2025-520639-17-00招募中2 期
Prostate Androgen Response Investigation using a Stratification BIOmarker - PARIS-BIO Predicting prostate cancer downstageing by neoadjuvant Darolutamide with PCAI ImmunoScore in a non-randomised open label prospective trial.
Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Association of pathological response (MRD) with the pre-treatment genomic biomarker PCAI ImmunoScore
研究概览
简要总结
To retrospectively assess the predictive value of the pre-treatment genomic biomarker PCAI ImmunoScore for pathologic minimal residual disease (MRD) in patients undergoing neoadjuvant Darolutamide treatment before radical prostatectomy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must be >= 18 years of age
- •A clinical Prostate MRI, not older than 3 months at the time of screening
- •Biopsy confirmed high-risk prostate cancer defined as a global ISUP-score ≥4 with any MRI PIRADS score or global ISUP=3 with any MRI PIRADS score =5
- •Candidate for radical prostatectomy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- •Able to receive Darolutamide for 90-120 days
- •Signed informed consent form
- •A participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 1 week after last dose of Darolutamide except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation) or use a highly effective method of contraception (< 1% documented failure rate).
- •Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.
排除标准
- •Prior treatment with androgen receptor antagonists
- •Treatment with gonadotropin-releasing hormone (GnRH)
- •History of prior systemic or local therapy for prostate cancer, including pelvic radiation to the prostate
- •Major surgery <=4 weeks prior to inclusion
结局指标
主要结局
Association of pathological response (MRD) with the pre-treatment genomic biomarker PCAI ImmunoScore
Association of pathological response (MRD) with the pre-treatment genomic biomarker PCAI ImmunoScore
次要结局
- The associaton of the PCAI ImmunoScore with pathologic complete response (pCR)
- The associaton of the PCAI ImmunoScore with pT-stage at final pathology
- The associaton of the PCAI ImmunoScore with size of largest cross-sectional dimension of residual tumour on pathology
- The associaton of the PCAI ImmunoScore with number of resection specimen slides in which the tumour can be seen on pathology
- The associaton of the PCAI ImmunoScore with MRI assessment of changes in tumour size, cross sectional dimension, volume, and EPE
- The associaton of the PCAI ImmunoScore with blood PSA concentration during treatment
- Correlation between Pathological response and MRI response.
- Hormonal side effects during and after treatment, measured through AE/SAE registration and repeated validated questionnaires as well as changes in blood testosterone concentration
- Post- surgical functional outcomes (erectile function and urinary continence) in the cohort measured through questionnaires
研究者
Peter Wiklund
Scientific
Karolinska University Hospital
研究点 (2)
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