Informations générales (source: ClinicalTrials.gov)
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 of Relapse, From the Prostate Cancer Consortium in Europe (PEACE) (PEACE 7)
Interventional
Phase 3
UNICANCER (Voir sur ClinicalTrials)
avril 2025
octobre 2045
27 juin 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Pierre BLANCHARD, MD | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Lionel STAUDACHER, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges Francois Leclerc - Dijon - France | Magali QUIVRIN, MD | Contact (sur clinicalTrials) | |||
| CHU Saint-Etienne - Saint-Étienne - France | Thierry REYNAUD, MD | Contact (sur clinicalTrials) | |||
| Clinique Pasteur Lanroze - Brest - Brest - France | Ali HASBINI, MD | Contact (sur clinicalTrials) | |||
Critères
Homme
Inclusion Criteria:
1. 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 behalf of the patients
2. Men, 18 years ≤ Age ≤ 80 years
3. ECOG performance status of 0 or 1
4. No significant co-morbidities that might prevent long-term follow-up
5. Histologically confirmed adenocarcinoma of the prostate
6. Meet at least 2 of the following criteria from NCCN classification:
- Gleason score ≥8
- T3 or T4 disease (T3 defined by MRI is acceptable)
- Prostate-specific antigen ≥20 ng/mL
7. Prostate size on MRI <100 cc
8. Absolute neutrophil count ≥ 1.5 x 10⁹/L
9. Platelet count ≥100 x 10⁹/L
10. Haemoglobin ≥90 g/L (in absence of red blood cell transfusion within 4 weeks prior
to randomization)
11. 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
12. Creatinine ≤2.0 x ULN
13. Sexually active patients must agree to use an effective contraceptive method while
on treatment and for 1 week after the final dose of investigational product
14. Patient must be affiliated to a Social Security System or in possession of
equivalent private health insurance (according to local regulations for
participation in clinical trials)
15. Patient must be willing and able to comply with the protocol for the duration of the
trial including undergoing treatment and scheduled visits, and examinations
including follow-up
1. 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 behalf of the patients
2. Men, 18 years ≤ Age ≤ 80 years
3. ECOG performance status of 0 or 1
4. No significant co-morbidities that might prevent long-term follow-up
5. Histologically confirmed adenocarcinoma of the prostate
6. Meet at least 2 of the following criteria from NCCN classification:
- Gleason score ≥8
- T3 or T4 disease (T3 defined by MRI is acceptable)
- Prostate-specific antigen ≥20 ng/mL
7. Prostate size on MRI <100 cc
8. Absolute neutrophil count ≥ 1.5 x 10⁹/L
9. Platelet count ≥100 x 10⁹/L
10. Haemoglobin ≥90 g/L (in absence of red blood cell transfusion within 4 weeks prior
to randomization)
11. 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
12. Creatinine ≤2.0 x ULN
13. Sexually active patients must agree to use an effective contraceptive method while
on treatment and for 1 week after the final dose of investigational product
14. Patient must be affiliated to a Social Security System or in possession of
equivalent private health insurance (according to local regulations for
participation in clinical trials)
15. Patient must be willing and able to comply with the protocol for the duration of the
trial including undergoing treatment and scheduled visits, and examinations
including follow-up
1. 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 Note: Patients with infra-centimetric
nodal disease (<1 cm in small diameter) on conventional imaging and equivocal
hyperfixation on next generation imaging may be included
2. Recent history of TURP or prostate enucleation (less than 6 months) Note: patients
with severe obstructive symptoms (defined as International Prostate Symptom Score
(IPSS) ≥20) should be carefully evaluated to rule out the need for TURP/Prostate
enucleation
3. Prior treatment for prostate cancer, including prostatectomy, except lymph node
dissection (patients with PN- disease only can be accrued) or ADT (started more than
6 weeks before randomization)
4. Patient with other known concurrent severe and/or uncontrolled concurrent medical
disease or infection (such as active viral hepatitis, active human immunodeficiency
virus (HIV) or chronic liver disease) or co-morbidity, which could compromise
participation in the study
5. Cardiac disease such as uncontrolled hypertension (systolic BP ≥160 mmHg or
diastolic BP ≥95 mmHg; 3 consecutive measures taken 5 minutes apart), stroke,
congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease,
myocardial infarction within one year, coronary/peripheral artery bypass graft, LVEF
> grade 2
6. Uncontrolled diabetes mellitus
7. Current active hepatic or biliary disease (with exception of subjects with Gilbert's
syndrome, asymptomatic gallstones, stable chronic liver disease per investigator
assessment)
8. Gastrointestinal disorder or procedure, which expects to interfere significantly
with absorption of study treatment. Severe GI disorders precluding pelvic
irradiation
9. Known severely impaired lung function (spirometry and DLCO 70% or less of normal and
O2 saturation of 88% or less at rest on room air)
10. Other prior malignancy within the last 3 years, except basal cell skin cancer
11. Known hypersensitivity to the study treatment or any of its ingredients.
12. Physical or psychological condition or any condition that in the opinion of the
investigator would impair the patients' ability to comply with the study procedures
13. Previous treatment for prostate cancer (surgery or radiotherapy) or previous pelvic
irradiation that would make prostate/pelvis radiotherapy impossible
14. Concomitant prohibited treatment. Concurrent or planned treatment with strong
inhibitors or strong inducers of cytochrome P450 3A4/5. A one-week washout period is
necessary for patients who are already on these treatments
15. Prior treatment with second generation androgen receptor (AR) inhibitors, other
investigational AR inhibitors, or CYP17 enzyme inhibitor
16. Use of oestrogens or 5-α reductase inhibitors or AR inhibitors
17. Acute toxicities of prior treatments and procedures not resolved to grade ≤1 or
baseline before randomization
18. Prior chemotherapy or immunotherapy for prostate cancer
19. Major surgery within 28 days before randomization
20. Participation in another therapeutic trial within 30 days prior to inclusion
21. Persons deprived of their liberty or under protective custody or guardianship
22. Patients unwilling or unable to comply with the medical follow-up required by the
trial because of geographic, familial, social, or psychological reasons