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ACTIVE NOT RECRUITING
NCT04009967
PHASE2

Biomarkers for Neoadjuvant Pembrolizumab in Non-Metastatic Prostate Cancer Positive by 18FDG-PET Scanning

Sponsor: CHU de Quebec-Universite Laval

View on ClinicalTrials.gov

Summary

Various approaches are currently being developed for prostate cancer immunotherapy. However, a major challenge facing the development of cancer immunotherapy is the identification of tumors that would best respond to this type of treatment. Different studies suggest that prostate cancer more likely to progress are more infiltrated by exhausted T cells expressing the cell surface protein PD1 (Programmed cell death 1). Therefore, there is a strong rationale for selecting patients at higher risk of progression for testing the efficacy of anti-PD1 therapy. High glucose metabolism as detected by fludeoxyglucose F18 (FDG)-positron emission tomography (PET) (18FDG-PET) imagery is an innovative biological biomarker-based method to identify patients at higher risk of recurrence and early failure to hormonotherapy. Recent study demonstrated that high intra-prostatic 18-FDG-uptake was associated with higher Gleason grades. Therefore the one third of Gleason ≥ 8 prostate cancer patients with higher 18FDG uptake would be ideal candidates for early immunotherapy treatments based on anti-PD-1 such as pembrolizumab. The study aimed to identify biomarkers predictive the response to Pembrolizumab given prior to radical prostatectomy in participants with primary prostate cancer at high risk of progression.

Official 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)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2020-01-10

Completion Date

2025-03-30

Last Updated

2025-01-13

Healthy Volunteers

No

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg every three weeks for 3 cycles only

Locations (1)

CHU de Québec-Université Laval

Québec, Canada