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
Shanghai Proton and Heavy Ion Center
140 participants
Oct 15, 2020
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
Inclusion Criteria11
- 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 Criteria5
- No pathologically confirmed adenocarcinoma of the prostate
- Pelvic lymph node metastasis (N1)
- Distant metastasis (M1)
- Previous pelvic radiotherapy
- Previous prostatectomy
Interventions
All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle
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)
View Full Details on ClinicalTrials.gov
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NCT05010343