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A study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in patients affected by high-risk prostate cancer
EU CTIS ID: 2024-514580-26-00
What this study is testing
To assess if neoadjuvant therapy with pembrolizumab is associated with a reduction in the rate of lymph node invasion in prostate cancer patients at high risk of recurrence after surgery.
- 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
- Male participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of prostate cancer
- PCa detected at prostate biopsy with a risk of lymph node invasion higher than 5% according to the Briganti nomogram
- The participant should be fit and planned for RP and ePLND
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
- Did not start novel therapies within the 4 weeks before the beginning of the study
- Willingness to use contraception during study treatment
You likely can't join if
- Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
- Clinically relevant hepatic or renal diseases
- Onset of cerebral diseases within 6 months before the study beginning
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Severe hypersensitivity (Grade 3) to pembrolizumab and/or any of its excipients
- Unable to complete the diagnostic investigations required per protocol
See the full eligibility criteria
- Male participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of prostate cancer
- PCa detected at prostate biopsy with a risk of lymph node invasion higher than 5% according to the Briganti nomogram
- The participant should be fit and planned for RP and ePLND
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial
- Did not start novel therapies within the 4 weeks before the beginning of the study
- Willingness to use contraception during study treatment
- Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
- Clinically relevant hepatic or renal diseases
- Onset of cerebral diseases within 6 months before the study beginning
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Severe hypersensitivity (Grade 3) to pembrolizumab and/or any of its excipients
- Unable to complete the diagnostic investigations required per protocol
- Evidence of metastases at preoperative imaging
- Evidence of lymph node invasion before surgery
- Life expectancy shorter than 12 months
- History of chemotherapy
- History of brachytherapy or EBRT
- Cardiovascular diseases not controlled by medical therapy
- Hearth failure
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.