Phase 2 Prostate Cancer Trial, Recruiting NCT06397703 Sponsor: NYU Langone Health Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06397703
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:

  • People who have been diagnosed with prostate cancer through a biopsy, classified as "unfavorable intermediate risk," which includes at least one of the following: a Gleason score of 4+3; more than 50% of biopsy samples showing Gleason 7 cancer; or two to three specific intermediate-risk features (Gleason 7, a PSA level between 10–20 ng/mL, or a certain tumour stage known as T2b–T2c)
  • People who have tumour tissue available that can be sent for a specific genetic test called a Decipher score, with results ready before treatment begins
  • People whose testosterone level was measured at 150 ng/dL or above within the two months before joining the trial
  • People who have had at least four weeks pass since any major surgery
  • People who score 80% or higher on a general health and ability scale called the Karnofsky Performance Scale
  • People whose prostate is smaller than 90 cc in size, as measured by an MRI or CT scan
  • People who score 20 or lower on a urinary symptom questionnaire called the IPSS
  • People who are able to attend follow-up appointments (after two years, follow-up by phone or medical record review is acceptable)
  • People whose liver function blood test results are within an acceptable range as determined by the trial site (confirm with trial site for specific values)
  • People whose kidney function blood test results are within an acceptable range as determined by the trial site (confirm with trial site for specific values)
  • People whose blood counts — including white blood cells, platelets, and haemoglobin — meet minimum levels set by the trial (people whose low haemoglobin has been corrected with a blood transfusion may still be eligible)

Who may not be able to join:

  • People whose scans (CT, MRI, or PET) show that prostate cancer has spread to the bones
  • People whose scans show one or more lymph nodes that appear suspicious for cancer spread
  • People who have previously received treatment for prostate cancer, including chemotherapy, hormone therapy within 30 days of joining, or prostate surgery — although certain prior procedures to relieve urinary blockage (TURP or greenlight PVP) are allowed
  • People who have had another cancer diagnosed within the past two years, unless it was a skin cancer (basal cell or squamous cell) that was fully treated, a superficial bladder cancer now in complete remission, or any other cancer that has been in complete remission for at least three years
  • People who have Crohn's disease or ulcerative colitis

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 13 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: Michael Zelefsky, NYU Langone Health

Phone: 347-266-2630

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
16 April 2024
Est. completion
16 April 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Disease-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: 13 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