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

  • End date
    Jul 1, 2028
  • participants needed
  • sponsor
    Shanghai Proton and Heavy Ion Center
Updated on 23 November 2021


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.


Local recurrences of prostate cancer following radiotherapy often originate from the primary tumor site. Therefore,focal boost to the primary gross tumor has been proposed to increase biochemical disease-free survival (bDFS) without increasing toxicity.

The higher relative biological effectiveness (RBE) and greater cytocidal effect on the intrinsic radiation resistant cancer cells offer carbon ion radiotherapy (CIRT) advantages over conventional radiotherapy. In this study, carbon ion were used to treat localized prostate cancer and simultaneous integrated boost to the gross tumor in the prostate specific membrane antigen (PSMA) PET/CT and multi- parameter MRI.

Condition Localized Prostate Cancer
Treatment carbon ion irradation, Carbon Ion Irradiation With SIB
Clinical Study IdentifierNCT05010343
SponsorShanghai Proton and Heavy Ion Center
Last Modified on23 November 2021


Yes No Not Sure

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
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