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PEACE 7 : A randomized Phase III trial with a factorial design evaluating the efficacy and safety of darolutamide and stereotactic dose escalated radiotherapy in patients with localized prostate cancer and high-risk features ofrelapse, from the Prostate Cancer Consortium in Europe (PEACE).

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509787-15-00
Acronym
UC-GTG-2310
Enrollment
450
Registered
2024-05-27
Start date
2025-02-17
Completion date
Unknown
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with localised prostate cancer and high-risk features of relapse (minimum 2 high-risk criteria from National Comprehensive Cancer Network (NCCN) classification)1 and with no detectable metastasis, including no evidence of pelvic lymph node metastasis on next-generation imaging (PSMA PET/CT).

Brief summary

Metastasis-free survival (MFS)

Detailed description

Clinical Progression-Free Survival (cPFS), Biochemical Progression-Free Survival, Time to local relapse, Overall Survival (OS), Prostate Cancer-Specific Survival (PCSS), Severity of the adverse events and toxicities, Long-term toxicity, Quality of Life

Interventions

DRUGTRIPTORELIN

Sponsors

Unicancer
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Metastasis-free survival (MFS)

Secondary

MeasureTime frame
Clinical Progression-Free Survival (cPFS), Biochemical Progression-Free Survival, Time to local relapse, Overall Survival (OS), Prostate Cancer-Specific Survival (PCSS), Severity of the adverse events and toxicities, Long-term toxicity, Quality of Life

Countries

France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026