RecruitingNot ApplicableNCT05804318

Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer

Daily Adaptive Stereotactic Body Radiation Therapy for Prostate Cancer With Urethral Sparing: A Prospective Trial Using an Individualized Approach to Reduce Urinary Toxicity


Sponsor

Varian, a Siemens Healthineers Company

Enrollment

132 participants

Start Date

Apr 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a prospective, single-arm, multi-center clinical trial designed to assess whether adaptive radiotherapy with urethral sparing for low to intermediate risk localized prostate cancer will translate into a decreased rate of patient reported acute urinary side effects, as measured by the patient reported EPIC-26 questionnaire, compared with the historically reported rate for non-adaptive, non-urethral sparing prostate SBRT.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a highly personalized, daily-adapted form of radiation therapy (called adaptive radiotherapy, or ART) for men with low- or intermediate-risk prostate cancer — adjusting the radiation plan each day based on how the prostate has shifted or changed in the body. **You may be eligible if:** - You are 18 or older - You have been diagnosed with low or intermediate-risk prostate cancer confirmed by biopsy - Your prostate is not too large (80cc or less on MRI) - Your urinary symptoms are mild to moderate (IPSS score 15 or less) - You are in reasonably good health (ECOG 0–2) - You are able to complete questionnaires throughout treatment **You may NOT be eligible if:** - You already have significant bowel or bladder side effects from prior treatment - You have had prior pelvic radiation - You have had a TURP (prostate surgery through the urethra), HIFU, or prostate cryoablation - Your cancer has spread to lymph nodes or outside the prostate capsule - You have active inflammatory bowel disease - You cannot have an MRI or prostate fiducial marker placement 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

DEVICEDaily adaptive SBRT with urethral sparing

The radiation plan for each daily fraction is adapted from the initial plan based on cone beam CT imaging acquired while the participant is laying on the treatment machine.


Locations(7)

Duarte Cancer Center

Duarte, California, United States

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Washington University in St. Louis

St Louis, Missouri, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Universitätsklinikum des Saarlandes (Saarland Univerisity Hospital)

Homburg, Saarland, Germany

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

View Full Details on ClinicalTrials.gov

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NCT05804318


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