ProBio: A Biomarker Driven Study in Patients With Metastatic Castrate Resistant Prostate Cancer
Status:
Recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
Metastatic castrate resistant prostate cancer (mCRPC) is an advanced form of prostate cancer
and it is estimated that around 20-30% of all prostate cancer diagnoses will develop mCRPC at
some point in their disease trajectory. The last years, new drugs have been approved for
treatment of mCRPC. Although the drugs are beneficial for many patients they carry three
serious disadvantages: treatment costs are high, the response rates are low and there are no
predictive treatment markers available in clinical care today. There are promising research
that linked changes in the tumor's genome with better or worse response to drug treatment.The
purpose of the ProBio study is to investigate whether profiling of the tumor's genome can be
used to select a treatment that is highly likely to produce good effect. In order to
investigate the tumor cells' genome we will use a biomarker in blood, so-called circulating
tumor DNA.
Our hypothesis is that one can significantly prolong progression-free survival compared to
current clinical practice by measuring free circulating tumor DNA in plasma and adapting the
treatment accordingly.
In this way, treatment can be tailored, which leads to benefits for both patient and health
care.
The hypothesis will be tested in a large clinical study with 750 patients diagnosed with
CRPC. Recruitment to the clinical treatment study will take place at a number of Swedish and
Belgian hospitals, and the study will be expanded to sites in Norway and Switzerland.
Phase:
Phase 3
Details
Lead Sponsor:
Henrik Grönberg Karolinska Institutet
Collaborators:
Janssen Pharmaceutica N.V., Belgium Kom Op Tegen Kanker The Swedish Research Council