RecruitingNot ApplicableNCT05754580

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


Sponsor

University of Nebraska

Enrollment

53 participants

Start Date

Aug 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of high-dose brachytherapy (internal radiation placed directly in the prostate) with stereotactic body radiation therapy (SBRT, a highly precise external radiation technique) for intermediate- to high-risk prostate cancer, to see if this approach controls cancer while minimizing side effects. **You may be eligible if...** - You have been diagnosed with prostate cancer classified as unfavorable intermediate, high, or very high risk (based on standard medical criteria) - This is your first treatment for prostate cancer — you have not had prior surgery, radiation, or hormone therapy - Your life expectancy is estimated to be more than 10 years - Imaging shows no cancer spread to lymph nodes or distant organs **You may NOT be eligible if...** - You have already had treatment for prostate cancer - Your cancer has spread beyond the prostate - You have health conditions that make radiation treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHigh Dose Brachytherapy

This technique involves transient insertion of a stronger (i.e. more active) source (Ir-192) into the prostate, with dose delivery over the course of several minutes followed by immediate removal.

RADIATIONStereostatic Body Radiation Therapy

ultra-hypofractionation radiation therapy.


Locations(1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

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NCT05754580


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