Phase 1 Prostate Cancer Trial, Recruiting NCT05864196 Sponsor: NYU Langone Health Condition: Prostate Cancer
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Phase 1 Prostate Cancer Trial, Recruiting

NCT05864196
Recruiting Phase 1

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 aged 18 or older
  • People who have been diagnosed with a specific type of prostate cancer called adenocarcinoma that is contained within the prostate (localized)
  • People whose prostate cancer diagnosis has been confirmed through a biopsy
  • People whose cancer is classified as low to intermediate risk based on standard cancer guidelines, with a PSA blood test result below 20 ng/ml and a cancer grade of group 3 or lower
  • People whose prostate is smaller than 60cc in size, as measured by an MRI scan taken during treatment planning
  • People who are able to have an MRI scan and have a clearly identified area of concern in the prostate rated at a certain level on a standard imaging scale (PI-RADS score of 3 or higher) — though exceptions may apply for very low, low, or certain intermediate-risk cases (confirm with trial site)
  • People who are able to understand and agree to participate by signing an informed consent form
  • People who agree to use effective contraception methods (such as condoms and spermicidal foam, an intrauterine device, or their partner using prescription birth control pills)
  • People whose treating radiation specialist determines that the rectal area can be properly prepared for treatment

Who may not be able to join:

  • People whose prostate cancer is classified as high risk
  • People whose cancer has spread to the lymph nodes in the pelvis
  • People who require radiation treatment to the pelvic lymph nodes, as determined by their treating radiation specialist
  • People who show signs that the cancer has grown outside the prostate or into nearby structures called seminal vesicles
  • People who have previously had radiation treatment to the pelvis
  • People who have had another cancer diagnosis within the last 5 years
  • People whose prostate is larger than 60cc as measured on their planning MRI
  • People with active significant inflammatory bowel disease or active rheumatological (joint/immune) disease
  • People who have had previous prostate surgery, including a procedure called UroLift, or a procedure called TURP (a type of prostate surgery) within 6 months before the study treatment
  • People who do not meet specific technical radiation dose limits during treatment planning
  • People whose urinary, bowel, or erectile function scores fall below a certain level on a standard questionnaire given before treatment
  • People of reproductive potential who do not agree to use effective contraception during the trial

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 6 July 2026
Phase 1: approximately ~10% 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: Jonathan Lischalk, NYU Langone Health

Phone: 212-496-5845

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 1
Registry
ClinicalTrials.gov
Start date
17 July 2023
Est. completion
1 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Grade 2 or Higher Toxicities per CTCAE version 5.0

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: 6 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