Recruiting
Phase 2
Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer
About this study
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.
- Condition
- Localized Prostate Cancer
- Tested
- carbon ion irradation, Carbon Ion Irradiation With SIB
- Sponsor
- Shanghai Proton and Heavy Ion Center
Who can join
- Age
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 15
- Minimum age: 45 years
- Maximum age: 85 years
- Eligible sex: Male
- Study condition: Localized Prostate Cancer
- 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 5
- No pathologically confirmed adenocarcinoma of the prostate
- Pelvic lymph node metastasis (N1)
- Distant metastasis (M1)
- Previous pelvic radiotherapy
- Previous prostatectomy
Where
1 site, 1 recruiting
Shanghai Proton and Heavy Ion Center
Shanghai, China
Potential match only. Final eligibility is determined by the study team.