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Trial Title:
Phase II Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
NCT ID:
NCT06616597
Condition:
Prostate Cancer (Adenocarcinoma)
Metastatic Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Metronidazole
Dexamethasone
Abiraterone Acetate
Conditions: Keywords:
Abiraterone
microbiome
Dexamethasone
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Abiraterone acetate
Description:
Abiraterone acetate 1000mg/ day
Arm group label:
Arm 1: Abiraterone + Dexamethasone
Arm group label:
Arm 2: Abiraterone + Dexamethasone + metronidazole
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Dexamethasone 0.5mg/day
Arm group label:
Arm 1: Abiraterone + Dexamethasone
Arm group label:
Arm 2: Abiraterone + Dexamethasone + metronidazole
Intervention type:
Drug
Intervention name:
Metronidazole
Description:
Metronidazole 1500mg/ per day
Arm group label:
Arm 2: Abiraterone + Dexamethasone + metronidazole
Other name:
Flagyl
Summary:
To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to
abiraterone for the treatment of metastatic prostate cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Males aged 18 years of age and above.
- Prostate adenocarcinoma
- Absolute PSA ≥ 2.0 ng/mL at screening.
- PSA (+/- radiographic) progression after having been on abiraterone and prednisone
for at least 12 weeks.
- Must be maintained on a GnRH analogue or have undergone orchiectomy.
- Participants must have a life expectancy ≥ 6 months
- Ability to swallow study medication tablets
- Willing to abstain from alcohol during and for 14 days after treatment with
metronidazole
- Willing and able to collect urine and stool samples per protocol
Exclusion Criteria:
- Active infection or other medical condition that would make dexamethasone use
contraindicated
- Any chronic medical condition requiring a higher systemic dose of corticosteroid
- Pathological finding consistent with small cell carcinoma of the prostate
- Has imminent or established spinal cord compression based on clinical findings
and/or MRI.
- Chronic liver disease with Child-Pugh class C cirrhosis (see calculator in protocol)
- Bilirubin >3x ULN or AST and ALT >5x ULN
- Congenital prolonged QTc syndrome or QTc > 500 msec (non-paced rhythm)
- History of pituitary or adrenal dysfunction
- Uncontrolled diabetes (Hemoglobin A1c > 10%) or increasing doses of insulin
within the past 4 weeks due to poorly controlled glucoses.
- Administration of an investigational therapeutic or invasive surgical procedure (not
including surgical castration) within 30 days of Cycle 1 Day 1 or currently enrolled
in an investigational drug study
- Any other serious illness or medical condition that would, in the opinion of the
investigator, make this protocol unreasonably hazardous, including, but not limited
to:
- Any uncontrolled major infection.
- Crohn's disease or ulcerative colitis.
- Known or suspected toxic megacolon and/or known small bowel ileus.
- Known allergy to any of the compounds under investigation.
- On antibacterial therapy within 30 days prior to administration of study treatment.
- Any condition or situation which, in the opinion of the investigator, would put the
subject at risk, or interfere with the subject's participation in this study.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sibley Memorial Hospital
Address:
City:
Washington
Zip:
20016
Country:
United States
Contact:
Last name:
Layla Seward, RN
Phone:
202-660-6500
Email:
lseward1@jhmi.edu
Facility:
Name:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21231
Country:
United States
Contact:
Last name:
Irina Rifkind, RN
Phone:
410-502-2043
Email:
Irifkin1@jhmi.edu
Start date:
December 30, 2024
Completion date:
December 30, 2030
Lead sponsor:
Agency:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency class:
Other
Source:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06616597
