Study Title

Phase II Clinical and Translational Study of Neoadjuvant Pembrolizumab Before Radical Prostatectomy in Non-metastatic Gleason ≥8 Prostate Cancer Patients Positive by 18FDG-PET Scanning ( PICT-01)

Study Details

Description:

This is a Phase II, single-arm and open-label trial of pembrolizumab (MK-3475) in localized prostate cancer patients with newly diagnosed non-metastatic prostate cancer (Gleason grade ≥8 on biopsy) with positive tumor by FDG-PET (SUV max >4) who chose to undergo radical prostatectomy and lymph node dissection as primary treatment. The trial will meet its endpoint if a reduction in cancer extent, proliferative index and increased apoptosis, as well as an induction of favorable immune cell infiltration and immune checkpoint expression profiles are observed after treatment compare to baseline.

Sponsor:

CHU de Quebec-Universite Laval

Contacts:

Alain Bergeron, Ph.D

alain.bergeron@crchudequebec.ulaval.ca

418-525-4444 ext 15530

Marjorie Besançon, Ph.D

marjorie.besancon@crchudequebec.ulaval.ca

418-525-4444 ext 20417

Yves Fradet, MD (Principal Investigator)

yves.fradet@crchudequebec.ulaval.ca

418 525-4444 ext 15555