Short summary

Advanced prostate cancer is heterogeneous, and treatment of mCRPC is complex due to androgen receptor defects. ADT is necessary but insufficient. Multiple treatment lines offer limited benefit, and response varies. No validated biomarkers exist to predict treatment effect. PSA is used but lacks specificity. This hypothesis-generating study investigates circulating biomarkers relevant to prostate cancer progression for future clinical use.

Rationale

The primary objective is to identify biomarkers, which alone or in combination can identify patients with and without benefit from treatment. Participation in this protocol does not influence treatment, and the patients are treated according to national and institutional guidelines. Endpoints Primary endpoint: • Progression free survival (PFS) - Radiologic PFS (rPFS) - Time to PSA progression Secondary endpoints: • Duration of response (DOR) • PSA response > 50% • Overall survival (OS)

Description of the cohort

- Patients with metastatic castration-resistant prostate cancer - Planned medical oncology treatment

Data and biological material

The biomarkers will be monitored at baseline and at treatment cycles. If a patient progresses on the first treatment, biomarker monitoring will continue during the next treatment regimens. If no progression has occurred, measurements will be performed at every follow-up visit.

Collaborating researchers and departments

Department of Clinical Immunology and Biochemistry, Vejle Hospital

• Molecular Biologist, PhD Rikke Fredslund Andersen
• Molecular Biologist, PhD Line Nederby