Biomarker-driven treatment for metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

ProBio is an international, multi-arm, open-label trial designed to evaluate treatments for patients with metastatic prostate cancer based on specific biomarker signatures. Patients will be randomized into control or experimental arms, with the control group receiving standard care while the experimental group receives treatments tailored to their biomarker profiles identified through liquid biopsies or tissue samples. The trial focuses on both metastatic hormone-sensitive and castration-resistant prostate cancer, utilizing a gene panel to determine the most effective treatment options. This approach aims to personalize therapy and improve outcomes for patients with advanced prostate cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• OLV Ziekenhuis Aalst
  Aalst, Belgium Recruiting
• GZA Sint-Augustinus
  Antwerp, Belgium Recruiting
• AZ Sint-Jan AV
  Bruges, Belgium Recruiting
• AZ Sint-Lucas
  Bruges, Belgium Recruiting
• Ziekenhuis Oost-Limburg
  Genk, Belgium Recruiting
• University Hospital Ghent
  Ghent, Belgium Recruiting

Study contacts

• Principal investigator: Henrik Grönberg, Professor — Karolinska Institutet
• Study coordinator: Berit Larsson, MSc
• Email: berit.larsson@ki.se
• Phone: +46 8 52482576

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Exploring Terbium-161 PSMA Therapy for Advanced Prostate Cancer

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• REGN15505 Alone or With Cemiplimab or REGN4336 in Advanced Prostate Cancer and Kidney Cancer

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• Oral INR731 alone or with androgen receptor blockers for metastatic castration-resistant prostate cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.