BridgeMD
Prostate Androgen Response Investigation using a Stratification BIOmarker - PARIS-BIO
EU CTIS ID: 2025-520639-17-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must be >= 18 years of age
- A clinically relevant Prostate MRI
- 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
You likely can't join if
- ≥M1 or ≥N2
- 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
See the full eligibility criteria
- Patients must be >= 18 years of age
- A clinically relevant Prostate MRI
- 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.
- ≥M1 or ≥N2
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.