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Corticosteroid

Metronidazole + Abiraterone + Dexamethasone for Prostate Cancer

Phase 2
Waitlist Available
Led By Catherine Handy-Marshall, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with prostate adenocarcinoma
Males aged 18 years of age and above
Must not have
Pathological finding consistent with small cell carcinoma of the prostate
Chronic liver disease with Child-Pugh class C cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to find out if adding metronidazole to dexamethasone can help make abiraterone more effective in treating metastatic prostate cancer."

Who is the study for?
This trial is for men with metastatic prostate cancer who have become resistant to abiraterone treatment. Specific eligibility criteria are not provided, but typically participants would need to be in good health otherwise and meet certain medical standards set by the study.
What is being tested?
The study is testing if adding dexamethasone alone or in combination with metronidazole can make abiraterone effective again for treating metastatic prostate cancer. It's a Phase II trial, which means it's looking at effectiveness and side effects.
What are the potential side effects?
Possible side effects may include digestive issues from metronidazole, immune system changes due to dexamethasone, and the known side effects of abiraterone such as fatigue, joint pain, and high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate cancer.
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I am a man aged 18 or older.
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My prostate cancer worsened after 12 weeks on abiraterone and prednisone.
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I can swallow pills.
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I am on hormone therapy or have had surgery to remove my testicles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My prostate cancer is diagnosed as small cell carcinoma.
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I have severe liver disease (Child-Pugh class C).
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I have had issues with my pituitary or adrenal glands.
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I do not have major infections, Crohn's disease, ulcerative colitis, toxic megacolon, small bowel ileus, or allergies to the compounds being studied.
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I have or am at risk of having pressure on my spinal cord, confirmed by symptoms or MRI.
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I do not have any infections or conditions that prevent me from using dexamethasone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with PSA30 response
Secondary study objectives
Number of grade 3-5 toxicities
Number of participants with PSA50 response
Number of participants with progression
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Abiraterone + Dexamethasone + metronidazoleExperimental Treatment3 Interventions
Abiraterone acetate plus dexamethasone plus metronidazole
Group II: Arm 1: Abiraterone + DexamethasoneExperimental Treatment2 Interventions
Abiraterone acetate plus dexamethasone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metronidazole
2011
Completed Phase 4
~3810
Dexamethasone
2007
Completed Phase 4
~2650
Abiraterone acetate
2014
Completed Phase 3
~3440

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,322 Total Patients Enrolled
58 Trials studying Prostate Cancer
3,428 Patients Enrolled for Prostate Cancer
Catherine Handy-Marshall, M.D.Principal InvestigatorJohns Hopkins University
~39 spots leftby Dec 2030
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