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New treatment option for Prostate Cancer (Adenocarcinoma)
Official title Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer
ClinicalTrials.gov ID: NCT06616597
What this study is testing
What is Abiraterone acetate?
Abiraterone acetate is an investigational medicine, being studied as a potential treatment for prostate cancer (adenocarcinoma).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.