Search / Trial NCT06616597

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

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Sep 26, 2024

Trial Information

Current as of December 22, 2024

Not yet recruiting

Keywords

Abiraterone Microbiome Dexamethasone

ClinConnect Summary

No description provided

Gender

MALE

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.

Trial Officials

Catherine Handy-Marshall, M.D.

Principal Investigator

Johns Hopkins University

About Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is a leading research and treatment facility dedicated to advancing the understanding and treatment of cancer. Renowned for its multidisciplinary approach, the center integrates cutting-edge research with patient care, fostering innovation in cancer therapies and prevention strategies. With a commitment to translational medicine, the center conducts clinical trials that aim to bring laboratory discoveries directly to patients, enhancing therapeutic options and improving outcomes. As a National Cancer Institute-designated comprehensive cancer center, it emphasizes collaboration among researchers, clinicians, and patients to tackle the complexities of cancer and develop personalized treatment plans.

Locations

Baltimore, Maryland, United States

Washington, District Of Columbia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0