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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06616597
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Prostate Cancer
  • Prostate Cancer (Adenocarcinoma)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abiraterone acetate — DRUG
    Abiraterone acetate 1000mg/ day
  • Dexamethasone — DRUG
    Dexamethasone 0.5mg/day
  • Metronidazole — DRUG
    Metronidazole 1500mg/ per day

Study Details

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

Key Dates

Start date
Feb 13, 2025
Status verified
Feb 2026
Primary completion
Mar 30, 2031
Completion
Mar 30, 2032

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Abiraterone + Dexamethasone
    Abiraterone acetate plus dexamethasone
  • Experimental: Arm 2: Abiraterone + Dexamethasone + metronidazole
    Abiraterone acetate plus dexamethasone plus metronidazole

Primary Outcome Measure

Number of participants with PSA30 response [ Time Frame: 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21231
Irina Rifkind, RN
[email protected]
410-502-2043

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