ProBio (Prostate Biomarkers) - a clinical study with the goal to improve treatment selection for men with advanced prostate cancer.
Background

All tissues contain cells that have specific functions, e.g. cells in the eye register light to allow for us to see. Most human cells contain a full copy of the DNA obtained from each parent. A full copy of DNA is often referred to as the human genome.

Cancer is caused by DNA damage that occur as part of the normal ageing process or by exposure to for example cigarette smoke. The DNA damage that cause cancer give the cancer cells the ability to grow and spread in the human body. Prostate cancer is one of the most common forms of cancer and mainly affects elderly men. Although all prostate cancers originate from the same organ, the tumors have different properties depending on where the DNA damage is located in genome (DNA) of the cancer cells.

By analyzing the DNA of the cancer cells, by using so called DNA-sequencing, it is possible to determine the exact genes affected by DNA damage that are not working normally in the cancer cells. During recent years research has demonstrated for other cancer types that patients with DNA damage in certain genes will respond better to certain treatments. Although treatment selection based on DNA sequencing has great potential for improving treatment selection for advanced prostate cancer, the approach needs to be evaluated in a clinical trial.

The purpose of ProBio

The purpose of the ProBio project is to determine which treatment that is optimal for an individual prostate cancer patient based on analysis of the cancer DNA. This concept is called “personalized treatment selection” and has revolutionized patient care for many types of cancer. In the ProBio trial, researchers will investigate how “personalized treatment selection” is best applied for advanced prostate cancer.

What is analysed in ProBio?

Preferably, DNA will be analyzed that has leaked into the blood from broken and dying tumor cells. However and to ensure a complete analysis for all study participants, leftover tissue available from the diagnostic prostate biopsies might be DNA-sequenced. DNA from the body's normal blood cells will also be analyzed as this can also provide information on which treatment that is most appropriate.

How to join ProBio?

A patient being treated at a hospital listed here , can ask his treating doctor if it is possible to join the ProBio trial.

What happens to a patient that decides to join ProBio?

If a patient decides to join ProBio DNA analysis will be performed. The so called genetic analysis can take two weeks and the result is then entered into a computer program which determines what treatment you as a participant will receive; either standard treatment determined by the doctor or a treatment based on the genetic analysis.

Are there any benefits to participating in ProBio?

There are no guaranteed advantages by joining ProBio. A patient that joins ProBio will be given the opportunity to try a new way of determining which treatment is most suitable and to participate in a clinical trial that hopefully will be of benefit to the patient and to others in the future.

Will ProBio lead to better care for metastatic prostate cancer patients?

The focus of the ProBio team is to improve treatment selection and quality of life for men with advanced prostate cancer. We are striving to make our DNA-sequencing technology available for patients not participating in the ProBio-trial and hope that our efforts will lead to the implementation of “personalized treatment selection” in routine healthcare.