NCT06687421

Implementation of Precision Medicine in High-risk Prostate Cancer

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,500 (estimated)
• Sponsor: Andreas Josefsson · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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)
OTHER	Active monitoring	Followed with PSA measurements
PROCEDURE	Radical prostatectomy	Radical prostatectomy
RADIATION	Radiotherapy	Radiotherapy
DRUG	Androgen deprivation therapy	GnRH agonist + abiraterone acetate/enzalutamide and/or docetaxel

Timeline

• Start date: 2024-06-10
• Primary completion: 2054-12-01
• Completion: 2054-12-01
• First posted: 2024-11-13
• Last updated: 2025-09-03

Locations

1 site across 1 country: Sweden