RECRUITING

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

Conditions

Prostate Cancer (Adenocarcinoma)Metastatic Prostate Cancer Abiraterone microbiome Dexamethasone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02-13

Study Completion:2032-03-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06616597

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Irina Rifkind, RN

CONTACT

410-502-2043

Irifkin1@jhmi.edu

Yelena Milman

CONTACT

410-955-1865

ymilman1@jhmi.edu

Principal Investigator

Catherine Handy-Marshall, M.D.

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Catherine Handy-Marshall, M.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-13

Study Completion Date2032-03-30

Study Record Updates

Study Start Date2025-02-13

Study Completion Date2032-03-30

Terms related to this study

Keywords Provided by Researchers

Abiraterone
microbiome
Dexamethasone

Additional Relevant MeSH Terms

Prostate Cancer (Adenocarcinoma)
Metastatic Prostate Cancer