Prostate Cancer Trial, Recruiting NCT04808427 Sponsor: National Cancer Institute (NCI) Condition: Prostate Cancer
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Prostate Cancer Trial, Recruiting

NCT04808427
Recruiting Not Applicable

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:

  • People who have been diagnosed with prostate cancer through a specific type of biopsy (using ultrasound guidance with at least 12 tissue samples, plus targeted samples of any areas visible on MRI), with the diagnosis confirmed by the NCI's Pathology Laboratory
  • People whose prostate cancer has a Gleason Score of 7 or lower (a measure of how aggressive the cancer appears under a microscope)
  • People whose prostate cancer is visible or trackable on an MRI scan, meeting specific location requirements relative to the area planned for treatment (confirm with trial site)
  • People whose cancer is contained within the prostate and is classified as stage T1c or T2a on MRI — this also includes people who have previously had prostate cancer treatment and have a remaining or returning tumor that shows up on MRI
  • People with a PSA blood test result below 20 ng/ml, or above 20 ng/ml only if a related measurement called PSA density is below 0.15 (confirm with trial site)
  • People aged 18 or older
  • People whose blood and kidney function meet the trial's minimum requirements: platelet count at or above 50,000/mcL, haemoglobin at or above 8 g/dL, and kidney filtration rate at or above 30 mL/min/1.73 m²
  • People who are willing and able to read and sign a consent form
  • People who are also enrolled in a separate NCI study about prostate cancer care and tissue collection (protocol 16-C-0010)

Who may not be able to join:

  • People whose targeted treatment area measures more than 5 cm from the bottom to the top of the prostate, or where the lesion extends more than 3 cm from the urethra (the tube that carries urine)
  • People where the area to be treated is larger than 100 ml in volume
  • People who have calcium deposits in the prostate that could block the ultrasound waves needed for the procedure
  • People who are unable to have an MRI scan, for example due to a pacemaker or other implanted device, claustrophobia, or inability to tolerate the equipment used during the scan
  • People with an active urinary tract infection at the time of the trial
  • People with significant urinary symptoms, measured by a standard questionnaire score above 20 (IPSS score)
  • People with uncontrolled blood clotting problems — including certain liver conditions or untreated inherited clotting disorders that have a recognised treatment available — where the treating surgeon considers the bleeding risk to be too high
  • People with serious uncontrolled health conditions, including active or ongoing infections, unstable heart conditions, uncontrolled heart rhythm problems, heart failure with symptoms, or mental health or personal circumstances that the trial team believes would make it difficult to follow the study requirements

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 8 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Peter A Pinto, M.D., National Cancer Institute (NCI)

Phone: (240) 974-9026

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
20 November 2023
Est. completion
1 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

feasibility and tolerability

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: 8 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