OncoMatch/Clinical Trials/NCT06625970
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
Is NCT06625970 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Darolutamide and ADT (Standard of Care) for high risk prostate carcinoma.
Treatment: Darolutamide · ADT (Standard of Care) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Excluded: Stage IV, PELVIC LYMPH NODE METASTASIS
Clinically or radiologically detectable metastasis, including no evidence of pelvic lymph node metastasis on next generation imaging (PSMA PET/CT), nor enlarged pelvic lymph nodes (≥1 cm in small diameter) on MRI
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: prostatectomy
Exception: lymph node dissection (patients with PN- disease only can be accrued)
Prior treatment for prostate cancer, including prostatectomy, except lymph node dissection (patients with PN- disease only can be accrued)
Cannot have received: androgen deprivation therapy
Exception: ADT started more than 6 weeks before randomization
Prior treatment for prostate cancer, including ... ADT (started more than 6 weeks before randomization)
Cannot have received: second generation androgen receptor inhibitor
Prior treatment with second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor
Cannot have received: CYP17 enzyme inhibitor
Prior treatment with ... CYP17 enzyme inhibitor
Cannot have received: oestrogen
Use of oestrogens or 5-α reductase inhibitors or AR inhibitors
Cannot have received: 5-α reductase inhibitor
Use of oestrogens or 5-α reductase inhibitors or AR inhibitors
Cannot have received: androgen receptor inhibitor
Use of oestrogens or 5-α reductase inhibitors or AR inhibitors
Cannot have received: chemotherapy
Prior chemotherapy or immunotherapy for prostate cancer
Cannot have received: immunotherapy
Prior chemotherapy or immunotherapy for prostate cancer
Cannot have received: radiotherapy
Previous treatment for prostate cancer (surgery or radiotherapy) or previous pelvic irradiation that would make prostate/pelvis radiotherapy impossible
Cannot have received: pelvic irradiation
previous pelvic irradiation that would make prostate/pelvis radiotherapy impossible
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 x 10⁹/L; Platelet count ≥100 x 10⁹/L; Haemoglobin ≥90 g/L (in absence of red blood cell transfusion within 4 weeks prior to randomization)
Kidney function
Creatinine ≤2.0 x ULN
Liver function
ALT and/or AST ≤2.5 x ULN, total bilirubin ≤1.5 x ULN
Absolute neutrophil count ≥ 1.5 x 10⁹/L; Platelet count ≥100 x 10⁹/L; Haemoglobin ≥90 g/L (in absence of red blood cell transfusion within 4 weeks prior to randomization); Hepatic function: serum alanine aminotransferase (ALT) and/or aspartate transaminase (AST) ≤2.5 x upper limit of normal (ULN), total bilirubin ≤1.5 x ULN; Creatinine ≤2.0 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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