Phase 2 Prostate Cancer Trial, Recruiting NCT06616597 Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06616597
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Males aged 18 years or older
  • People diagnosed with a specific type of prostate cancer called prostate adenocarcinoma
  • People whose PSA level (a prostate cancer marker measured in blood) is 2.0 ng/mL or higher at the screening visit
  • People whose PSA levels have risen — with or without changes visible on scans — after being on the medications abiraterone and prednisone for at least 12 weeks
  • People who are currently on hormone-suppressing injections (GnRH analogues) or who have had surgical removal of the testicles
  • People with a life expectancy of at least 6 months
  • People who are able to swallow tablet medications
  • People willing to avoid alcohol during treatment and for 14 days after taking a study medication called metronidazole
  • People willing and able to collect urine and stool samples as required by the study

Who may not be able to join:

  • People with an active infection or other health condition that would make a steroid medication called dexamethasone unsafe to use
  • People who require ongoing higher doses of steroid medications for a chronic health condition
  • People whose prostate cancer has a specific aggressive cell type called small cell carcinoma
  • People who have, or are at immediate risk of, spinal cord compression based on clinical assessment or MRI scans
  • People with severe chronic liver disease (classified as Child-Pugh class C cirrhosis — confirm with trial site)
  • People with certain abnormal liver blood test results above specified thresholds (confirm exact values with trial site)
  • People with a heart rhythm condition involving a prolonged QTc interval, either inherited or measured above 500 milliseconds on a heart tracing
  • People with a history of problems affecting the pituitary gland or adrenal glands
  • People with poorly controlled diabetes (HbA1c above 10%) or whose insulin doses have been increased in the past 4 weeks due to poor blood sugar control
  • People who have received another experimental treatment or had a major surgical procedure (not including surgical removal of the testicles) within 30 days before the study begins, or who are currently in another experimental drug study
  • People with certain serious illnesses, including uncontrolled major infections, Crohn's disease, ulcerative colitis, toxic megacolon, small bowel blockage, or a known allergy to any of the study medications
  • People who have taken antibiotic medications within 30 days before starting the study treatment
  • People who have any other condition or situation that the trial doctor believes could put them at risk or interfere with their participation

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Catherine Handy Marshall, M.D., Johns Hopkins University

Phone: 410-502-7635

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
13 February 2025
Est. completion
30 March 2031

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants with PSA30 response

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov