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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 checkups and follow prostate specific antigen (PSA) level. Metastasis-free survival (MFS) is defined as the time interval from randomization to the date of the appearance of metastasis (on next generation imaging) or death (from any cause), whichever occurs first. Radiographic evaluation will be carried out at the time of biochemical failure (Phoenix criteria) or in case of clinical suspicion. After biochemical failure (Phoenix criteria) radiographic evaluation on next generation imaging (prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan (any European Medicines Agency (EMA) approved PSMA tracer)) will be performed every 6 months until a metastatic site of relapse is identified and will be repeated at each subsequent PSA progression.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wyrażenie zgody na udział w badaniu.
- •Mężczyźni w wieku 18-80 lat.
- •Stan ogólny dobry (sprawność według skali ECOG 0 lub 1).
- •Brak poważnych chorób współistniejących, które mogłyby przeszkadzać w długoterminowej obserwacji.
- •Potwierdzony histologicznie rak gruczołu krokowego.
- •Spełnianie co najmniej 2 z poniższych kryteriów ryzyka nawrotu: wynik Gleasona ≥8, choroba T3 lub T4, poziom PSA ≥20 ng/mL.
- •Rozmiar prostaty na rezonansie magnetycznym <100 cc.
- •Dobra funkcja nerek i wątroby.
✗ Disqualifies
- •Stwierdzone przerzuty raka ani powiększone węzły chłonne w miednicy (widoczne w badaniach obrazowych).
- •Inne poważne choroby, które mogłyby wpłynąć na bezpieczeństwo lub wyniki badania.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Last updated (source)
- July 31, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (6)
Clinique Pasteur Lanroze - Brest
Brest, France
Centre Georges Francois Leclerc
Dijon, France
Groupe Hospitalier Paris Saint-Joseph
Paris, France
CHU Saint-Etienne
Saint-Etienne, France
Gustave Roussy, Cancer Campus, Grand Paris
Villejuif, France
CHU Martinique
Fort-de-France, Martinique
Trial contact
Carine LA
Catherine LEGER
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/1/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.