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

NCT05010343 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Proton and Heavy Ion Center

Phase

Phase 2

Started

2020-10-15

Last updated

2021-11-15

Condition(s) studied

Localized Prostate Cancer

Investigational drug(s) / intervention(s)

carbon ion irradationCarbon Ion Irradiation With SIB

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

Carbon 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

Study 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

MALE

Min age

45 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: * Pathologically confirmed adenocarcinoma of prostate * Stage cT1-3N0M0 localized prostate cancer * performed PSMA PET/CT and mpMRI before treatment * No lymph nodes or distant metastasis * Age ≥ 45 and \< 85 years of age * Karnofsky Performance Score ≥70 * No previous pelvic radiation therapy (RT) * No previous prostatectomy * No previous invasive cancer (within 5 years before the prostate cancer diagnosis) * Ability to understand character and individual consequences of the clinical trial * Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial Exclusion Criteria: * No pathologically confirmed adenocarcinoma of the prostate * Pelvic lymph node metastasis (N1) * Distant metastasis (M1) * Previous pelvic radiotherapy * Previous prostatectomy

Primary outcome measure(s)

Acute toxicities — Within 3 months of the start of CIRT
Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Trial sites (1)

Facility	City	Region	Status
Shanghai Proton and Heavy Ion Center	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05010343 on ClinicalTrials.gov ↗ ← All trials in China