RecruitingPhase 2NCT05010343

Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer

Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial


Sponsor

Shanghai Proton and Heavy Ion Center

Enrollment

140 participants

Start Date

Oct 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography / computed tomography (PET/CT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.


Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using PSMA PET/CT imaging (a very precise scan to detect prostate cancer) alongside carbon ion radiation therapy (a highly targeted form of radiation) improves treatment accuracy and outcomes for men with localized prostate cancer. **You may be eligible if...** - You are between 45 and 84 years old with a confirmed prostate cancer diagnosis (adenocarcinoma) - Your cancer is localized (Stage cT1-3, no lymph node or distant spread) - You have had both a PSMA PET/CT scan and an mpMRI before treatment - You have not had previous pelvic radiation or prostate surgery - You have had no other invasive cancer in the past 5 years **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other organs - You have previously had radiation to the pelvis or prostate surgery - Your general health score (Karnofsky) is below 70 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

RADIATIONcarbon ion irradation

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle

RADIATIONCarbon Ion Irradiation With SIB

All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle, and with simultaneous integrated boost (SIB) to the gross tumor in the PSMA PET/CT and mpMRI


Locations(1)

Shanghai Proton and Heavy Ion Center

Shanghai, China

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NCT05010343


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