Condition: High Risk Prostate Carcinoma · Prostate Cancer · Sponsor: UNICANCER
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 ADT and pelvic nodal radiotherapy in terms of metastasis-free survival (MSF). Patients will be randomized (1:1:1:1) to receive either: * Arm A (Standard arm): ADT + conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy * Arm B (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated prostate radiotherapy including pelvic nodal radiotherapy + darolutamide * Arm C (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy + Prostate SBRT * Arm D (Experimental arm): ADT + conventional fractionated or moderately hypo-fractionated pelvic nodal radiotherapy + Prostate SBRT + darolutamide Patient will receive systemic treatments (ADT and/or darolutamide) during 2 years where visits on site are planned at D45, D90, D180 and then every 3 months for checku…
This description comes directly from the study's public registry record.
Carine LA · 014-423-0404 · c-la@unicancer.fr
Catherine LEGER · c-leger@unicancer.fr
Always discuss trial participation with your own doctor first.
| Clinique Pasteur Lanroze - Brest | Brest, France | Recruiting |
| Centre Georges Francois Leclerc | Dijon, France | Recruiting |
| Groupe Hospitalier Paris Saint-Joseph | Paris, France | Recruiting |
| CHU Saint-Etienne | Saint-Etienne, France | Recruiting |
| Gustave Roussy, Cancer Campus, Grand Paris | Villejuif, France | Recruiting |
| CHU Martinique | Fort-de-France, Martinique | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06625970