Implementation of Precision Medicine in High-risk Prostate Cancer

NCT06687421 | Recruiting

• 1 other identifier: SPRINTR-REAL
• Study Type: observational
• Target: 5,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Failure-free survival

  From enrollment to 20 years failure-free survival

Secondary Outcomes (5)

• Biomarker profiling

  From enrollment to 20 years.

• EORTC QLQ-C15-PAL

  From enrollment to 20 years.

• IPSS

  From enrollment to 20 years

• Costs for implementing precision medicine

  Before and after implementation of precision medicine workflows

• Cost effectiveness analysis

  From enrollment to 20 years

Study Arms (4)

Non-metastatic high-risk prostate cancer

ISUP ≥4, T3-4, or regional lymph node positive

Other: High-risk treatment SOC

Low risk prostate cancer

ISUP = 1, PSA \<10 µg/L, PSA-density \<0,15 µg/l/cm3

Other: Active monitoring

Medium risk prostate cancer

ISUP 2-3, PSA 10-20 µg/L

Procedure: Radical prostatectomy; Radiation: Radiotherapy

Metastatic prostate cancer

PSA \> 80 µg/L, clinically manifest metastases

Drug: Androgen deprivation therapy

Interventions

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)

Non-metastatic high-risk prostate cancer

Active monitoring OTHER

Followed with PSA measurements

Low risk prostate cancer

Radical prostatectomy PROCEDURE

Radical prostatectomy

Medium risk prostate cancer

Radiotherapy RADIATION

Radiotherapy

Medium risk prostate cancer

Androgen deprivation therapy DRUG

GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel

Metastatic prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Men investigated for suspected prostate cancer
• Signed consent form

You may not qualify if:

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

Sponsors & Collaborators

• Andreas Josefsson: lead
• Umeå University: collaborator

Study Sites (1)

Urology, Umeå University Hospital, Region Västerbotten

Umeå, 901 85, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue from diagnostic prostate biopsies for whole genome RNA and DNA sequencing and tissue evaluations (immunohistochemistry, digital pathology). In selected groups (primarily non-metastatic high risk PC) blood and urine will be sampled for analysis/identification of biomarkers as liquid biopsies

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Andreas Josefsson, MD, PhD

CONTACT

+46 907850000; andreas.josefsson@umu.se

Karin Welen, PhD

CONTACT

karin.welen@urology.gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor / Urologist

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: November 13, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 1, 2054
• Study Completion (Estimated): December 1, 2054
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting Jan 2025. Unending.
• Access Criteria: Proposal that describes planned analyses must be submitted and a data sharing agreement must be signed.

Locations

SE (1)