An open label, single-arm, phase 2 study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in high-risk prostate cancer patients

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514580-26-00

Enrollment

Registered

2024-10-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk prostate cancer

Brief summary

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%)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUG[68GA]PSMA-HBED-CC

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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%)	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026