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

Summary

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.

Eligibility

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.

Conditions3

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