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Antiandrogen
Fecal microbiota transplant for Prostate Cancer
Phase 2
Recruiting
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
Study Summary
This trial will test whether combining immunotherapy with a fecal microbiota transplant will improve response rates in patients with metastatic cancer.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Anticancer effect of fecal microbiota transplant from responders to pembrolizumab to non-responders.
Secondary outcome measures
Characterization of safety profile
Overall survival
PSA progression-free survival
+6 moreSide effects data
From 2021 Phase 1 & 2 trial • 1 Patients • NCT03367910100%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
FMT for MDRO UTI
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
Enzalutamide
2014
Completed Phase 4
~2760
Fecal microbiota transplant
2018
Completed Phase 2
~10
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Julie Graff, MDLead Sponsor
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,748 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,898 Patients Enrolled for Prostate Cancer
Johns Hopkins UniversityOTHER
2,274 Previous Clinical Trials
14,840,485 Total Patients Enrolled
28 Trials studying Prostate Cancer
12,119 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a cancerous growth that can be safely examined through a tissue sample, and you are willing to undergo the biopsy.You can participate in the trial even if you have received treatment with sipuleucel-T, radium-223, or abiraterone before.You have had radiation therapy within the past two weeks before starting the study treatment.You have recently taken medication for your condition and have not fully recovered from any side effects.You have a history of seizures, unless you have had a brain tumor, like meningioma, removed.You currently have an autoimmune disease or have symptoms that may suggest one.You have factors that increase your risk of getting sick.You have other medical conditions related to your digestive system.You are taking drugs that weaken your immune system.You have a mental illness or struggle with drug addiction that may make it difficult for you to follow the study's requirements.You have severe bone pain or other symptoms related to your disease that require immediate chemotherapy.You must stop taking all treatments for metastatic castration-resistant prostate cancer (mCRPC) except for enzalutamide and a GnRH agent for a certain amount of time before participating in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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