Prostate Cancer Trial, Recruiting NCT05754580 Sponsor: University of Nebraska Condition: Prostate Cancer
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Prostate Cancer Trial, Recruiting

NCT05754580
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 confirmed by tissue testing, classified as unfavorable intermediate risk or higher risk according to standard medical guidelines (NCCN criteria).
  • People who have not yet received any definitive treatment for their prostate cancer.
  • People whose treating doctor estimates their life expectancy to be more than 10 years.
  • People whose scans (CT, MRI, and/or a specialised PET scan) show no cancer spread to nearby lymph nodes or distant parts of the body.
  • People whose bone scan or specialised PET scan shows no cancer spread to the bones.
  • People whose risk of lymph node involvement is calculated at 15% or higher using a publicly available medical risk calculator (the MSKCC pre-prostatectomy nomogram).
  • People who scored 80 or above on a standard health and activity scale (Karnofsky performance status) within 30 days before joining the trial.
  • People aged 19 years or older.
  • People whose doctor has determined them to be a suitable candidate for a type of internal radiation treatment called HDR brachytherapy.
  • People who are able to give written, informed consent before the trial begins.

Who may not be able to join:

  • People with a urinary symptom score of 15 or higher on the standard AUA urinary symptom questionnaire.
  • People with a prostate that is larger than 75 cc in size, or where the shape of the pelvis may make it difficult to correctly place the treatment device (confirmed with trial site).
  • People experiencing psychological, family, social, or geographic circumstances that may make it difficult to follow the study schedule and attend follow-up appointments.
  • People who have medical reasons that make radiation therapy unsafe, such as inflammatory bowel disease, certain connective tissue disorders (for example, lupus or scleroderma), or genetic conditions that increase sensitivity to radiation.
  • People with other medical conditions that, in the opinion of the research team, could put their safety at risk.
  • People who have had another type of cancer (other than certain non-serious skin cancers) and have not been free of that cancer for at least one year.
  • People who have had surgery on their rectum in the past.
  • People who have had a major surgery, open biopsy, or serious injury within the 30 days before joining the trial.
  • People who have previously had a Urolift procedure (a device used to treat urinary problems).
  • People who have medical reasons that make general anaesthesia unsafe.
  • People who have a pre-existing rectal fistula (an abnormal opening in the rectum).

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
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 J Baine, MD, University of Nebraska

Phone: 402-559-8287

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
Sponsor
University of Nebraska
Registry
ClinicalTrials.gov
Start date
29 August 2023
Est. completion
1 October 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Participants with Treatment-Related Adverse Events

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