RecruitingNot ApplicableNCT05350475

Protons Vs. Photons for High-risk Prostate Cancer

Lymph Node Radiation Therapy with Integrated Boost to Prostate for High-risk Prostate Cancer a Randomized Phase 3 Trial Comparing Photons Vs. Protons


Sponsor

University of Aarhus

Enrollment

400 participants

Start Date

Mar 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of radiation therapy — proton therapy and standard photon (X-ray) radiation — for men with high-risk or locally advanced prostate cancer. Both treatments target the same area, but proton therapy uses a different type of particle beam and may cause fewer side effects to nearby healthy tissue. **You may be eligible if...** - You are 18 or older with confirmed prostate cancer (stages T1 to T3b, no distant spread) - Your PSA is below 100 ng/mL - Your cancer requires treatment of the lymph nodes as well - You are generally healthy and have a life expectancy of at least 10 years - You have not previously been treated for prostate cancer **You may NOT be eligible if...** - You have hip replacements or other metal implants in the pelvic area (except small fiducial markers) - You have had major abdominal or rectal surgery - You have had another cancer in the past 5 years (except skin cancer) - You have inflammatory bowel disease - You are unable to understand or follow treatment instructions (including language barriers) 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

RADIATIONProton therapy

Patients in the experimental arm will receive proton therapy within the same dose and fraction schedule as patients receiving photon therapy, which is standard treatment.

RADIATIONPhoton therapy

Patients in the photon arm will receive standard treatment with photon therapy.


Locations(7)

Dept. of Oncology, Rigshospitalet, Denmark

Copenhagen, Capital Region, Denmark

Department of Oncology, Copenhagen University Hospital Herlev

Herlev, Capital Region, Denmark

Department of Oncology, Aarhus University Hospital

Aarhus, Central Region, Denmark

Dept. of Oncology, Aalborg University Hospital

Aalborg, Region North, Denmark

Dept. of Oncology, Zealand University Hospital, Denmark

Næstved, Region Sjælland, Denmark

Department of Oncology, Odense University Hospital

Odense, Region South, Denmark

Department of Oncology, Vejle Hospital, Denmark

Vejle, Region South, Denmark

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NCT05350475


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