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

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 de

Trial Details

NCT ID
NCT03903835
Phase
PHASE3
Sponsor
Karolinska Institutet
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • Enzalutamide Oral Capsule
  • Abiraterone Oral Tablet
  • Carboplatin
  • Cabazitaxel 60 mg Solution for Injection
  • Docetaxel Injectable Solution
  • Radium Chloride Ra-223
Locations (sample)
  • Aalst, Belgium|50.93604,4.0355
  • Antwerp, Belgium|51.22047,4.40026
  • Bruges, Belgium|51.20892,3.22424
  • Bruges, Belgium|51.20892,3.22424
  • Genk, Belgium|50.965,5.50082

Key Eligibility Criteria

  • Man with histologically confirmed prostate adenocarcinoma, initiating systemic therapy for metastatic disease, encompassing newly diagnosed (i.e. d…
  • 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

For full eligibility, visit ClinicalTrials.gov.

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