Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

This Investigator-initiated, Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) study will be conducted in subjects with high-risk localized or locally advanced prostate cancer (PCa). The study contains both a randomized Phase 3 treatment intensification study, as well as a treatment de-intensification non-randomized Phase 2 study. The aim of the THUNDER study is to improve the outcome of high-risk PCa by improved risk stratification. Novel radiotracers and a genomic classifier (Decipher) will be used to guide treatment decisions, instead o

Trial Details

NCT ID
NCT06282588
Phase
PHASE2 / PHASE3
Sponsor
Cancer Research Antwerp
Status
RECRUITING
Cancer Type
Hormone-Sensitive Prostate Cancer
Interventions
  • Darolutamide
  • Darolutamide matched placebo
  • Radiotherapy
  • Zoladex 3.6Mg Implant
  • Zoladex LA
  • Decapeptyl sustained release 22.5 mg
Locations (sample)
  • Wilrijk, Antwerp, Belgium|51.16734,4.39513
  • Aalst, Belgium|50.93604,4.0355
  • Bruges, Belgium|51.20892,3.22424
  • Brussels, Belgium|50.85045,4.34878
  • Ghent, Belgium|51.05,3.71667

Key Eligibility Criteria

  • Histopathology-proven PCa
  • High-risk locally advanced disease is defined as any of the following factors: PSA \> 20 ng/mL OR T-stage 3 or 4 OR Gleason score 8-10 OR cN1.
  • Note: documentation of the clinical T-stage may be obtained from any clinical assessment acceptable for clinical T staging including physical exam …
  • An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Hormone-Sensitive Prostate Cancer Trials on Trialify →