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Clinical Trial Protocol for ProBio-mHSPC: A ctDNA-driven De-escalation and Intensification Platform Trial for

Bram De Laere1, Alessio Crippa2, Andrea Discacciati2

  • 1Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Department of Human Structure and Repair Ghent University, Ghent, Belgium.

European Urology Focus
|May 11, 2026
PubMed

Insights

This study investigates using circulating tumor DNA (ctDNA) to personalize prostate cancer treatment. It aims to reduce therapy for patients with undetectable ctDNA while intensifying treatment for those with detectable ctDNA, improving quality of life.

Area of Science:

  • Oncology
  • Genomics
  • Translational Medicine

Background:

  • Metastatic hormone-sensitive prostate cancer (mHSPC) requires effective first-line treatments.
  • Current treatment strategies may lead to significant toxicity and reduced quality of life.
  • Personalized medicine approaches are needed to optimize treatment outcomes.

Purpose of the Study:

  • To evaluate the utility of circulating tumor DNA (ctDNA) in guiding first-line therapy for mHSPC.
  • To determine if ctDNA can enable safe de-escalation of treatment in patients with undetectable ctDNA.
  • To assess if ctDNA can guide intensified, biomarker-matched treatment in patients with detectable ctDNA.

Main Methods:

  • Prospective clinical trial design.
  • Utilizing ctDNA analysis to stratify patients based on disease detectability.
  • Comparing outcomes, toxicity, and quality of life between treatment arms guided by ctDNA status.

Main Results:

  • [Results pending publication]
  • [Results pending publication]
  • [Results pending publication]

Conclusions:

  • [Conclusions pending publication]
  • [Conclusions pending publication]
  • [Conclusions pending publication]

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