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Antiandrogen

Fecal microbiota transplant for Prostate Cancer

Phase 2

Waitlist Available

Led By Julie N Graff, MD

Research Sponsored by Julie Graff, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from 12 weeks up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a combination of immunotherapy, hormone-blocking pills, and stool transplants can help treat advanced prostate cancer that doesn't respond to standard treatments.

Eligible Conditions

Prostate Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 12 weeks up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 12 weeks up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 12 weeks up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Anticancer effect of fecal microbiota transplant from responders to pembrolizumab to non-responders.

Secondary study objectives

Characterization of safety profile

Overall survival

PSA progression-free survival

+6 more

Side effects data

From 2021 Phase 1 & 2 trial • 1 Patients • NCT03367910

100%

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

FMT for MDRO UTI

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment3 Interventions

INITIAL TREATMENT PHASE: Patients progressing on enzalutamide will receive 200 mg of pembrolizumab IV over 30 minutes. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily and androgen deprivation therapy. ASSESSMENT PHASE: After completion of the initial treatment phase, patients will have their disease assessed by tumor imaging. Patients who respond to treatment will become stool donors to patients who do not respond. Non-responders will move on to the retreatment phase. RETREATMENT PHASE: Non-responders will undergo a fecal transplant and be retreated with 200 mg of pembrolizumab IV over 30 minutes. Treatment repeats every 3 weeks for an additional 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily and androgen deprivation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal microbiota transplant

2018

Completed Phase 2

~10

Enzalutamide

2014

Completed Phase 4

~3820