High-risk prostate cancer MedDRA version: 21.1 Level: LLT Classification code 10026389 Term: Malignant neoplasm of prostate System Organ Class: 100000004864
Conditions
Interventions
Trade Name: KEYTRUDA (pembrolizumab, MK 3475)
Product Name: KEYTRUDA (pembrolizumab, MK 3475)
Product Code: [MK 3475]
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Pembrolizumab
CAS
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of prostate cancer 2. PCa detected at prostate biopsy with a risk of lymph node invasion higher than 5% according to the Briganti nomogram 3. The participant should be fit and planned for RP and ePLND 4. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial 5. Did not start novel therapies within the 4 weeks before the beginning of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 59 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Has received prior systemic anti-cancer therapy including investigational agents prior to allocation. 2. Unable to complete the diagnostic investigations required per protocol 3. Evidence of metastases at preoperative imaging 4. Evidence of lymph node invasion before surgery 5. Life expectancy shorter than 12 months 6. History of chemotherapy 7. History of brachytherapy or EBRT 8. Cardiovascular diseases not controlled by medical therapy 9. Hearth failure 10. Clinically relevant hepatic or renal diseases 11. Onset of cerebral diseases within 6 months before the study beginning 12. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if neoadjuvant therapy with pembrolizumab is associated with pathologic changes at radical prostatectomy and with a reduction in the rate of lymph node invasion in prostate cancer patients at high risk of recurrence after surgery.;Secondary Objective: - To evaluate radiological response in terms of reduction of tumour volume at preoperative mpMRI on those patients with measurable disease at baseline. Radiological response will be defined as a tumour reduction of 30% in the maximum diameter of the index lesion as measured by mpMRI - To test the impact of neoadjuvant pembrolizumab on the risk positive surgical margins at final pathology - To test the impact of neoadjuvant pembrolizumab on the risk of PSA persistence after surgery - To assess the safety and side effects of pembrolizumab in PCa patients undergoing surgery;Primary end point(s): 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%);Timepoint(s) of evaluation of this end point: Pathologic assessment of surgical specimens (within 4 weeks after surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Positive margins, PSA persistence after surgery,;Timepoint(s) of evaluation of this end point: Up to 2 years after radical prostatectomy | — |
Countries
Italy
Contacts
Public ContactUnità Operativa di Urologia
IRCCS Ospedale San Raffaele
Outcome results
None listed