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

About This Trial

This study is for men whose prostate cancer has spread to other parts of the body and who are preparing to start a new treatment.
Researchers are testing whether selecting a treatment based on the unique genetic features of your tumor—found through blood or tissue tests—works better than standard care.
If you join, you will be randomly assigned to either receive standard treatment or a targeted therapy matched to your tumor's profile.
Before considering this trial, you should know that you must be in generally good daily health and cannot have had recent serious heart problems or other recent cancers.

ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer.
Patients will be randomized to control or experimental treatment arms.
Patients in the control arm will receive Standard of Care following national guidelines.
Patients in the experimental arm will be randomized to treatments based on a biomarker signature inferred from diagnostic tissue or liquid biopsy profiling.
The predefined biomarker signatures are tumor properties or mutations in genes/pathways with previously demonstrated clinical validity (e.g. prognostic value or association with treatment response).
The biomarker signatures are identified using a hybridisation capture gene panel specifically designed for prostate cancer.

Age Range: 18 years and older
Gender: Male
Who This Trial is For: This study is for men whose prostate cancer has spread to other parts of the body and who are preparing to start a new treatment.

Full Eligibility Criteria

Inclusion Criteria

Man with histologically confirmed prostate adenocarcinoma, initiating systemic therapy for metastatic disease, encompassing newly diagnosed (i.e. de novo) hormone sensitive prostate cancer (mHSPC) or first-line castration resistant prostate cancer (mCRPC)
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 g/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
Uncontrolled hypotension
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.