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

Andreas Josefsson

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Radiation: Radiotherapy; Procedure: Radical prostatectomy; Other: High-risk treatment SOC; Drug: Androgen deprivation therapy; Other: Active monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT06687421

SPRINTR-REAL

Details and patient eligibility

About

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.

Full 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

Enrollment: 5,500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,500 participants in 4 patient groups

Non-metastatic high-risk prostate cancer

Description:

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

Treatment:

Other: High-risk treatment SOC

Low risk prostate cancer

Description:

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

Treatment:

Other: Active monitoring

Medium risk prostate cancer

Description:

ISUP 2-3, PSA 10-20 µg/L

Treatment:

Procedure: Radical prostatectomy

Radiation: Radiotherapy

Metastatic prostate cancer

Description:

PSA \> 80 µg/L, clinically manifest metastases

Treatment:

Drug: Androgen deprivation therapy