A study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in patients affected by high-risk prostate cancer
Key facts
- Where
- Milan, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- Ospedale San Raffaele S.r.l.Milan, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ospedale San Raffaele S.r.l.
- Trial code
- EU 2024-514580-26-00
- Record updated
- 2024. október 8.
- Original description
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.Read full original descriptionShow less
An open label, single-arm, phase 2 study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in high-risk prostate cancer patients
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.
Inclusion: 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.
Exclusion: 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; 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; 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; Unable to complete the diagnostic investigations required per protocol; Evidence of metastases at preoperative imaging; Life expectancy shorter than 12 months.