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.
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
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
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Treatment groupsSee each treatment group below.
Karolinska Institutet
Lead sponsor
The Swedish Research Council
Collaborator
Kom Op Tegen Kanker
Collaborator
Janssen Pharmaceutica N.V., Belgium
Collaborator
AstraZeneca
Collaborator
Cancerfonden
Collaborator