Prostate Cancer Trial, Recruiting NCT06542757 Sponsor: NYU Langone Health Condition: Prostate Cancer
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Prostate Cancer Trial, Recruiting

NCT06542757
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:

  • You have been diagnosed with intermediate-risk prostate cancer, based on national guidelines
  • Your PSA blood test result is between 10 and 20 ng/ml, OR your Gleason score (a measure of cancer aggressiveness) is 7, OR your cancer has spread within the prostate to more than half of one side or to both sides
  • You are older than 18 years of age
  • You are in good general health, able to carry out normal daily activities with only minor difficulty (confirm with trial site)
  • Your prostate is smaller than 90 cc (a measure of prostate size)
  • An MRI scan has identified a visible area of concern in your prostate of at least 0.5 cm, with no more than two other areas of concern, rated as high suspicion on a standard scoring system
  • Your MRI scan shows the cancer may be touching the outer edge of the prostate, but has not clearly spread beyond it
  • Your urinary symptom score is below 18 on a standard questionnaire, meaning your symptoms are mild to moderate
  • You are willing and able to complete an MRI safety screening form and meet MRI safety requirements

Who may not be able to join:

  • Your Gleason score is higher than 7
  • Your PSA blood test result is above 20 ng/ml
  • You are currently receiving or have previously received hormone therapy to lower testosterone for prostate cancer
  • Your MRI scan strongly suggests the cancer has spread outside the prostate
  • Your MRI scan shows more than two areas of disease in the prostate
  • There is evidence that your cancer has spread to your bones or other parts of your body
  • You cannot have an MRI scan due to a pacemaker, defibrillator, other implanted metal or electronic device, severe fear of enclosed spaces, or inability to lie still for the required time
  • You have a metal implant or device in your pelvis area that could affect MRI image quality
  • Your body measurements are too large to be compatible with the specific MRI technology used in this trial (confirm with trial site)
  • You have an allergy or medical reason preventing you from receiving gadolinium, a dye used during MRI scans
  • You have had a previous procedure to remove prostate tissue through the urethra (TURP)
  • You have a history of urethral stricture (narrowing of the tube that carries urine)
  • You have previously had radiation treatment to your pelvic area
  • You have a history of inflammatory bowel disease
  • Your MRI or CT scan shows the cancer has spread significantly beyond the prostate or to nearby lymph nodes
  • You are unable to give informed consent to participate
  • You are unable to complete quality of life questionnaires
  • Your blood test results show abnormalities, including low platelet count, low haemoglobin (anaemia), low white blood cell count, or poor kidney function

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 26 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: Michael Zelefsky, M.D, NYU Langone Health

Phone: 212-263-4432

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
9 December 2024
Est. completion
1 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Negative biopsy rate 24 months post-treatment; Serious toxicity rate 24 months post-treatment

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: 26 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