ProBio: A Biomarker Driven Study in Patients With Metastatic Castrate Resistant Prostate Cancer

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Male

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henrik Grönberg; Karolinska Institutet
• Collaborators: Janssen Pharmaceutica N.V., Belgium; Kom Op Tegen Kanker; The Swedish Research Council
• Treatments: Abiraterone Acetate; Carboplatin; Docetaxel; Niraparib; Pharmaceutical Solutions; Prednisone; Radium Ra 223 dichloride

Criteria

Inclusion Criteria:

• Man with metastatic castrate resistant prostate cancer (histologically confirmed prostate adenocarcinoma) and castrate levels < 50 ng/dl of serum

• Distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI

• Adequate health as assessed by the investigator to receive all available treatments in the trial

• ECOG/WHO (Eastern Cooperative Oncology Group/ World Health Organization) performance score 0-2

• Adequate organ and bone marrow function

• Albumin greater than or equal to 28 umol/L

• Able to understand the patient information and sign written informed consent

Exclusion Criteria:

• Other malignancies within 5 years except non-melanoma skin cancer

• Within 6 months of randomization: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA (transient ischemic attack), or congestive heart failure NYHA (New York Heart Association) class III or IV

• Uncontrolled hypertension

• Received systemic therapy (with the exception of standard ADT) prior to study inclusion, for the CRPC indication

• Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results

• Unable to comply with study procedures

• Current participation in another clinical trial that will be in conflict with the present study, administration of an investigational therapeutic or invasive surgical procedure within 28 days prior to study enrolment

• Patients who are unlikely to comply with the protocol

• Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subjects participation in this study.

• Any medical condition that would make use of the study treatments contraindicated, according to the SmPC, e.g. significant heart or liver disease.