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

Phase 1

• Conditions: High-risk prostate cancer; MedDRA version: 21.1Level: LLTClassification code 10026389Term: Malignant neoplasm of prostateSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2019-004782-40-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 59

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified