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

Launched by KAROLINSKA INSTITUTET · Apr 2, 2019

Keywords

ClinConnect Summary

The ProBio trial is studying new treatment options for men with metastatic prostate cancer, which means the cancer has spread beyond the prostate to other parts of the body. This trial is looking at two groups: one group will receive standard treatments that are commonly used, while the other group will receive treatments tailored to their specific cancer characteristics, identified through special tests on tissue or blood samples. The goal is to see if these personalized treatments can improve outcomes for patients.

To participate in this trial, men must have a confirmed diagnosis of prostate cancer that has spread and be starting treatment for it. They should be in good overall health and able to understand the trial information. The trial is currently recruiting participants, so if you or a loved one meet these criteria, you might consider getting involved. Participants can expect to be closely monitored throughout the study, and their treatment will be based on the specific features of their cancer, which may offer a more targeted approach to therapy.

Gender

MALE

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.