Study on Targeting Gut Bacteria to Overcome Resistance to Abiraterone in Metastatic Prostate Cancer

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60

ClinicalTrials ID:NCT06616597

Provider View

This clinical trial is exploring whether adding dexamethasone, with or without metronidazole, can help restore the effectiveness of abiraterone in treating metastatic prostate cancer that has become resistant to this medication.

Patient Parameters

Program Overview

The study aims to find out if using dexamethasone, alone or with metronidazole, can make abiraterone work again for patients with metastatic prostate cancer that no longer responds to this treatment. Abiraterone is usually given when the first treatment option stops working, but over time, some cancers become resistant to it. Researchers believe that bacteria in the gut might be producing substances that cause this resistance. This study focuses on the gut bacteria as a possible reason for the resistance to abiraterone.

Description

This trial is testing whether adding dexamethasone, with or without metronidazole, to abiraterone can help patients with metastatic castration-resistant prostate cancer (mCRPC) who have stopped responding to abiraterone. Abiraterone, along with prednisone, is used when the initial hormone therapy fails, but resistance can develop. The exact reason for this resistance is unclear, but it might be linked to androgen production by gut bacteria. This study investigates the role of the gut microbiome in causing resistance to abiraterone in mCRPC.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 and older.
  • Diagnosed with prostate adenocarcinoma.
  • PSA level of 2.0 ng/mL or higher at screening.
  • Cancer progression after at least 12 weeks on abiraterone and prednisone.
  • Must be on a GnRH analogue or have had an orchiectomy.
  • Expected to live at least 6 more months.
  • Able to swallow tablets.
  • Willing to avoid alcohol during and for 14 days after metronidazole treatment.
  • Willing to provide urine and stool samples as required by the study.

Exclusion Criteria

  • Active infection or medical condition that makes dexamethasone unsafe.
  • Need for high-dose corticosteroids for another condition.
  • Small cell carcinoma of the prostate.
  • Spinal cord compression based on clinical findings or MRI.
  • Severe liver disease (Child-Pugh class C cirrhosis).
  • High bilirubin or liver enzymes.
  • Heart rhythm issues (prolonged QTc syndrome).
  • Pituitary or adrenal gland problems.
  • Uncontrolled diabetes or recent increase in insulin dosage.
  • Recent participation in another drug study or invasive procedure.
  • Serious illness or condition that makes the study too risky, including:
    • Uncontrolled major infection.
    • Crohn's disease or ulcerative colitis.
    • Toxic megacolon or small bowel blockage.
    • Allergy to study drugs.
  • Recent antibacterial treatment.
  • Any condition that poses a risk or interferes with study participation.

Locations

FACILITYZIPCITYSTATE
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins21231BaltimoreMaryland

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