A Phase 2 interventional study of carbon ion irradation and Carbon Ion Irradiation With SIB in Localized Prostate Cancer, sponsored by Shanghai Proton and Heavy Ion Center. Recruiting at 1 site in China. Open to male participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-11-15.
Sponsored by Shanghai Proton and Heavy Ion Center · Phase 2, Interventional, and Treatment
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 140 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Shanghai Proton and Heavy Ion Center is the lead sponsor of 28 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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 irradation
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
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
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
Acute toxicities
Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Time frame: Within 3 months of the start of CIRT
Late toxicities
Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale
Time frame: 3 months after the completion of CIRT
Biochemical failure free survival
The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)
Time frame: From the complation of CIRT,a median of 5 years
Overall survival
The time from diagnosis to death from any cause
Time frame: From the diagnosis of prostate cancer,a median of 5 years
Progression free survival
The time from complation of CIRT to tumor progression or death
Time frame: From the complation of CIRT,a median of 5 years
The quality of life-International Prostate Symptom Score (IPSS)
IPSS would be used to assess the severity of lower urinary tract symptoms, based on the answers to seven questions regarding urinary symptoms (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia). Total IPSS score: 1-7: Mild; 8-19: Moderate; 20-35: Severe
Time frame: From the complation of CIRT, a median of 5 years
The quality of life-Expanded Prostate Cancer Index Composite (EPIC)
EPIC would be used to evaluate the urinary, bowel, and sexual symptoms. The EPIC is a patient reported outcomes instrument designed to evaluate bowel, urinary, sexual and hormonal domains both during and after irradiation of the pelvis.For each domain, responses are provided on a 5-point Likert scale, and multi-item scale scores are transformed linearly to a scale of 0 to 100, where higher scores correspond to better quality of life.
Time frame: From the complation of CIRT, a median of 5 years
Plan to share: No
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Shanghai Proton and Heavy Ion Center