Localized Prostate Cancer
Conditions
Keywords
carbon ion irradiation, Simultaneous Integrated Boost, PSMA PET/CT, mpMRI
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.
Interventions
RADIATIONcarbon ion irradation
All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle
RADIATIONCarbon 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
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Late toxicities | 3 months after the completion of CIRT | Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale |
| Overall survival | From the diagnosis of prostate cancer,a median of 5 years | The time from diagnosis to death from any cause |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| The quality of life-Expanded Prostate Cancer Index Composite (EPIC) | From the complation of CIRT, a median of 5 years | 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. |
| The quality of life-International Prostate Symptom Score (IPSS) | From the complation of CIRT, a median of 5 years | 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 |
Countries
China
Outcome results
None listed