Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer.

Prostate Cancer Clinical Trial

Official title: A Phase II Single Arm Study of Fecal Microbiota Transplant (FMT) in Men With Metastatic Castration Resistant Prostate Cancer Whose Cancer Has Not Responded to Enzalutamide + Pembrolizumab

Status Recruiting

Clinical Trial Summary

All patients will be required to have a biopsy of a metastatic tumor deposit at study entry. Pembrolizumab will be administered at a dose of 200 mg as a 30 minute IV infusion every 3 weeks. Enzalutamide will be continued at dose of 160 mg orally every day. Patients who have neither rapid disease progression or disease response will undergo a fecal microbiota transplant, have a second biopsy (if medically feasible), and be re-treated with pembrolizumab.

Clinical Trial Description

PRIMARY OBJECTIVE:

To determine the anticancer effect of fecal microbiota transplant from participants who respond to pembrolizumab into those who have not responded in metastatic castration resistant prostate cancer.

OUTLINE:

The investigators propose to study the effects of fecal microbiota transplant (FMT) in patients whose disease does not respond to treatment with the combination of pembrolizumab and enzalutamide. Patients will remain on enzalutamide throughout the study and be treated with pembrolizumab for 4 cycles. Their disease will be assessed by tumor imaging. Patients whose disease responds to treatment will become stool donors to non-responders. Non-responders will undergo a second biopsy (if medically feasible) and be re-treated with pembrolizumab. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostate Cancer Metastatic
• Prostatic Neoplasms

• NCT number: NCT04116775
• Study type: Interventional
• Source: Portland VA Medical Center
• Contact: Carmen Iben
• Phone: (503) 220-8262
• Email: iben@ohsu.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: October 30, 2019
• Completion date: October 2023