Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: carbon ion irradation, Carbon Ion Irradiation With SIB.
- Who it may be relevant to
- Registry conditions: Localized Prostate Cancer. Basic parameters: 45 years — 85 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial
Overview
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.
Detailed description
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.
Interventions
- Radiation 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 - Radiation 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
Primary outcome measures
- Acute toxicities [Time frame: Within 3 months of the start of CIRT]
Secondary outcome measures (4)
- Late toxicities [Time frame: 3 months after the completion of CIRT]
- Biochemical failure free survival [Time frame: From the complation of CIRT,a median of 5 years]
- Overall survival [Time frame: From the diagnosis of prostate cancer,a median of 5 years]
- Progression free survival [Time frame: From the complation of CIRT,a median of 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Proton and Heavy Ion Center — Shanghai
Publications
- Hu W, Li P, Hong Z, Guo X, Pei Y, Zhang Z, Zhang Q. Functional imaging-guided carbon ion irradiation with simultaneous integrated boost for localized prostate cancer: study protocol for a phase II randomized controlled clinical trial. Trials. 2022 Nov 8;23(1):934. doi: 10.1186/s13063-022-06798-5. PMID 36348363
Identifiers
NCT: NCT05010343 · SPHIC-TR-PCa2020-01