Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer
- Conditions
- Localized Prostate Cancer
- Interventions
- Radiation: Carbon Ion Irradiation With SIBRadiation: carbon ion irradation
- Registration Number
- NCT05010343
- Lead Sponsor
- Shanghai Proton and Heavy Ion Center
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 140
- 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
- No pathologically confirmed adenocarcinoma of the prostate
- Pelvic lymph node metastasis (N1)
- Distant metastasis (M1)
- Previous pelvic radiotherapy
- Previous prostatectomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carbon Ion Irradiation With SIB group 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 carbon ion irradation group 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
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Late toxicities 3 months after the completion of CIRT Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale
Progression free survival From the complation of CIRT,a median of 5 years The time from complation of CIRT to tumor progression or death
Biochemical failure free survival From the complation of CIRT,a median of 5 years The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)
Overall survival From the diagnosis of prostate cancer,a median of 5 years The time from diagnosis to death from any cause
Trial Locations
- Locations (1)
Shanghai Proton and Heavy Ion Center
🇨🇳Shanghai, China