Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse

PEACE 7 is an international, multicenter, randomized, open-label phase III study that aims at evaluating the efficacy and safety of darolutamide and of stereotactic dose escalated prostate radiotherapy in patients with localised prostate cancer and high-risk features of relapse (defined as patients with at least 2 high-risk criteria from National Comprehensive Cancer Network (NCCN) classification) using a factorial (2x2) design. The primary objective of this study is to assess the efficacy of darolutamide and of a stereotactic dose escalated radiotherapy targeting prostate in combination with

Trial Details

NCT ID
NCT06625970
Phase
PHASE3
Sponsor
UNICANCER
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Darolutamide
  • Stereotactic Body RadioTherapy (SBRT)
  • ADT (Standard of Care)
  • radiotherapy
Locations (sample)
  • Brest, France|48.39029,-4.48628
  • Dijon, France|47.31344,5.01391
  • Paris, France|48.85341,2.3488
  • Saint-Etienne, France|45.43389,4.39
  • Villejuif, France|48.7939,2.35992

Key Eligibility Criteria

  • Signed a written informed consent form prior to any trial specific procedures
  • Note: In case of physical incapacitation, a trusted representative of their choice, which is not the investigator or sponsor, can sign on the behal…
  • Men, 18 years ≤ Age ≤ 80 years
  • ECOG performance status of 0 or 1

For full eligibility, visit ClinicalTrials.gov.

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