NCT04116775

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Julie Graff, MD · Federal
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Cancer
• Prostate Cancer Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	Fecal microbiota transplant	A total of 100 mL of a mixture of stool and saline will be transplanted via endoscopy once.
DRUG	Pembrolizumab	Pembrolizumab 200 mg administered as a 30 minute infusion every 3 weeks.
DRUG	Enzalutamide	Daily oral dose.

Timeline

• Start date: 2019-10-30
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2019-10-07
• Last updated: 2022-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study