2024-514580-26-00
Not yet recruiting
Phase 2
An open label, single-arm, phase 2 study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in high-risk prostate cancer patients
Ospedale San Raffaele S.r.l.1 site in 1 country59 target enrollmentOctober 8, 2024
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ospedale San Raffaele S.r.l.
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- A reduction of 50% in the rate of node positive patients compared to what currently reported in the literature represents the main endpoint of the study (rate of pN0 of 85 vs. 70%)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Francesco Montorsi
Scientific
Ospedale San Raffaele S.r.l.
Eligibility Criteria
Inclusion 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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
A reduction of 50% in the rate of node positive patients compared to what currently reported in the literature represents the main endpoint of the study (rate of pN0 of 85 vs. 70%)
A reduction of 50% in the rate of node positive patients compared to what currently reported in the literature represents the main endpoint of the study (rate of pN0 of 85 vs. 70%)
Study Sites (1)
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