Recruiting EARLY_PHASE1 Prostate Cancer

New treatment option for Prostate Cancer

Official title Akkermansia Muciniphilia and Metabolic Side Effects of ADT

ClinicalTrials.gov ID: NCT05802121

What this study is testing

What is Apple Cider Vinegar?

Apple Cider Vinegar is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for prostate cancer.

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
The overriding objectives of this study are: 1. Primary outcomes: 1.
  • Phase 1: an early, usually small safety study

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

  • For inclusion in this study, patients must fulfill all of the following criteria:
  • Men ≥18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany...
  • Must have baseline imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET scan Patients fulfilling any of the following criteria...
  • Age less than 18
  • Primary neuroendocrine prostate cancer
See the full eligibility criteria
Who can join
  • For inclusion in this study, patients must fulfill all of the following criteria:
  • Men ≥18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany, M1) (see Appendix I).
  • Must have baseline imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET scan Patients fulfilling any of the following criteria are NOT eligible for participation in this study:
  • Age less than 18
  • Primary neuroendocrine prostate cancer
  • Treatment with ADT within the year leading up to enrolment
  • Planned or concurrent use of chromium supplementation for the study duration
  • Planned or concurrent use of apple cider vinegar supplementation for the study duration
  • Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter)
  • Inadequate liver function (\>2x upper limit of normal)
  • Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the Qualified Investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant...
  • Use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial

The study team makes the final eligibility decision.

Where it's taking place

  • London, Ontario, Canada

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 London, Ontario, Canada. 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.