2023-509787-15-00招募中3 期
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).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Unicancer
- 入组人数
- 450
- 试验地点
- 43
- 主要终点
- Metastasis-free survival (MFS)
研究概览
简要总结
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), in patients with localised prostate cancer and high-risk features of relapse (defined as patients having at least 2 high-risk criteria from the NCCN classification) in a 2 by 2-factorial trial.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Signed a written informed consent form prior to any trial specific procedures
- •Haemoglobin ≥ 90 g/L (in absence of red blood cell transfusion within 4 weeks prior to randomisation)
- •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
- •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
- •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)
- •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
- •Men, 18 years ≤ Age ≤ 80 years
- •ECOG performance status of 0 or 1
- •No significant co-morbidities that might prevent long-term follow-up
- •Histologically confirmed adenocarcinoma of the prostate
- •Meet at least 2 of the following criteria from NCCN classification
- •Prostate size on MRI < 100 cc
- •Absolute neutrophil count ≥ 1.5 x 10^9/L
- •Platelet count ≥ 100 x 10^9/L
排除标准
- •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.
- •Other prior malignancies within the last 3 years, except basal cell skin cancer
- •Known hypersensitivity to the study treatment or any of its ingredients
- •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
- •Previous treatment for prostate cancer (surgery or radiotherapy) or previous pelvic irradiation that would make prostate/pelvis radiotherapy impossible
- •Concomitant prohibited treatment. Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/
- •A one-week washout period is necessary for patients who are already on these treatments
- •Prior treatment with second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP17 enzyme inhibitor
- •Use of oestrogens or 5-α reductase inhibitors or AR inhibitors
- •Acute toxicities of prior treatments and procedures not resolved to grade ≤ 1 or baseline before randomisation.
- •Prior chemotherapy or immunotherapy for prostate cancer.
- •Major surgery within 28 days before randomisation
- •Recent history of TURP or prostate enucleation (less than 6 months)
- •Participation in another therapeutic trial within 30 days prior to inclusion
- •Persons deprived of their liberty or under protective custody or guardianship
- •Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons
- •Prior treatment for prostate cancer except lymph node dissection (i.e. patients with PN- disease only can be included) or ADT (started more than 6 weeks before randomisation).
- •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.
- •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,
- •Uncontrolled diabetes mellitus
- •Current active hepatic or biliary disease (with exception of subjects with Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease per investigator assessment)
- •Gastrointestinal disorder or procedure, which expects to interfere significantly with absorption of study treatment. Severe GI disorders precluding pelvic irradiation
- •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)
结局指标
主要结局
Metastasis-free survival (MFS)
Metastasis-free survival (MFS)
次要结局
- 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
研究者
Director of Regulatory Affairs,Pharmacovigilance and Quality Insurance
Scientific
Unicancer
研究点 (43)
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