Phase 2 Prostate Cancer Trial, Recruiting NCT06402357 Sponsor: University of Florida Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06402357
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:

  • You have chosen to have a focused ultrasound treatment (called HIFU) for prostate cancer that has come back after radiation therapy
  • You are male and 18 years of age or older
  • You are able to carry out some or all of your normal daily activities (your doctor can confirm this based on a standard scale from 0–3)
  • Your prostate cancer was previously treated with radiation therapy, with or without hormone therapy
  • You have had an MRI scan or a special type of PET scan (called a PSMA PET scan) that identified a specific area of concern in the prostate
  • A biopsy taken within the last 6 months has confirmed that significant prostate cancer has returned in or near the area identified on your scan
  • Any cancer found on the opposite side of the prostate is a low-grade, less aggressive type (confirm with trial site)
  • Your PSMA PET scan, taken within 6 months of your biopsy, shows the cancer has not spread to other parts of the body
  • You have no more than one active cancer at the time of joining (some exceptions may apply — confirm with trial site)
  • You are willing to give written consent and follow all study procedures

Who may not be able to join:

  • You have a latex allergy, no rectum, or have had significant rectal surgery that would make the ultrasound probe unsafe to use
  • You have received hormone therapy within the 6 months before screening (this includes tablets or injections used to lower or block testosterone)
  • You have had Inflammatory Bowel Disease that required active treatment in the last 3 years
  • Imaging shows your cancer has grown significantly beyond the prostate (confirm with trial site)
  • Significant prostate cancer is found on both sides of the prostate
  • You still have radioactive seeds in your prostate from a previous brachytherapy treatment
  • You have internal marker clips or seeds that would directly block the ultrasound treatment reaching the target area, as assessed by your surgeon
  • You have large calcium deposits in the prostate area that your surgeon feels would interfere with the ultrasound treatment
  • You have had an active urethral narrowing (stricture) in the last 6 months or have needed more treatment than simple self-catheterisation for it
  • You have never had radiation therapy for prostate cancer
  • No specific target area was identified on your MRI or PET scan
  • Your scan shows the cancer has spread to lymph nodes in the pelvis, other parts of the body, or has grown into nearby structures
  • You have another medical condition that your doctor believes would make this treatment unsafe or affect the study results
  • You are currently in prison or being held in a facility against your will

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 28 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: Tarik Benidir, MD, University of Florida

Phone: 352-392-0510

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
14 May 2025
Est. completion
1 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

In-field failure-free survival

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: 28 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