital, Region Västerbotten
    • Contact: Andreas Josefsson, MD, PhD; Phone Number: +46 907850000; Email: andreas.josefsson@umu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All men who come for biopsy as a part of the investigation for suspected prostate cancer will be invited to participate.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-metastatic high-risk prostate cancer; ISUP ≥4, T3-4, or regional lymph node positive	Other: 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	Other: Active monitoring; Followed with PSA measurements
Medium risk prostate cancer; ISUP 2-3, PSA 10-20 µg/L	Radiation: Radiotherapy; Radiotherapy; Procedure: Radical prostatectomy; Radical prostatectomy
Metastatic prostate cancer; PSA > 80 µg/L, clinically manifest metastases	Drug: Androgen deprivation therapy; GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Failure-free survival	From enrollment to 20 years failure-free survival

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarker profiling	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.	From enrollment to 20 years.
EORTC QLQ-C15-PAL	Questionnaire on quality of life	From enrollment to 20 years.
IPSS	Questionnaire on symptoms related to the prostate	From enrollment to 20 years
Costs for implementing precision medicine	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.	Before and after implementation of precision medicine workflows
Cost effectiveness analysis	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.	From enrollment to 20 years

Collaborators and Investigators

• Sponsor: Andreas Josefsson
• Collaborators: Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): December 1, 2054
• Study Completion (Estimated): December 1, 2054

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 13, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Androgen Antagonists; Radiotherapy
• Other Study ID Numbers: SPRINTR-REAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

All collected research data apart from identifiable data can be shared pseudonymised.

In most cases results will be presented at group level. However if analysis results at the individual level will be presented baseline information will be presented in the form of intervals to prevent the research subject from being identified. Baseline information could be e.g. age and lab values. Therefore shared data will not be directly traceable to an individual participant.

• IPD Sharing Time Frame: Starting Jan 2025. Unending.
• IPD Sharing Access Criteria: Proposal that describes planned analyses must be submitted and a data sharing agreement must be signed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No