A study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in patients affected by high-risk prostate cancer

Prior treatment

• Has received prior systemic anti-cancer therapy including investigational agents prior to allocation.
• Onset of cerebral diseases within 6 months before the study beginning
• Evidence of lymph node invasion before surgery

Other illness

• Clinically relevant hepatic or renal diseases
• Severe hypersensitivity (Grade 3) to pembrolizumab and/or any of its excipients
• History of chemotherapy
• History of brachytherapy or EBRT
• Cardiovascular diseases not controlled by medical therapy
• Hearth failure

Lab values

• 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

Other

• Unable to complete the diagnostic investigations required per protocol
• Evidence of metastases at preoperative imaging
• Life expectancy shorter than 12 months

• 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