Fact CheckerSign in

NCT05754580Recruiting

High-dose Brachytherapy Boost With Stereostatic Body Radiation Therapy to Intermediate or Higher Risk Prostate Cancer

High-dose Rate (HDR) Brachytherapy Boost With Stereostatic Body Radiation Therapy (SBRT) to Prostate and Pelvic Nodes for the Initial Treatment of Unfavorable Intermediate or Higher Risk Prostate Cancer

Source: ClinicalTrials.gov · Last updated 5 Nov 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The objective of this phase I/II trial is to prospectively evaluate the toxicity and therapeutic efficacy of Stereostatic Body Radiation Therapy (SBRT) to prostate and pelvic lymph nodes in combination with high-dose-rate (HDR) brachytherapy to the prostate in patients with localized unfavorable-intermediate risk or higher disease.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
53 (estimated)
First submitted
6 Feb 2023
Start date
29 Aug 2023
Primary completion date
31 Oct 2026
Lead sponsor
University of Nebraska
NCT number
NCT05754580

What you commit to

  • Study type: Interventional
  • Planned participants: 53
  • From 29 Aug 2023 to the primary completion date, 31 Oct 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Large prostate volume relative to pelvic arch width that can hinder proper placement of applicator insertion. To be done by MRI, TRUS, and/or physical exam for size, by CT A/P or MRI for arch interference. Specifically, prostates must be no greater than 75 cc in size as decerned by MRI, TRUS, or physical exam. Potential for pubic arch interference will be decerned by the treating radiation oncologist based on MRI and/or CT imaging.
  • Recent major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to registration.

Other illness

  • Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  • Relative or absolute contraindications to radiation therapy as determined by the treating physician. These include, but not limited to, inflammatory bowel disease, connective tissue disorders (systemic lupus erythematosus, scleroderma, etc.), genetic disorders that risk increase sensitivity to radiation therapy.
  • Medical conditions that, in the opinion of the investigator could compromise patient safety.
  • Prior invasive malignancy other than prostate cancer (except non-melanomatous skin cancer) unless disease free for a minimum of 1 year.
  • History of rectal surgeries.
  • History of Urolift.
  • Preexisting rectal fistula.

Other

  • American Urological Association Urinary Symptom Score (AUA score) ≥ 15.
  • Contraindications to general anesthesia.

Who the study is looking for

  • Histopathologically proven diagnosis of local unfavorable intermediate or higher risk prostate cancer as defined by NCCN risk group criteria. Biopsies will be confirmed by UNMC pathology review if collected outside our institution.
  • No prior definitive treatment or intervention received.
  • Life expectancy of more than 10 years as estimated by the treating physician.
  • Negative evaluation lymph node involvement or distant metastatic disease on abdominopelvic CT, prostate MRI, and/or PSMA PET.
  • Negative evaluation of osseous metastatic disease via bone scan or PSMA PET scan.
  • Greater than or equal to 15% nodal involvement risk predicated on publicly available MSKCC pre-prostatectomy nomogram.
  • Karnofsky performance status ≥ 80 within 30 days prior to registration.
  • Age ≥ 19 years.
  • Clinically determined to be a candidate for HDR brachytherapy.
  • Patient must be able to provide study-specific informed consent prior to study entry.

Age in the registry: 19 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.