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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial

Conditions
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Localized Prostate Cancer

Intervention / Treatment
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* Radiation: carbon ion irradation
* Radiation: Carbon Ion Irradiation With SIB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: carbon ion irradation group<br>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<br>* All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle<br>|
| Active Comparator: Carbon Ion Irradiation With SIB group<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicities | Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 | Within 3 months of the start of CIRT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late toxicities | Treatment related late toxicity assessed by Radiation Therapy Oncology Group (RTOG) scale | 3 months after the completion of CIRT | 
| Biochemical failure free survival | The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition) | From the complation of CIRT,a median of 5 years | 
| Overall survival | The time from diagnosis to death from any cause | 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 | From the complation of CIRT,a median of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carbon ion irradiation, Simultaneous Integrated Boost, PSMA PET/CT, mpMRI