Short summary

Prostate cancer is the most common type of cancer among men in Denmark. The current state of the art in first-line treatment is either radical prostatectomy or curative radiotherapy with or without androgen deprivation therapy (ADT) in patients with intermediate or high-risk prostate cancer when there is no evidence of metastases and life expectancy is more than 10 years. However, we still lack knowledge as to which patients will be cured by radiotherapy.

Rationale

PSA is known to be specific for prostate glands but not for prostate cancer. At present we have no other validated biomarkers applicable for predicting the effect of radiotherapy as indicated by early recurrence.

The primary objective is to investigate the prognostic value of selected biomarkers before and after completed curatively intended treatment with radiotherapy for prostate cancer. The selected biomarkers can hopefully predict early relapse following curatively intended radiotherapy in prostate cancer.

In this protocol we have choosen to focus on variants in genetic and epigenetic signatures as well as selected immune status markers, that are all suggested to contribute to prostate carcinogenesis, metastatic potential, and progression to castration resistant disease.

Primary endpoint:

• 3-year PSA relapse-free survival

Secondary endpoints:

• 5-year PSA relapse-free survival

• Overall survival

Inclusion criteria

• Conventional curatively intended radiotherapy for primary prostate cancer. Concurrent ADT is permitted.

• Age > 18 years.

• Written and orally informed consent.

• Consent to translational research and biobank.

Exclusion criteria

• Distant metastases.

• Severe co-morbidity making the patient unlikely to complete the planned 5-year follow-up period.

• Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer

The biomarkers will be monitored at baseline, immediately after treatment and during follow-up, and the lead time from changes to the detection of PSA relapse will be investigated.

Description of the cohort

Men with intermediate or high-risk prostate cancer who are referred for curative radiotherapy.

Data and biological material

Blood will be monitored at baseline, immediately after treatment and during follow-up.

Collaborating researchers and departments

Department of Urology, Vejle Hospital

• MD, PhD Bettina Nørby

Department of Urology, Hospital of Southwest Jutland

• MD Søren Madsen

Department of Clinical Immunology and Biochemistry, Vejle Hospital

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