Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06616597

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-02-19

58

Participants Needed

1

Research Sites

371 weeks

Total Duration

On this page

Sponsors

S

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.

CONDITIONS

Official Title

Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 years or older
  • Diagnosed with prostate adenocarcinoma
  • PSA level of at least 2.0 ng/mL at screening
  • Evidence of PSA or radiographic progression after at least 12 weeks on abiraterone and prednisone
  • Must be on a GnRH analogue or have had orchiectomy
  • Life expectancy of at least 6 months
  • Ability to swallow study medication tablets
  • Willing to abstain from alcohol during and for 14 days after metronidazole treatment
  • Willing and able to collect urine and stool samples as required by the study protocol
Not Eligible

You will not qualify if you...

  • Active infection or medical condition making dexamethasone use unsafe
  • Chronic condition requiring higher doses of corticosteroids
  • Small cell carcinoma of the prostate
  • Imminent or confirmed spinal cord compression
  • Chronic liver disease with Child-Pugh class C cirrhosis
  • High bilirubin or liver enzyme levels (bilirubin >3x ULN, AST/ALT >5x ULN)
  • Congenital prolonged QTc syndrome or QTc > 500 msec without pacemaker
  • History of pituitary or adrenal dysfunction
  • Uncontrolled diabetes (HbA1c > 10%) or recent increasing insulin doses
  • Use of investigational therapy or invasive surgery within 30 days before start
  • Serious illness or conditions making study participation unsafe, including uncontrolled major infection, Crohn's disease, ulcerative colitis, toxic megacolon, small bowel ileus, or allergy to study drugs
  • Use of antibacterial therapy within 30 days before treatment
  • Any other condition considered unsafe or interfering with participation by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States, 21231

Actively Recruiting

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Research Team

D

Donna Bieg, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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